Job Description: We are inviting applications for the role of Senior Manager, Regulatory affairs.
Responsibilities:
•       Develop global regulatory strategy for lifesaving therapeutic products in development and through life cycle management considering all relevant guidance, commercial needs, and company objectives.
•       Develop global or US regulatory strategy for therapeutic products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives.
•       Develop strategic direction and provide leadership for all regulatory interactions with FDA/EMA and global regulatory authorities.
•       Lead regulatory dossier submissions to FDA (IND, BLA, NDA, and supplements), MAA (EU) utilizing internal and external stakeholders; ensure appropriate quality controls in place for compliant submissions.
•       Writing regulatory documents (e.g. new BLA/NDA/INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed.
•       Provide strategic direction (and content input) on US Labeling
•       Anticipate and interpret key trends and changes in the EMA/US regulatory environment and provide strategic guidance regarding development plans as a result.
•       Foster positive relationships with FDA.
•       Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion & Compliance, Global Development, and other functions key to the success of product development.
•       Interact routinely and will develop a strong team environment with colleagues throughout GRS.
•       Responsible for implementing CMC regulatory strategies for assigned Biologics specifically for cell gene therapy in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers
•       Ability to lead client meetings and managing project governance.
•       Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
•       Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
•       Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
•       Demonstrated ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
•       Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
•       Demonstrated effective leadership, communication, and interpersonal skills.
•       Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals.