Quality Control Regulatory Affairs
Resume:
Rajeev John
** ******** *** ***** *********, NJ *8902
Email - ************@*****.***
SUMMARY
A highly motivated, fast track professional with over 12 years of Regulatory Operations Submissions Management experience 15 years of Clinical Drug Development with strong multi-functional regulatory, clinical and quality control and assurance background. Extensive managerial and mentoring experience. Demonstrated ability to expand beyond the scope of the assigned responsibilities to gain proficiency in new areas.
Primary responsibilities have been focused on preparation/submission/project management of regulatory affairs submissions/operations to global health authorities. These responsibilities have ranged from development of submission documentation to assisting in the process of preparation for response to queries from various agencies, maintaining INDs, NDAs, ANDAs, Type 1, Type 2, BLAs’s, IMPDs, IND Amendments, DSURs, PSURs and Technology Transfer submissions for global regulatory authority submissions. Managing publishing teams to achieve the highest quality submissions with a 98% success “right the first time” approach. Building efficiencies in document publishing processes. Working with multiple functional teams (regulatory, clinical, data management, quality assurance, quality control, manufacturing sciences, product quality experts and regulatory operations). Streamline process and develop timelines, milestones, interdependencies, risk management, bottle necks, rate limiting steps and required actions, corrective action plans.
Successfully researched, reviewed, validated, and migrated multiple regulatory authority submissions and documentations from local file share to electronic document management systems. Maintained and managed documentation in archiving systems for over 12 different INDs from NA, LATAM, EU, APAC regions.
As a seasoned Regulatory Operations Submission Manager, I gain comprehensive understanding of the organization’s operations models and methodologies, and am able to provide solutions and support of services. As Program Director/ Client Engagement manager i have provided a full range of consulting services and work within my personal area of expertise (Regulatory Affairs and Operations). Provide SME experience, mentoring and guidance to junior team members on technical and/or business issues and support knowledge-centered activities. Provide viable scenarios to clients that work within budget and regulatory authority constraints.
SKILLS
Industry
●In depth knowledge of document Submissions Management processes and Drug Product Development for all health authority related documentation from change control management to publishing and working with LOCs for local submission. Working knowledge of Veeva vault and other document based RIM systems. Detailed knowledge of CMC documentation process and submission guidelines and ECTD backbone structure.
Working knowledge of all module submissions.
●In depth knowledge of Regulatory Affairs Drug Development processes - I have worked in various Regulatory technologies, and am trained as a subject matter expert in Regulatory Submissions processes in the US, Canada, EU and Asia Pacific.
●In depth knowledge of eCTD submissions format, folder structure, publishing tools (ISI toolbox, eCTD express, Insight Publisher, Lorenz Validator, Rosetta Pyramid Viewer, Veeva Submissions Vault, First Doc., Please Review, SHEDs, Mosaic and have been trained in and given training on multiple homegrown document management systems like SHEDs. Detailed knowledge of publishing processes for US, EU EMEA, Health Canada, Caribbean, South America, China, Korea and Japan
●In depth understanding of Cosmetics Regulatory process and development – I have worked with US FDA submissions of Cosmetics and Skincare products. I have very good experience on submitting dossiers, APRs to health authorities globally.
●In depth understanding of clinical business processes, study design, and the life cycle of studies from startup, development and post marketing.
●In Depth understanding of (FDA and PMDA) regulatory requirements, including CFR 21, signature requirements, and security requirements for electronic media. Proficient in GMP, GCP, GXP guidelines as mandated by Health Authorities.
●Have the expertise to work with the end user customers and technical teams with ease, and translate customer requirements to provide workable solutions using the available systems / technologies
●Proficient in all MS office Suite products (Word, Excel, PowerPoint, Project, Access, Outlook, etc.)
●Worked with and familiar with various RIMs, eTMF, SharePoint, iCloud, AWS, e-Scanning, etc.
Teamwork & Relationships
Ability to handle multiple tasks with rapidly changing priorities and deadlines, with full attention to detail
Experience working in a regulated, documented environment.
Client focused approach with excellent organizational and time management skills.
Self-motivating, can take responsibility and work autonomously in a professional manner.
Worked in matrix envoirnment
Lead teams to success, provide feedback and mentoring / employee development
Proven success in developing strategy and solutions for clients.
Prior experience in building successful partnerships, building and scaling up teams for projects
Management
Excellent interpersonal skills and an ability to build strong working relationships
Line management and people management experience with very large teams, experience in managing offshore and global teams
Effective oral and written communication skills, can present at all levels
Work globally across time zones, and cultures. Can work within a global client business environment with ease
Experience managing multiple projects and leading projects
Experience with working on tight timelines, issue resolution, interdependencies, risk management, corrective action and planning
PROFESSIONAL EXPERIENCE
12/5/2023 – 5/30/2024
Immunovant Inc.
Associate Director, Program Management (RFT) (Contract)
Responsibilities include Work closely with the Rapid Filing Team (RFT) and act as the liaison between members of submissions and other functional areas in order to ensure timely submission of regulatory-compliant, quality documents. Interpret, implement, and ensure compliance with relevant revised and new FDA/ICH regulations to meet company deadlines. Have direct impact on the company's ability to meet goals and timelines related to CTD to CTR submissions; identify and escalate issues which may impact submission timelines and goals. Coordinate core documentation activities. Develop and maintain best practices for the Submissions Group consistent with evolving FDA guidelines for electronic submissions. Provide support to Regulatory Affairs, Clinical Operations and Reg. Strategy and other project stakeholders in the creation of submissions documents. Work collaboratively and efficiently with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations
03/01/2023 – 06/02/2023
Moderna Therapeutics, Inc.
Regulatory Consultant (Short Term Contract)
Responsibilities included being able to help designate specific documents, where they need to go and ensure a smooth process. Work with various teams in Regulatory Affairs, Chemistry and Manufacturing sites to drive submissions to completion. Setting up, conducting Kick off meetings and setting up timelines for submissions. Assist with various aspects of the submission while lesioning with integral team members to ensure a smooth process. Mainly working with large molecule and Oncology products and Rare Disease products. Lifecycle maintenance of Applications. Good working knowledge of GMP, GCP, GXP guidelines that were used in day-to-day activities as pertaining to drug development processes.
12/09/2019 – 12/23/2022
Takeda Pharmaceuticals Inc.
Regulatory Operations Manager/ Submissions Management (Contract role)
Responsibilities included planning and tracking for regulatory submission activities for the assigned product/project, ensuring appropriate stakeholder engagement and participation. Support operational excellence for CMC sections and other modules for regulatory submissions by adhering to and applying established processes and tools. Day-to-day management of regulatory submissions, including preparation for and leading of meetings, document manipulation and routing for authoring and review, etc. Provide guidance for submission eCTD granularity and global submission requirements. Enable high quality documents through content review and compliance to submission ready standards. Develop and maintains strong communication and collaboration with the stakeholders. Be proficient on the EDMS system and provides support to end users to ensure effective utilization of document management systems.
05/29/19 – 8/30/19
Daiichi Sanyko, Ltd., Basking Ridge, NJ
Manager, Document Excellence- Regulatory Operations (Contract role)
As a Manager, Document Excellence department, it was my responsibility to manage the evaluation of processes to ensure organizational responsibilities are met with the highest degree of quality and timeliness for regulatory and clinical documents. Coordinate and oversee the document assembly/production process and structural organization of regulatory documents. Identify, plan, and manage general business process improvement opportunities. Lead/drive in the development of business processes with internal and external partners. Liaise with cross-functional DS groups to develop processes for document preparation and transmission for inclusion into submissions. Establish and maintain effective timely communication across Regulatory Operations including Regulatory Affairs and Clinical Development Operations. Manages document tactical activities. Communicate and actively collaborate with managers and leaders concerning the document process; assists in creating, communicating, and implementing organizational goals and objectives. Train personnel in regulatory document preparation, review, and publishing and planning activities ensuring compliance. In collaboration with leadership may help to conduct departmental meetings. Demonstrate an expert understanding of document preparation process and role of each contributing discipline. Attend and lead (when appropriate) the document preparation team meetings. Oversee & maintain document planning issue log and begin assuming more responsibility with document planning. Take leadership role in facilitating Specialist initiatives/meetings. Regularly lead functional meetings with internal/external contributors.
11/20/16 – 02/06/19
Cognizant Technology Solutions, Bridgewater, NJ
Delivery Lead, Global Regulatory Operations (Permanent role)
As a Delivery lead my responsibilities included but were not limited to first point of contact for client regional lead and for Hub related queries. Working in close collaboration with the Head of Global Submission Publishing and Global Submission manager, assigned to respective franchise/activity with clear accountability for publishing process, Develop/adopt & implement best practices for producing & maintaining high quality deliverables, liaising with a team of Publishers located globally. Working in a global capacity with colleagues across these regions, providing strategic and operational expertise to teams for routine or maintenance submissions to ensure the timely, quality preparation and execution for electronic and paper submissions to Global Health Authorities (EU, US), Ensure country-specific regulatory requirements, as provided by client, are assimilated into teams and processes. Facilitate weekly review meetings for progress, metrics, escalation, training, resourcing
●Establishes new processes including documentation and perform QC work through spot checks, as needed.
●Create and maintain regulatory affairs documents like QCP, SWI as applicable for all aspects of Regulatory affairs
●Provide inputs as a SME to operations team as and when required
●Monitor the quality of deliverables, identify potential risks and mitigate them in advance and raises concerns and issues to the Engagement Manager proactively.
●Excellent leadership and people management skills with customer focus and attention to detail
●Ability to prioritize work and manage multiple projects and tasks
●Interaction with stakeholders and client through emails, and telephonic conversations, maintenance of proper communication channels, ensuring updates are getting percolated in the team
●To ensure timely deliverables & their adherence to SLA's by maintaining a tracking mechanism
●Monitor the progress at all phases (i.e. from training, mocks & the live work) and ensure smooth operations
4/2014 – 10/1/16
IMEDGlobal Inc., Princeton, NJ
Client Engagement Manager/Regulatory Practice Lead (Permanent Role)
As a Regulatory Practice Lead it is my responsibility to work with project teams, vertical team leads and other cross functional teams to seamlessly advance the acquired project through regulatory processes (submissions, reviews, agency response, and filing) and provide Regulatory oversight where needed.
●Respond and defend RFPs and Customer Surveys for new client bids along with Sales team.
●As a SME in Regulatory Affairs, present the services portfolio to new clients at meetings and bid defenses. ( presented to J&J group of companies, Novartis, Reckett Benckiser, Prizer, Sanofi Aventis)
●Develop and implement regulatory strategy for assigned drug development candidates and/or marketed products, including OTC labeling team.
●Interact with FDA and other international regulatory agencies globally on a proactive, independent and frequent basis.
●Communicate company views to regulators and maintain effective, professional relationships with regulatory agency officials.
●Provide direction for assigned programs by coordinating all aspects of regulatory submissions and responses and regulatory management of the products over all life-cycle.
●Represent regulatory affairs on internal and external project teams, provide advice to project teams and line departments on regulatory requirements guidelines and strategy.
●Work collaboratively with Regulatory Affairs colleagues in CMC and Operations, etc. to ensure integrated, well-coordinated approaches to planning regulatory submissions and responses and development solutions to regulatory issues.
●Manage the timely preparation and submission of INDs, NDAs and BLAs (and corresponding international registration packages) amendments/supplements, variations to these applications and respond to regulatory agency questions.
As a Client Engagement Manager, it was my responsibility to work with key stakeholders, opinion leads and project owners to ensure that client work is performed, and delivered on time; meeting the quality expectations of Regulatory Outsourcing and the client.
●Develop and support a Center of Excellence for Regulatory processes for J&J OTC / Consumer Products group where business grew from $1.7 Million to $11.8 Million over 2.5 hear period.
●Focused on finding solutions to problems, developing and standardizing processes, strategizing with ways to better streamline and drive efficiency.
●Oversees projects and project teams; be responsible for leading those team
●Work with labeling team in the OTC market to review label tracking system and build efficiencies in the system
●Manage client expectations on project enrollment and business continuity. Working with offshore delivery centers to ensure a high level of resource allocation for each assigned project. Fulfillment of over 200 resources onboarded on a project for various disciplines and work streams.
●Meeting and developing a program plan/project charter with clients to enhance the project requirements and provide a high level of service for each project.
●Help develop new business, support proposal writing and request for Information proposals for new business ventures.
4/11-8/31/12
ImClone Systems, Inc., Bridgewater, NJ
Associate Director, Regulatory Operations (Long Term Contract)
During my experience at ImClone Systems I researched, reviewed and recommended a document management system for the company to migrate store and manage their regulatory document archives from a file share into a robust, secure and user friendly system. I managed the migration of regulatory documents of 12 active oncology compounds into the document management database system. I managed the archiving requests from other company functions and provided advice to Regulatory Liaisons and Submissions Management team to ensure consistent filing and retrieval for all health authority documents from repository. I oversaw that all requests for archiving were completed and closed according to written procedures. I created metrics reports and used metric reports to identify trends and needs for staff training. I managed collaboration with Regulatory Liaisons to ensure that archive requests in support of audits were reviewed and provided to ImClone contacts prior to being sent to health authorities or internal/external inspectors and auditors.
•Responsible for managing and coordinating new archiving application systems with vendors, QA document management repository, IT, and Eli Lilly.
•Responsible for managing the implementation activities, training, documenting new processes, and participation in repository software validation.
•Responsible for managing the Regulatory Repository (paper and electronic systems) by properly storing and retrieving documents in a timely manner according to processes and procedures.
1/2011 – 4/2011
Johnson & Johnson, Skillman, NJ
Regulatory Affairs Consultant (Short-Term Contract)
8/2008 – 8/2010
Sopherion Therapeutics, LLC, Princeton, NJ
Senior Manager, Regulatory Affairs (Permanent Position)
1998 – 2008
Sanofi-Aventis Inc., Bridgewater, NJ
Transverse Regulatory Coordinator – (Short-Term Contract)
PharmaNet, Inc, Princeton, NJ
Regulatory Affairs Consultant – (Long-Term Contract)
I3 Research, Basking Ridge, NJ
Senior Regulatory Affairs Associate – (Permanent Position)
Winthrop University Hospital Clinical Trials Network Mineola, New York
Office/Regulatory Manager - (Permanent Position)
EDUCATION
Bachelor’s in Applied Life Sciences – Pending Completion
Grand Canyon University
High School Graduate - 1986
Mt St. Michaels Academy -NY-Bronx
REFERENCES
Available Upon Request
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