Senior Director Regulatory Strategy

Location:

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Pennsylvania (Hybrid)  

Contract Type: 12-Month Contract (Urgent Start)

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About the Role:

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We are seeking a highly experienced Senior Director of Regulatory Strategy to join a leading pharmaceutical company in Pennsylvania on a 12-month contract. This role is urgent, requiring an individual who can step in quickly to provide strategic leadership in regulatory affairs, ensuring compliance with FDA and global regulatory requirements.

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Key Responsibilities:

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• Develop and implement regulatory strategies to support product development and commercialization.
• Lead interactions with the FDA and other global health authorities, including submission of regulatory filings (INDs, NDAs, BLAs, etc.).
• Provide regulatory guidance to cross-functional teams, including clinical, CMC, and commercial teams.
• Oversee the preparation and submission of regulatory documents, ensuring accuracy, quality, and compliance.
• Monitor regulatory trends, changes in guidelines, and industry best practices to proactively adjust strategies.
• Manage regulatory timelines and ensure alignment with business objectives.
• Serve as a subject matter expert on regulatory affairs, advising senior leadership on potential risks and opportunities.

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Qualifications & Experience:

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• 10+ years of regulatory affairs experience within the pharmaceutical or biotech industry.
• Proven track record of successful interactions with the FDA and other regulatory agencies.
• Strong experience with IND, NDA, BLA, and other regulatory filings.
• In-depth knowledge of global regulatory requirements, including ICH guidelines.
• Experience working in a fast-paced, high-stakes environment with urgent timelines.
• Excellent leadership, communication, and negotiation skills.
• Advanced degree in life sciences, regulatory affairs, or a related field preferred (Ph.D., PharmD, or MS a plus).