Project Management Fort Collins

Dr. Cinderella Lessmann

**** ******** **.

Fort Collins, Colorado 80526

970-***-****/ 970-***-****

**.*.********@*******.***

PROFESSIONAL SUMMARY:

Worked on clinical development strategy, study design & analysis, working with biostatisticians to develop requirements/sample size, perform data analysis, interpretation & reporting, scenario planning and medical writing.

Applied and stayed current on drugs and medical devices regulations, including USP, ICH and FDA regulations for cGMP and GLP independently.

Advised on project decisions with potential regulatory consequences.

Developed and executed regulatory strategies for international submissions and product launches.

Prepared, reviewed, and submitted regulatory filings to global health authorities.

Ensured compliance with international medical device regulations, including EU MDR, Health Canada, TGA, and other global regulatory bodies.

Collaborated with cross-functional teams to support global market entry and expansion.

Provided expert guidance on Class I, II, and III medical device regulations and post-market requirements.

Extensive experience in Regulatory Affairs for Class I, II, and III medical devices.

Proven track record of successful international regulatory submissions.

Strong knowledge of global medical device regulations, including FDA, EU MDR, and other international markets.

Adhered to validated test methods, standard operating procedures, and applicable industry guidance.

Execution of compendial methods, specifically USP and EP.

Independently perform sample analyses.

Efficiently analyzed samples of drug products, drug substance, and/or excipient(s).

Assisted other departments in analyzing samples.

Maintained and reviewed laboratory notebooks according to cGMP standards and in-house standard operating procedures (SOPs).

Recorded detailed observations. Tabulated, analyzed, reviewed, and interpreted data from analytical tests.

Led analytical test method design, development, qualification, and validation.

Performed equipment troubleshooting, maintenance, and minor repairs.

Assist the Quality Control (QC) laboratory in troubleshooting test method issues.

Efficiently wrote and reviewed technical reports, summaries, protocols, test methods, standard operating procedures.

Used technical discretion in designing, executing, and interpreting experiments that contributed to project strategies.

Served as contact for vendors and contract laboratories.

Interacted closely with project teams across departments and outside testing laboratories.

Interpreted, reviewed, and discussed data from outside testing laboratories.

Provided analytical support to Formulation Development and interact with team members in exchanging technical expertise.

Served as a subject matter expert (SME) (instrumentation, methodology, guidance, etc.).

Apply statistics for analytical chemistry, data trending, out of specification data, and method development and validation.

Performed risk assessments for supplier and compendial changes.

Served as a project lead.

Allocated lab resources effectively (staff, budget, materials, etc.).

Introduced new concepts, practices, instrumentation, techniques, and methodology that can be leveraged to solve current research questions.

Advise senior management on project technical details

Express scientific creativity in solving current R&D challenges.

Participated in required annual hazardous waste training. Hazardous waste involvement included but was not limited to container and tank management and inspections, generation of hazardous waste as a part of production and sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage.

Responsible for daily activities and supervising staff that were hazardous waste generators and/or handlers.

Responded to spills according to the Chemical Spill Response procedure.

Performed report, protocol, test method, and specification approvals.

Demonstrated proficiency in operating analytical laboratory instruments such as HPLC, GC, FTIR, pH, GC, UV-VIS spectrophotometry, TLC, Karl Fischer titration, rheometric.

Proficient with sample preparation from a variety of matrices.

Experience with FDA regulations, USP, NF, ICH, EP, and their application in the laboratory.

Advanced writing and accurate review of technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or submission to government agencies.

Demonstrated understanding of drug product formulation development.

Demonstrated understanding of critical quality attributes (CQAs) of drug products based on formulation and stability.

Extensive experience with laboratory and wet chemistry techniques (e.g., weighing, volumetric glassware, titrations, etc.).

Experience in equipment troubleshooting, maintenance, and repairs.

Experience with the use of electronic document management system(s).

Extensive experience using word processing, spreadsheet, and database programs. Experienced with MS Office.

Experience with computer systems for sample tracking, laboratory equipment, and raw data handling.

Skills

Demonstrated proficiency with test method development and validation.

Learned and applied new techniques

Ability to present in team meetings.

Attention to detail. Efficient, accurate, and consistent in data compilation and review.

Worked independently and with other analysts, handled multiple projects and timelines concurrently.

Demonstrated problem-solving in a timely manner.

Consistently operated with the highest standards of ethics and compliance.

Took ownership of your actions, success and setbacks.

Went the extra mile to make things happen.

Built and implemented regulatory program in a manner to ensure compliance with applicable U.S. and foreign laws, regulations, and regulatory guidance.

Advised internal clients, including management on regulatory compliance and reporting requirements.

Built relationships, and communicated regularly, with regulators including with respect to investigations and inquiries.

Counseled internal clients, managed, and supervised the preparation, drafting and submission of regulatory filings and other documents with applicable governmental agencies.

Advised executive management regarding material risks, requirements and opportunities related to the regulatory environment.

Conducted research and analysis to support the Legal Team and other internal clients in identifying relevant laws, regulations, and precedents.

Maintained an up-to-the-date knowledge database and reporting system to ensure the relevant personnel were aware of U.S. and foreign laws and regulations impacting company, components, and technology.

Advised the Legal, Compliance, EHS, Engineering, Product, and other internal teams on actual, alleged, and suspected regulatory noncompliance.

Built and developed an in-house team of regulatory experts and analysts to provide advice, counsel, research, drafting and work product, internal clients, and management on matters of regulatory law, safety, and compliance.

Served as the lead regulatory expert on internal investigative and safety reporting and compliance working groups.

Built, implemented, and trained personnel on regulatory compliance.

Engaged and managed appropriate outside resources, including outside counsel, to assist in regulatory matters.

Ensured planned device development activities with US regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues.

Planned and prepared complex regulatory documents for US (PMA, IDE, IDE supplements and annual reports, FDA meetings) and potentially OUS submissions.

Prepared clear, complete, and accurate documents that were logically constructed and comprehensive in content and on time.

Reviewed labeling and packaging components for new products/indication extensions to ensure accuracy and compliance with regulations and aligned with the commercial needs.

Directed and authored regulatory submission; managed the authorship and publication of electronic submissions.

Prepared, submitted, and managed global regulatory applications as well as internal regulatory file documentation.

Maintained systems for tracking current projects and for projection of future activity loads.

Managed systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process.

Worked on clinical development strategy, study design & analysis, working with biostatisticians to develop requirements/sample size, perform data analysis, interpretation & reporting, scenario planning and medical writing.

Led a team to develop/implement effective CMC regulatory strategies for submissions IND/CTA/BLA/MAA) and identify regulatory risk.

Provided strategic advice to manufacturing and quality teams on complex technical and regulatory CMC topics.

Partnered closely with senior leaders and key stakeholders to help working teams navigate emerging issues.

Worked collaboratively with other members of the regulatory organization to ensure alignment on regulatory strategies and priorities were aligned.

Reviewed documents for submission-readiness, to ensure that all submissions conform to health authority guidelines and met the need of the company.

Led Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions at the expert level.

Developed regulatory processes and procedures to support CMC components of regulatory submissions.

Supported the creation and maintenance of CMC submission templates.

Provided interpretation of domestic and international regulatory guidance documents, regulations and directives – advised Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs.

Directed and authored regulatory submission; managed the authorship and publication of electronic submissions.

Authored and published electronic submissions.

Performed comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies and stayed informed about applicable clinical landscapes and trends.

Understand scientific and research methodology, medical device regulations and guidelines, and product knowledge to support Regulatory Affairs submissions for CE marking of new devices and maintaining CE marks for existing devices.

Experience clearing devices in US and EU

Assisted in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.

Deliver innovative regulatory strategies and high-quality submissions that produce timely and predictable worldwide regulatory approvals.

Led a team of Regulatory Affairs Specialists in the management of new product development/modification projects to establish and integrate regulatory submissions strategy into project activities.

Coached team members in the preparation of submissions (i.e., CMC, 510k, CE marking applications, technical documentation, etc.) to obtain domestic US filings, European regulatory approvals, and maintain existing regulatory approvals through letter to file, renewals, change notifications.

In collaboration with International Regulatory Affairs, determined applicable registration requirements for medical devices in all countries in which products were to be registered.

Interpreted and evaluated proposed registration requirements for medical devices and advised on impact of such regulations to the company.

Contributed to team resourcing and project timeline planning.

Reviewed Q-Subs that was used to present classification and submission pathway for a novel technology with breakthrough designation.

Provided guidelines and served in a advisory capacity to tweak the Q-subs.

Was part of the interactions with FDA and provided interpretations and consultancy based on FDA feedback.

Guided the customer with respect to presenting information to FDA to get the right classification of the product. In the process,

Reviewed the current clinical documentation.

Studied existing clinical literature.

Advice on risk management.

Experience developing and leading regulatory strategies to support product launches.

Has extensive experience preparation of submissions, supplements, and correspondence with regulatory authorities, including FDA 510(k), Premarket Approval Application (PMA), De Novo authorizations, and Investigational Device Exemption (IDE) applications.

Has consulted on device/product classification and risk management.

Experience with product submissions related to cancer diagnostics and treatment devices.

Supported domestic and international manufacturing facilities with foreign government and regulatory body inspections.

Maintained proficiency on global regulatory requirements; developed and maintained rapport with regulatory reviewers and project team members.

Maintained regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies.

Directed and performed coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

Led and compiled all materials required in submissions, license renewal and annual registrations.

Communicated issues to management through project management tracking and issue briefings.

Elevated level of effective verbal and written communication skills ability to negotiate, influence, and manage conflict.

Prior regulatory experience with IVDs and medical devices.

Reviewed significant regulatory issues with supervisor, and resolved submission issues with engineering partners, Geography Regulatory partners, and regulatory agencies.

Prepared regulatory strategies/plans and compliance requirements.

Provided on-going support to project teams for regulatory issues and questions.

Interpreted and applied regulations and guidance for situations.

Provided business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams.

Provided regulatory support for currently marketed products. Which included reviewing labelling and changes to existing devices and documentation.

Prepared submissions and reports for regulatory agencies.

Participated in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, requirements on testing.

Provided regulatory analysis of product portfolio and reviewed with other functional resources, such as Marketing, Global Supply Chain, etc., to ensure Mechanical Circulatory Support (MCS) portfolio was aligned with existing portfolio.

Maintained Regulatory Affairs product files to support compliance with regulatory requirements.

Product classification; Definition of applicable standards; Conformity assessment procedures.

Ability to work constructively, decisively, and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.

Ability to communicate effectively in writing crisp briefings and issue analysis.

Ability to work effectively in a team environment.

Responsible for writing and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.

Responsible for effective communication of regulatory requirements to project teams and internal customers.

Extracted data from included studies, interpreted study results, synthesized literature, and prepared summaries into formal reports.

Organized clinical data from literature into references, graphics, tables, and data listings.

Prepared regulatory documents and response to regulatory authorities.

Managed CMC timelines required by product development teams and global regulatory bodies by utilizing the appropriate project management tools.

Communicated with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, and Regulatory Affairs relating to the CMC process to identify the necessary clinical and technical information for assigned project.

Ensured documents were produced per procedures, internal and external guidelines, and electronic templates.

Authored protocols and routine clinical study progress report.

Effectively prepared regulatory files and provided support for maintenance activities in adherence with applicable legislation, and guidelines facilitating approvals and continued client compliance.

Prepared FDA INDs, NDAs, 510Ks, PMAs, CTAs and post-approval submissions.

Updated Module 2 clinical and non-clinical summaries for filing.

Managed and ensured maintenance of a positive and productive liaison with internal and external contacts, including regulatory agencies, clients, and related institutions.

Assigned Regulatory Affairs (RA) professionals to serve on development project teams as core team members.

communicated regulatory strategy for new products.

Working knowledge of Risk Evaluation Mitigation Strategy (REMS) programs.

Responsible for all aspects of the US Regulatory Strategy for assigned development and marketed products.

Member of the Regulatory Product Team (RPT) providing US focused product strategy, US regulatory framework, and awareness of external regulatory initiatives.

Partnered with the Global Regulatory Lead (GRL) and participated in cross-functional project teams representing Regulatory on an agenda driven basis.

Presented the US regulatory position on assigned products to senior management governance committees.

Experience authoring FDA submission documents and REMS assessment reports.

Good knowledge of pharmacovigilance/drug safety, drug regulatory affairs, clinical research, and health economics outcomes research (HEOR)

Provided REMS strategic expertise, leadership and accountability to internal teams and customers for consulting deliverables.

Supported consulting engagements with new and existing clients by contributing to REMS strategy and design, FDA submissions, assessment metric design, REMS survey protocols, and REMS audit protocols.

Collaborated with Business Units to deliver comprehensive REMS solutions to clients. Participated in conferences, team meetings, client, and FDA meetings to represent solutions.

Directed development and review processes for proposed labelling for compliance with applicable regulations.

Reviewed, evaluated, and approved promotion and advertising material for compliance with applicable regulations.

Assessed one or more aspects of a patient’s health status based on information gathered directly from the patient, without interpretation by clinicians. Patients provided information concerning the impact of intervention from their perspective. Means for capturing treatment benefit in terms of how a patient feels and functions because of a therapeutic intervention.

Collected and evaluated drivers of patients’ disease- and treatment-related behaviour.

Examined patient insights on current treatment & perspectives on target product profiles.

Advised on the use and development of COA instruments in clinical research projects including gap analyses, implementation, statistical analyses, validation, and dissemination.

Conducted qualitative and quantitative research to inform development on conceptual disease-models and to support analyses of unmet clinical need and potential therapeutic preferences.

Prepared relevant sections of documentation and communication and questions for regulatory and payer agency meetings, supported, and participated in said meetings, and provided robust evidence in support of submission activities.

12+ years of experience in generating submissions, technical files, and other documentation in support of medical device/IVD registration outside the USA.

7+ years building and supervising a successful regulatory team.

Familiarity with medical devices and/or IVD design control processes.

Strong regulatory strategic thinker with the skills to present resourcing, timeline, and tradeoff scenarios to company leadership regarding global deployment of regulated product.

Experience with good manufacturing practice (cGMP) and good document practice.

Experience with quality systems in regulated space preferred, with responsibility for generating new documents and conducting team reviews.

Experience with successful preparation and submission of 510(k) or PMA, and international registration and marketing of medical device worldwide.

Software as a Medical Device 510k submissions experience.

Demonstrated experience with FDA pre-submissions.

Strong understanding of clinical trial data needed for 510k submissions.

Prepared abstracts and manuscripts presenting COA results from clinical and COA development and validation studies, aligned with publication strategy.

Oversaw the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status of the product.

Provided support and supervision to processes.

Interpreted and applied regulations to business practices and provided regulatory input, advice, and guidance to the organization.

Established and approved RA policy and procedures and ensured compliance with them, including training RA team and cross-functional groups.

Communicated with all areas of business informing of regulatory requirements and emerging issues which may affect the registration approval of products.

Communicated with Regulatory and governmental agencies.

Responsible for establishing prioritization of departmental tasks and projects.

Directed and oversaw the work of regulatory professionals, including training, mentoring, and ensuring professional development.

Served as a departmental knowledge resource, counselling, advising, and training on most facets of departmental function.

Supported markets with product registrations and submissions by creating and maintaining technical and regulatory documentation.

Responsible for leading a team of regulatory professionals who are responsible and accountable for all product registrations globally, in collaboration with cross-functional and global teams. This includes supporting all Health.

Authority interactions, strategic regulatory direction for New Product Development project teams, review

of U.S. and international regulatory submissions, leading review of advertisement and promotional materials and managing regulatory personnel.

Led Client teams by combining deep regulatory experience with insight into client pressures to develop the right solution for the client.

Developed in-depth project management skills and business understanding, knowledge, and experience to independently make effective decisions and act.

Provided oversight of large, complex outsourcing programs and provided direction to project teams to achieve operational excellence, delivering projects/programs on time, to budget, to the highest quality, and that exceed client expectations.

Helped develop new and innovative solutions through continued focus on thought leadership and aligning for end-to-end solutions.

Utilized regulatory, project management expertise to oversee and support the development, review, and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents.

Engaged in and contributed to Labeling Team discussions around content and format of documents, as well as downstream impact on LPDs worldwide.

Acted as a reviewer and signatory during review of labeling ensuring that content complies with regulatory requirements and guidelines, company policies, procedures and that the label content could be transcribed into the LPDs worldwide.

Prioritized Labeling Team activities and set clear targets using project management tools. Follow up with Labeling Team members to secure their contributions so that internal and external deadlines are met. Identify and assist teams to overcome barriers in achieving quality and compliance.

Communicated label update plans to the Hub Labeling Managers in a timely manner.

Ensured all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance was maintained. Ensured appropriate tracking of labeling projects via defined procedures and optimal use of systems.

Facilitated cross-functional and team awareness and understanding of regulatory issues.

Supported Client Relationship Directors and Consultative Sales Directors to drive account expansion in existing accounts and provided subject matter expertise leading to new account acquisition.

Monitored and evaluated industry and competitor initiatives, changes in policy, and technology trends that affected the industry to ensure the highest standard of delivery to the client.

Focused on preparing, writing, editing, and reviewing regulatory (e.g. CMCs, CRM, CSRs clinical data reports/summaries) documents, CSRs early development study designs, Ib/2a patient population experience, gap assessments, drafting responses to EMA Day 150 clinical questions related to the MAA submission for a biosimilar and responses to regulatory authorities notified bodies, conducted document quality review (DQR) on the clinical components of documents authored by Vaccine Clinical Research & Development (VCRD). DQR includes clinical data checking, consistency checking, and editorial review according to client and VCRD clinical guidelines and supported NDA, RMPs, CSR’s, CE Mark for Class I, II, III Devices, CTD Summaries, MEDDEV 2.7/2, ANDA, IND, CBE30, IDE, PMA-S, CSRs and 510Ks documents and filings for Class I, II, III, medical devices.

Wrote, reviewed, and edited scientific manuscripts, clinical study reports, plan outlines, CMC’s, SOP’s, CRM, CTAs, ORPHAN DRUG APPLICATION, MAA SUMMARIES, protocols, Informed consent, SAE Narratives, gap assessments, Patient Narratives, AE Narratives and documents for regulatory submissions (e.g. meeting packages, investigational new drug [INDs] applications, and sections of marketing applications [NDA/ MAA/ CTD], investigator brochures, posters, newsletters, 510k, ANDA, PMA, BLA’s and other clinical and regulatory documents.

Wrote Clinical Study Reports for Phases 1-4 trials, including full study reports, abbreviated reports, web synopses, subject narratives.

Compiled and supported regulatory documentation within the eQMS System.

Coordinated efforts associated with the preparation of regulatory documents and submissions.

Sent all submissions to the associated regulatory agencies, either electronically or by paper documentation.

Analysed product complaints, including adverse drug reactions, and made recommendations about their reportability. Filed all related reports in accordance with regulatory agencies.

Communicated with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification and follow-up of submissions.

Interpreted regulatory rules and rule changes and ensured they were communicated effectively throughout the company and through corporate policies and procedures.

Provided technical review of data and reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

Reviewed product promotional materials, labelling, batch records, specification sheets, and test methods for compliance with applicable regulations and policies.

Advised project teams and other departments on subjects such as premarket regulatory requirements, export and labelling requirements, and clinical study compliance issues.

Determined the types of regulatory submissions (PAS, CBE, and annual reporting) required for proposed product changes and labelling changes.

Conducted monitoring, audits, training, and proctoring of investigational centers while ensuring compliance with FDA, GCP, and ICH guidelines. Conducted trial activities in a fast-paced environment for sites to ensure accurate/rapid data collection with history of minimal deviations for PMA submission.

Responsible for performing Clinical Evaluations and writing/updating CMC associated documents, templates, and processes in compliance with MEDDEV 2.7.1 Rev. 4 and the European Union (EU) Medical Device Regulation (MDR).

Responsible for preparing and submitting moderately complex regulatory documents which require extensive interactions with departments outside of Regulatory Affairs for maintenance of products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.

Examples included safety reports, protocol and information amendments, new investigator amendments, responses to health authority requests for information, labelling supplements and NDA annual reports.

Contributed to the development and Regulatory review of documents required for maintenance of products in assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.

Examples include aggregate safety reports (PSUR, DSUR, etc), clinical protocols, clinical study reports, investigator brochures, Module 2 documents, US labelling documents and other product-related documents.

Ensured that regulatory documents were accurate, complete, and verifiable, and confirm compliance with

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