Director, Regulatory Affairs – Advertising and Promotion

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

📋 Description

• Act as the Chair of the Materials Review Committee, offering regulatory expertise for promotional materials, medical communications, and payer communications.

• Serve as the main liaison with the FDA (OPDP/APLB) and PAAB, addressing agency inquiries and overseeing requests for advisory review.

• Review and authorize Form FDA-2253 submissions.

• Offer strategic and operational regulatory guidance concerning concepts, campaigns, and product labeling.

• Assist U.S. and Canadian commercial and medical teams through strategic discussions and team meetings.

• Keep abreast of changing agency regulations, interpretations, advisory letters, enforcement letters, and policy trends.

• Inform relevant stakeholders of significant changes in agency perspectives.

• Lead cross-functional process enhancements or special projects as required.

• Represent the Regulatory Affairs Advertising and Promotion team at regulatory sub-team and labeling meetings.

• Provide strategic regulatory guidance and fulfill other necessary duties.

⛳️ Requirements

• A BA/BS degree is required; an advanced degree is preferred (PharmD, PhD, MS, MBA, JD).

• Over 10 years of industry experience, including more than 5 years in advertising promotion.

• Exceptional verbal and written communication abilities.

• Strong attention to detail and capability to manage multiple priorities effectively.

• Excellent interpersonal skills complemented by strategic and analytical thinking.

• Ability to promote transparent, collaborative, and respectful working methods.

• Experience in chairing or leading review committees or relevant regulatory governance committees.

• Proven experience in participating in cross-functional projects and teams.

• Strong comprehension of team dynamics.

• Veeva PromoMats experience is preferred.

• Willingness to travel as necessary.

🏝️ Benefits

• Generous vacation time along with public holidays recognized by the company.

• Volunteer days provided.

• Long-term incentive and Employee stock purchase plans or equivalent offerings available.

• Employee wellbeing benefits included.

• Fitness reimbursement offered.

• Tuition sponsorship available.

• Professional development plans in place.

• Annual bonus included.

• Equity incentives available.