Associate Director, Regulatory Affairs Strategy

10 Nov, 2020


Associate Director, Regulatory Affairs Strategy

Kyowa Kirin
Princeton, NJ

Provide regulatory leadership, strategy and tactical support for assigned investigational projects; represent Regulatory Affairs on global project development teams and management committees; remain current on regulatory requirements for relevant countries, particularly US and Canada; demonstrate excellent interpersonal skills and the ability to prioritize multiple tasks.

To be given immediate consideration, you:

-Must have led or currently leading an NDA or BLA filing from a content perspective (publishing not ideal)

-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

Global/Regional Regulatory Leader on assigned products

• Lead/support Regulatory Affairs Funtional 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.

**Candidates commutable to the Princeton, NJ area are preferred as relocation assistance will not be offered at this time**

Learn more here

Job posted: 2020-11-10