Director Regulatory Affairs Strategy

Job Description

Job Description

Our Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants.

• Lead/support Regulatory Affairs Functional Teams (RAFTs) to ensure the highest quality strategic regulatory input is provided to optimize regulatory outcomes and maximize product value.
• Lead developing and creating global / regional regulatory strategies for multiple clinical development projects at all stages (Phase 1 through market authorization).
• Author and / or review regulatory documents for submission to US and/or Rest of World regulatory agencies in support of formal meetings with health authorities and major applications (INDs / CTAs, NDAs / BLAs, MAAs, orphan, etc.)
• Provide leadership and strategic input to the Filing Submission Team and lead other project sub-teams, as assigned.
• Lead the preparation for and conduct of formal meetings with regulatory health authorities including the review of applications and negotiations with Health Authorities.
• Provide on project teams or management committees regulatory expertise/advice on requirements for pre-clinical, clinical disciplines, as well as companion diagnostics, in support of drug candidates under development.
• Create and maintain Regulatory Strategic Development plans and provide strategic input to global project development plans.
• Identify and escalate potential Regulatory issues to executive management and propose risk evaluations and mitigation strategies.
• Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations as needed.
• Research regulatory requirements to support submissions or inquires from functional groups.
• Remain current on changes in regulatory requirements and environment and be a resource to function groups for regulatory information.
• Prepare and reviews SOPs / WIs to achieve consistency in regulatory standards and compliance.
• Assure that all aspects of the Company’s regulatory activities are conducted in full compliance with application regulations and at the highest level of ethical standards.

• Ph.D. or PharmD degree
• 5-10 years Regulatory Affairs experience
• Strong experience in Regulatory Strategy
• Must have led or currently leading an NDA or BLA filing
• Must have led or currently leading the strategy and authoring of a study plan, i.e., pediatric study, etc.
• Must have led or currently leading label negotiations
• Must have led the preparation of Briefing Documents for milestone meetings