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!