Associate Director, Regulatory Affairs
New
J
JobgetherBiopharmaceutical
Remote work arrangement within the United States.Full-TimeDirector
Salary$164,000–$225,500 USD
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Job Details
- Experience
- Minimum 8 years of regulatory affairs experience within biopharmaceutical organizations, including 3–5 years in global leadership roles with a strong FDA focus.
- Required Skills
- Project Management
Requirements
- Minimum 8 years of regulatory affairs experience within biopharmaceutical organizations.
- 3–5 years in global leadership roles with a strong FDA focus.
- Thorough understanding of the drug development lifecycle, with expertise in orphan drugs.
- Demonstrated experience coordinating critical regulatory documentation supporting FDA-focused submissions.
- Proven experience interacting directly with regulatory authorities.
- Strong understanding of current and emerging regulatory legislation and industry trends.
- Highly developed organizational and project management skills.
- Strong communication and presentation capabilities with the ability to influence stakeholders.
- PhD or PharmD preferred.
- Familiarity with digital technologies, AI-enabled tools, and data-driven approaches.
Responsibilities
- Develop and implement robust US regulatory strategies for assigned development and commercial projects.
- Provide strategic, operational, and tactical regulatory guidance across pre-approval and post-approval activities.
- Serve as a primary point of contact with the FDA and lead regulatory meetings.
- Lead and oversee the preparation of regulatory dossier content for INDs, BLAs, and NDAs.
- Coordinate timely responses to FDA questions in alignment with product and regulatory strategies.
- Partner with clinical, medical, legal, quality, and pharmacovigilance teams to inform business decisions.
- Monitor, interpret, and communicate changes in the US regulatory environment and legislation.
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