Global Director Regulatory Affairs Strategy
2 days ago
Job Description:
At Lynkx Staffing LLC, we are seeking a highly skilled Global Director Regulatory Affairs Strategy to lead our global teams in the development and execution of regulatory strategy.
Key Responsibilities:
* Lead Regulatory Affairs Functional Teams (RAFTs) to ensure high-quality strategic regulatory input is provided to optimize regulatory outcomes and maximize product value.
* Develop and create 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.
* Prepare for and conduct formal meetings with regulatory health authorities, including the review of applications and negotiations with Health Authorities.
* Provide 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 review SOPs/WIs to achieve consistency in regulatory standards and compliance.
Requirements:
* 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
Why Lynkx Staffing LLC?
At Lynkx Staffing LLC, we are committed to providing our clients with the highest quality talent and expertise. We believe that our Global Director Regulatory Affairs Strategy will be a valuable addition to our team and contribute to our mission of delivering exceptional results.
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