Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee regulatory compliance for advertising, promotion, medical communications, and product labeling from the planning stages of product launch through its entire lifecycle.

• Formulate and implement regulatory strategies for product communications and core labeling.

• Ensure that all commercial and non-promotional materials, core labeling, and local product labeling are in accordance with US FDA, EMA, and other pertinent global regulations.

• Act as the regulatory lead for promotional and medical review committees.

• Offer risk-based advice regarding claims, supporting evidence, fair balance, and multichannel communications.

• Guide the creation of promotional, advertising, and educational materials across various platforms including print, digital, social media, speaker programs, and formulary communications.

• Lead interactions with the US FDA's OPDP and, when necessary, APLB.

• Collaborate with Global Regulatory Leads to negotiate labeling with Health Authorities.

• Oversee the development and maintenance of core, U.S., and patient labeling.

• Establish and enhance review processes, Standard Operating Procedures (SOPs), systems, and training programs.

• Keep track of regulatory guidance, enforcement trends, competitive landscape, and new safety and efficacy data.

• Develop and implement global labeling execution plans.

• Manage vendors as well as budgets and resources effectively.

• Collaborate with Commercial, Medical Affairs, Legal, and Compliance teams.

• Willingness to travel approximately 20% of the time.

• Reports directly to the SVP, Chief Regulatory Officer.

⛳️ Requirements

• Bachelor’s or Master’s degree with relevant experience.

• At least 8 years of regulatory experience in the biopharmaceutical sector, including a minimum of 6 years in advertising and promotion or a similar field.

• Proficient in FDA promotional regulations, labeling, MLR review, promotional submissions, and interactions with OPDP.

• Proven experience in product launch and lifecycle management.

• Strong leadership, scientific judgment, communication, and project management abilities.

• Familiarity with Veeva PromoMats or comparable systems.

• Excellent interpersonal and communication skills, both written and verbal.

• A track record of providing innovative solutions to Commercial and Medical Affairs teams, demonstrating sound judgment and a realistic perspective on challenges.

• Advanced degree in life sciences or medicine (MD, PhD, PharmD) is preferred.

• Experience in growth-stage biotech is an advantage.

🏝️ Benefits

• Eligibility for annual bonuses.

• Equity options.

• Comprehensive benefits package.

• Participation in the Company’s stock plan.