P: 516-***-**** / E: firstname.lastname@example.org
A PHARMACEUTICAL AND BIOTECHNOLOGY MANAGEMENT PROFESSIONAL seeking leadership position in Regulatory Affairs that provides the opportunity to lead a team of individuals to successfully develop and commercialize products using Regulatory and Quality Sciences. Have demonstrated a robust ability to lead teams from product development, engineering, tech transfer, quality assurance, quality control and regulatory, successfully preparing global submissions with 1st pass approvals to the market place.
Highly determined, mastered individual with 30+ years pharmaceutical/biotech experience, with an in-depth knowledge and understanding of Regulatory Affairs. Displayed successful leadership roles in directing all required product focused activities, creating optimal regulatory strategies for both developmental and commercial products through global supply chain. Skillfully set strategic visions and collaborative work ethic with key stakeholders to cultivate alliance and form highly effective/efficient teams to achieve optimal results. Demonstrated abilities in creating quality and regulatory systems that allow sustainable cGMP/GCP/GLP and Regulatory Compliance with global health authorities. Instituted a comprehensive "rehabilitation program” for a Pharma Company shut down by the FDA and transformed it into a sustainable GMP compliant operation.
I consider myself a hybrid(trifecta)in Clinical/CMC Regulatory Affairs, Drug Development and Quality that allows me to orchestrate all aspects of regulatory affairs more effectively.
SAREPTA THERAPEUTICS Cambridge, MA [May 2017-March 2019]
HEAD OF GLOBAL REGULATORY AFFAIRS CMC
Have successfully managed to submit two back to back NDA’s for two oligonucleotides for DMD within a period of 6 months, while sustaining normal work load of managing all other regulatory activities. Also submitted were two critical IND’s for Gene Therapy for Micro Dystrophin and Limb-Girdle (LGMD) for DMD, working in collaboration with other business partners. Worked closely with our clinical and global supply chain to assure clinical supplies are available on time, through IND and IMPD amendments. Worked in collaboration with the Quality team and QP(Europe) to allow clinical material releases on time.
Lead, build, motivate and direct a department of regulatory experts and be accountable for delivering global regulatory strategy and submissions for all products through clinical trials and initial marketing applications.
Responsible for assuring timely and high quality submissions of IND, IMPD, NDA, NDS and MAA applications and all post approval product lifecycle management activities.
Influenced the adoption of novel manufacturing and control technologies, collaborating with the leadership team that includes drug development, manufacturing, clinical, nonclinical and post approval CMC leads.
Global accountability for RA-CMC regulatory activities for all small molecules including oligonucleotides development program at Sarepta, as well as conducting due diligence on in-licensing assets acquired through acquisitions or joint ventures including gene therapy products namely Micro-Dystrophin and Limb-Girdle IND submissions.
Established and directed appropriate agency communications including Pre NDA meetings, preparation of briefing book, set up other regulatory meetings and ad-hoc product specific agency dialogue.
Responsible for filing 2 NDA(Domestic) and 1 MAA application in Europe and initiation of regulatory submissions to Israel, Saudi Arabia, Brazil, Japan and ROW.
Recruited by Sarepta to head the global CMC team. Re-structured and aligned the team to allow each of the CMC leads to manage specific products from pre NDA to post approval product life cycle management.
Established improvements in the change control module developing a grid system within EtQ Reliance to allow complete traceability of RA-CMC assessments on proposed change, its impact assessment on application type i.e. IND, IMPD, NDA and MAA, and the filing type i.e. CBE 30, Type I or II or a Level 1,2, 3 or 4 change, IND amendment or a substantial amendment to an IMPD. The system is capable of tracing pre and post approval changes, creating crystal reports to aid annual regulatory reporting activities.
Managed to hire new talent to allow growth and development of the RA-CMC team. Doubled the talent pool within RA-CMC to allow effective allocation of resources and manage more global market expansion.
Instituted transparency and open communication between RA-CMC team and other stakeholders within the company, creating comradery and understanding team expectations.
LACHMAN CONSULTING SERVICES/DEAN PHARMA Suffolk County, NY, [April 2014-April 2017] 3 Years
SENIOR REGULATORY AND QUALITY CONSULTANT AT LACHMAN AND PRINCIPAL CONSULTANT FOR DEAN PHARMA CONSULTING SERVICES (TAX ID 27-1XXX565)
Worked with 4 Major Pharmaceutical/ Biotech and Dietary Supplement clients consulting on Regulatory CMC, Quality and Compliance challenges:
Client 1 – Worked with a Major Pharmaceutical client:
Executing planning and preparation of global regulatory global submissions (eg, INDs, CTAs, IND safety reports, meeting requests). This included providing guidance on clinical protocols, CMC activities and overall global regulatory submission strategy.
Managed meeting requests, briefing documents, schedule teleconferences with regulatory agencies for Clinical/CMC issues for Pre IND, EOP2 and Pre NDA/BLA in preparation of planned submissions.
Review of to be filed submissions - IND, CTAs, and IMPD etc. in support of filing of the final NDA, MAA, or BLA applications. Provide advice and counseling on mitigation of any risk.
Client 2 - A Major player in the Dietary Supplement /Nutraceutical business on a retainer contract. Regulated under CFR 111 requirements. Contract agreement to Direct Global Quality/ Laboratory Services responsible for managing 7 Sites Globally.
Ensured that all Quality Systems are harmonized within the network (7 Plants globally).
Directed and established Global Stability program at the Central Laboratory at Bohemia NY site.
Administered CAPEX (Capital Expenditure budget) of 1.8-2 million dollars for the Quality organization advising and counseling on procurement of quality and lab equipment.
Responsible to develop the quality organization to meet their business needs, assuring to sustain compliance with all regulatory authorities.
Advised on all Regulatory or Customer GMP/GLP inspection at the sites.
Consulted on inspections/responses to observations, establishing appropriate CAPA (mitigation plans) to avoid re-occurrences for all sites within the network.
Client 3- A Major Pharmaceutical client executing compliance of CMC activities of filed NDA and BLA.
Reviewed all NDA/BLA, CMC change controls assessed. Advised on dispositions executed to meet regulatory requirements, whether it be a PAS, CBE 0, CBE 30 or an annual reportable change.
Reviewed post approval fillings on changes in manufacturing processes, qualification of secondary suppliers/manufacturers, manufacturing site changes etc.
Advised on Validation of Aseptic line for a parental product.
Reviewed annual product review, identified flaws and amended reports to meet regulatory expectations.
Client 4- International Pharmaceutical client executing filing of NDA with the FDA
Ensured that all Quality Systems are harmonized within the network (7 Plants globally).
Provided guidance on setting up Pre IND, Pre NDA meeting with the Center (CDER) as well as, how to address CMC questions that may arise during the review process.
Advised and trained R&D and Tech Transfer teams on writing development reports bearing in mind concepts of Design Space and Quality by Design (QbD).
Discussed the Do’s and Don’ts of what needs to be included in Module 3 of the NDA and BLA submissions.
SENIOR DIRECTOR OF GLOBAL REGULATORY CMC [Nov 2009 – March 2014]
Managed Regulatory Affairs CMC group to handle Forest’s Global RA filling activities.
Executed preparation, submission and maintenance of regulatory submissions for NDA, BLA, ANDA, NDS, MAA and DMF in accordance with CTD/eCTD requirements. Managed Clinical and CMC program that included drug development, filling strategy for regulatory global submissions (5 NDA, 2 NDS,
1 MAA) and multiple post approval activities.
Represented Regulatory Affairs team on all global due diligence activities (approximately 21) from 2009 to 2014, in reference to product acquisitions.
Ensured that quality by design (QbD) concepts are incorporated into the development programs.
Worked in collaboration with R&D and Global Tech Transfer group, and provided regulatory strategy recommendations and guidance to allow successful filling of dossier with domestic/global health authorities.
Established regulatory affairs strategies of products through all phases of clinical development through filing of IND, CTAs, and IMPD and subsequent amendments and safety reports. Managed all interactions with global regulatory agencies on regulatory issues.
Effectively managed all Post Approval Submission, Change Control and Annual Product Reporting/Review activities for all Forest’s marketed products.
Ensure conformance of all Quality systems (internal and external) to be in sync with regulatory filings/commitments and support product GMP/PAI inspections by global regulatory authorities.
In order to allow participation and initiate improving internal departmental standards and systems, I established RAMS (Regulatory Assessments Management System) that allowed review of global change controls between QA/RA-CMC groups. This forum provided an effective assessment of change controls and impact assessment on various products, sites (internal/external), GMP, QC and regulatory dossiers and a learning platform for product leads on various products.
Streamlined templates for eCTD module 3 to establish high quality regulatory submissions by incorporating relevant information, avoiding addition of superfluous information that hinders ease of managing changes during post approval (lifecycle management).
Instituted improvements in “change control system” by developing a “Grid” in trackwise that allows efficient execution of regulatory assessments of a “change”, impacting multiple products, in global markets, based on specific country regulatory requirements.
Developed processes to allow continuous monitoring of all IND/NDA annual reports, post approval submission and global quality/regulatory commitments to health authorities.
Established Growth & Development programs: Managed to establish current quality and regulatory expectation, encouraged development of specific skill set and regulatory knowledge via internal & external training. Continued to work by directing reports, providing 1:1 coaching, and knowledge sharing in manufacturing, quality and regulatory operations.
Chaired personnel “Growth and Development Programs” by establishing a forum, where SME on various quality/regulatory “subjects” were identified and presentations were given to improve knowledge and understanding of QA/RA guidelines and sciences.
Developed training guidance (TG)/SOP working with all Forest mfg/packaging sites to allow making changes through Trackwise manageable at site level (level I changes), thus not overwhelming the system unnecessarily, while still maintaining compliance.
EXECUTIVE DIRECTOR OF QUALITY R&D AND COMMERCIAL MANUFACTURING (EXTERNAL MANUFACTURED PRODUCTS) [Jan 2007- Nov 2009]
Established partnerships with global CMOs/CROs building quality systems to allow sustainable compliance status with domestic and foreign regulatory agencies.
Represented quality as part of Forest Global Supply Chain, providing strategic guidance on all quality issues, to optimize product supply and order fulfillment.
Established global corporate auditing group harmonizing quality and compliance standards. Formalized such commitments with business partners through Quality and Supply Agreements.
Instituted procedures to efficiently/effectively process review of QA/QC documentation by clearly defining acceptance/rejection criteria and collaborating with Regulatory Affairs team to assure commitments submitted in our regulatory dossiers are fulfilled.
HEAD OF QUALITY OF FOREST LABS LONG ISLAND OPERATIONS [Dec 2005 – Jan 2007]
Responsible for facilities at Inwood, Farmingdale, Commack, Hauppauge (R&D) - New York
Handled a group of 75 personnel (QA/QC).
SENIOR DIRECTOR OF QA/QC Inwood and Farmingdale sites [2003- 2005]
SENIOR DIRECTOR OF QUALITY ASSURANCE Inwood site only [2001- 2002]
Managed all GMP/PAI inspections at all Forest sites and responses to any compliance observation reported by global health authorities. Demonstrated successful inspection record with our customers and global health authorities.
Established a Quality Review Committee: A forum used to address all “Quality” related issues, working in collaboration with other business partners in Operations, Technical Services, Engineering, Regulatory and Quality Operations.
Established the “trackwise program” at all Forest sites, incorporating various modules i.e. complaints, deviation, CAPA, auditing and change control. This system allowed control and sustainable compliance regiment within the Forest organization.
In terms of our PAT (Process Analytical Technology) initiative, I managed to eliminate several redundant (non–value) “1st run dissolution testing” on products manufactured at our Inwood plant. This led to a total savings of about 2.5 -3 million dollars per year and a significant reduction in cycle time on batch release. Other projects initiated as part of such scheme were the use of Ion Mobility Spectroscopy for cleaning validation, and the NIR (near Infra-Red) for raw material Identification.
Established a Quality Partnership Program with our suppliers of raw materials and packaging components. Wrote the first Quality Agreement between Forest Labs and our suppliers. This template has now become the “Quality Agreements” standard used by the Forest Corporate Quality Organization. Executed Qualification of API sites both domestically and internationally. Performed due diligence audits of prospective business partners within a range of product types that included aerosol products, soft gel caps, gum products, ophthalmic, creams and ointments.
Instituted the 18 "Quality Systems" as part of our goal to attain sustainable compliance at all Forest sites.
Introduced concepts on 21st century risk-based initiatives as per FDA:
oInitiated a Quality Improvement Program. This entailed the following:
oIdentified redundancies in the manufacturing and packaging systems and eliminates them through procedural or system improvement.
oStudied cycle time and other Metrics covering our entire “Supply Chain Management cycle,” from procurement of raw material through distribution of packaged product.
oUsed Quality indicators (metrics) to study process efficiencies and provide solutions to reduce cycle times and improve order fulfillment.
oUsed Pareto Charts and Oshikawa fishbone schemes as tools to address some Quality issues (root cause analysis).
oCreated Product Quality Manual and Site Validation Master Plan.
oIntroduced concepts of lean manufacturing.
WATSON PHARMACEUTICALS INC., Copiague, NY, [1991- 2001] 10 years
SENIOR DIRECTOR OF QUALITY OPERATIONS [1995 – 2001]
DIRECTOR OF QA/QC [1993- 1995]
MANAGER OF QUALITY ASSURANCE [1991-1993]
Bolar Pharmaceutical Company, Inc., a 150-million-dollar manufacturer of proprietary (NDA) and generic (ANDA) solid dosage form drug products, shut down by the FDA in 1990 during the generic product scandals. Hired to Rehabilitate Bolar in 1991, and establish Pharmaceutical system to meet FDA requirements. The company changed its name to Circa from 1993-95. In 1995, Circa was acquired by Watson Pharmaceuticals / Actavis and now Allergen.
Handled interactions with governmental agencies and customer representative during audits and inspections; Handled all ADR’S and Complaints; Review and Approval of Raw materials, in process and Finish product; Control of State Board of Pharmacy licenses; Handled destruction of waste and plant safety; Conducted investigation on cGMP deviation via incident reporting systems; Annual product review and trend analysis; Designed and implement process, equipment and cleaning validation protocols.
Developed and implemented a comprehensive Rehabilitation program. The FDA approved the completed program and declared Bolar the 1rst rehabilitated generic Pharmaceutical Company.
Established and implemented a Master Validation Plan covering the entire Pharmaceutical system including: Analytical methods, processes, equipment, facilities and computer validation.
Contributed extensively in writing Chemistry, Manufacturing and Controls documentation for IND, NDA, ANDA and DMF’S in preparation for FDA submission.
Completed several pre-approval inspections for NDA and ANDA products. Based upon satisfactory compliance status, FDA had given waiver on pre-approval inspections on filed submission. Underwent several successful MCA (Medicines Control Agency) inspections for EU fillings.
Established Product development report system, linking bio-batches to commercial process, thus characterizing the Robust Nature of Formulation. In current times these concepts are being covered under the QbD guidelines.
Established cGMP Training, Internal/External Auditing, Incident Report system, Vendor Qualification Program, Batch Record Review System, Process Validation schemes and Statistical Process Control (SPC).
Implemented regulatory compliance procedures in accordance with regulatory requirements from EPA, DEA, OSHA and waste management.
Developed systems for handling control drug substance Schedule II - IV, assuming full responsibility as New York State Supervising Pharmacist.
Established a metrology and instrumentation department with primary responsibility for maintenance and calibration of laboratory and plant equipment.
Played an integral role in setting up systems with respect to Contract Manufacturing.
Audited by numerous Pharmaceutical companies including big pharma, and consistently received acclamation on the standard operating procedures (SOP’s) and Validation system established.
MANAGER OF PRODUCT DEVELOPMENT, ELKIN-SINN, INC, Amityville, NY (Division of AMERICAN HOME PRODUCTS), [1988- 1991]
Developed 8 products with fifteen (15) various dosage strengths. Investigated new technologies and its application. Innovated and improved existing processes; Developed solid dosage forms using different processes, including many complex wet granulations, film coating and sustain release technology; execution of process, equipment, cleaning validation on clinical and stability support batches manufactured for submission; Summarized CMC Section for ANDA submissions; Coordinated activities between Regulatory Affairs, Manufacturing, Quality Control\Assurance, Analytical Support, Sales and Marketing groups.
R&D CHEMIST (PHARMACEUTICAL ANALYSIS), VISION PHARMA INC, Brooklyn, NY, [1983 - 1988]
Coordinated Methods Validation program and General trouble shooting; Executed Pharmaceutical Analysis using various spectrophotometric techniques (UV/VIS, IR, AA) along with HPLC, TLC and GC Technology. Responsible for coordinating analytical testing activities to support Product Development programs; Development of Test Specifications; Pharmaceutical analysis of Raw Materials, In-process and Finish Dosage for Overall Regulatory Compliance, including waste management.
Regulatory Affairs Certification (April 2009) RAC from RAPS
M.S. INDUSTRIAL PHARMACY - May 1988 - St. John’s University, College of Pharmacy, Jamaica, NY
BSc Chemistry and Management (Double Honours Program) - June 1983- University of London, Queen Elizabeth College, London, United Kingdom
Attended Several Seminars on Regulatory CMC submissions, Pre-Approval Inspections, Validation, Auditing etc.
Given Presentations on Pre-Approval inspections and cGMP Compliance, Regulatory CMC filing strategies, Change Control and FDA inspections.
Regulatory Affairs Professional Society (RAPS)
American Association of Pharmaceutical Sciences (AAPS)