Associate Director Regulatory Strategy
3 weeks ago
Title: Associate Director of Regulatory StrategyA rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development. Key ResponsibilitiesServe as the global regulatory lead for assigned development programs and marketed products, with primary ownership of drug-device combination product strategy and a collaborative role in clinical and nonclinical planning.Prepare and represent the company in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), with particular focus on CMC, clinical, and combination product matters.Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents-ensuring strategic alignment and technical rigor.Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling-particularly for injectable and inhalation drug-device combinations. This includes conducting change control impact assessments and preparing associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements.Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle management plans from early development through late-stage and post-commercialization activities.Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to ensure the organization remains at the forefront of combination product innovation. QualificationsBachelor's Degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a Master's Degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development.Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies).Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA).Familiarity with 505(b)(2) development strategies or innovative delivery platforms.Interest in mentoring or shaping regulatory frameworks in emerging therapeutic areas.Proven track record of successful interactions with the FDA and/or global regulatory agencies.Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies.Strong writing, communication, and leadership skills-with the ability to translate complex issues into actionable strategies.
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Associate Director Regulatory Strategy
3 weeks ago
Boston, United States EPM Scientific Full timeTitle: Associate Director of Regulatory StrategyA rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development. Key ResponsibilitiesServe as the global regulatory...
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Associate Director Regulatory Strategy
1 day ago
Boston, United States EPM Scientific Full timeTitle: Associate Director of Regulatory StrategyA rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development.Key ResponsibilitiesServe as the global regulatory...
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Associate Director Regulatory Strategy
3 weeks ago
Boston, MA, United States EPM Scientific Full timeAssociate Director of Regulatory Strategy A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy . This role will lead regulatory strategy for drug-device combination product development. Serve as the global regulatory lead for assigned...
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Associate Director Regulatory Strategy
3 weeks ago
Boston, MA, United States EPM Scientific Full timeTitle: Associate Director of Regulatory Strategy A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy . This role will lead regulatory strategy for drug-device combination product development. Key Responsibilities Serve as the global...
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Associate Director Regulatory Strategy
3 weeks ago
Boston, MA, United States EPM Scientific Full timeTitle: Associate Director of Regulatory Strategy All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description. A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy . This...
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Associate Director
4 weeks ago
Boston, United States Boston Staffing Full timeAssociate Director, Regulatory StrategyAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of...
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Associate Director
3 weeks ago
Boston, United States Eli Lilly Full timeAssociate Director, Regulatory StrategyAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of...
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Associate Director
1 week ago
Boston, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Director, Regulatory Strategy
5 days ago
Boston, United States Vertex Full timeJob DescriptionGeneral Summary:The Director, Regulatory Strategy will be responsible for the development and implementation of innovative global/regional regulatory strategies for assigned projects within the Vertex portfolio. This position will play a major role in shaping cohesive regulatory strategy for assigned program(s) and ensuring effective...
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Senior Director, Regulatory Strategy
7 days ago
Boston, United States Vertex Full timeJob DescriptionGeneral Summary:The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in...
