Director of Regulatory Affairs
Title: REMOTE Director, Regulatory Affairs - U.S. Team Lead
Overview:
A growing life sciences organization is seeking a seasoned regulatory leader to oversee U.S. regulatory operations. This position will manage the U.S. regulatory affairs team and collaborate with global and cross-functional partners to ensure successful product development and commercialization within the regulatory landscape.
Key Responsibilities:
- Develop and implement U.S. regulatory strategies aligned with corporate objectives.
- Lead all regulatory activities across the U.S. portfolio, ensuring timely and compliant submissions.
- Lead regulatory agency interactions and support the planning and execution of meetings with U.S. health authorities.
- Oversee the preparation and submission of regulatory filings for new and existing products.
- Identify and mitigate regulatory risks across the product lifecycle.
- Provide leadership on regulatory review for product labeling, advertising, and promotional materials.
- Act as regulatory subject matter expert for commercial materials and contribute to promotional review committees.
- Ensure compliance with promotional submission requirements and maintain related documentation
- Monitor evolving U.S. regulatory requirements and assess potential impact on current and future products.
- Support global regulatory alignment by maintaining compliant regulatory and technical content across filings.
- Keep current on regulations governing advertising, promotion, and CCDS; communicate critical updates to internal teams.
Qualifications:
- In-depth knowledge of U.S. FDA regulations and guidance.
- 10+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, including 5+ years focused on advertising and promotion.
- Bachelor's degree in a relevant scientific discipline; advanced degree
- Prior team management experience.
- Exposure to medical device regulatory environments is a plus.
Benefits:
- Generous PTO and leave policies.
- Comprehensive health and wellness benefits.
- Annual bonus potential.
- Competitive retirement plan offerings
- And more!
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