- 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
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Director, Medical Affairs Strategy
1 week ago
GENMAB A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
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Director Regulatory Affairs Strategy
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Lynkx Staffing LLC Princeton, United StatesJob Description · Job DescriptionOur 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 co ...
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Director, Regulatory Affairs Strategy
5 days ago
Genmab Princeton, United StatesJob Description · At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people ...
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Director, Regulatory Affairs Strategy
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Genmab A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
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Director, Global Medical Affairs Strategy
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GENMAB A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
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Director, Global Medical Affairs Strategy
5 days ago
Genmab Princeton, United StatesJob Description · At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people ...
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Director, US Medical Affairs Strategy
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Senior Director, Regulatory Affairs Strategy
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Genmab A/S Princeton, NJ, United StatesThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at . · Director, Global Medical Affairs Strategy - Solid Tumors page is loaded · Director, Global Medical Affairs Strat ...
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Director, Global Medical Affairs Strategy
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Senior Director, Regulatory Affairs Strategy
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Genmab Princeton, United StatesThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at · . · Senior Director, Regulatory Affairs Strategy page is loaded · Senior Director, Regulatory Affairs Strategy · A ...
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Bristol Myers Squibb Princeton, United StatesWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
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Meet Trenton, United StatesWe are partnering with a growing biotech that is seeking a highly skilled and experienced Associate Director of Regulatory Affairs Strategy to join our Regulatory Affairs team. The successful candidate will play a pivotal role in developing and executing regulatory strategies to ...
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Meet Recruitment Trenton, United StatesWe are partnering with a growing biotech that is seeking a highly skilled and experienced Associate Director of Regulatory Affairs Strategy to join their Regulatory Affairs team. The successful candidate will play a pivotal role in developing and executing regulatory strategies t ...
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Regeneron Pharmaceuticals, Inc Bernards, United States Full timeThe Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so res ...
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Bristol-Myers Squibb Princeton, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
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Bristol-Myers Squibb Princeton, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
Director Regulatory Affairs Strategy - Princeton, United States - Lynkx Staffing LLC
