Regulatory Advertising & Promotion Consultant (Part-Time, Remote, Interim Role)
We are seeking an experienced Regulatory Advertising & Promotion Consultant to provide temporary support on an as-needed basis.
Key Responsibilities
- Review and approve promotional materials to ensure alignment with FDA regulations, guidance, and enforcement activity.
- Actively contribute to Promotional Review Committee meetings, offering strategic regulatory insight on marketing concepts, campaigns, and labeling.
- Prepare and submit Form 2253 filings to the FDA in accordance with regulatory requirements and timelines.
- Stay abreast of FDA enforcement trends and evolving regulatory guidance; communicate relevant updates to internal stakeholders.
- Partner with cross-functional teams—including Legal, Medical Affairs, and Commercial—to address regulatory questions and provide clear, actionable guidance.
- Ensure all promotional review documentation is accurately maintained in Veeva PromoMats.
Qualifications
- Bachelor’s degree required; an advanced degree (e.g., PharmD, JD, PhD, or Master’s in life sciences) is highly preferred.
- 10–12+ years of regulatory experience in the pharmaceutical or biotech industry, with a minimum of 8 years focused on promotional review for prescription drugs or biologics.
- In-depth knowledge of FDA promotional regulations, relevant guidance documents, and enforcement practices.
- Prior experience with Veeva PromoMats strongly preferred.
- Demonstrated ability to work independently, manage multiple priorities, and meet deadlines with minimal oversight.
- Excellent written and verbal communication skills, with a strong ability to influence and collaborate across teams.
- Comfortable working in a fast-moving, evolving environment.
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