Regulatory advertising & promotional consultant

Regulatory Advertising & Promotional Consultant


Regulatory Advertising & Promotional Consultant

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Global Head of Contracting, Consulting and Outsourcing

Remote in Europe or USA

Overview:

We are seeking an experienced Regulatory Affairs Consultant specializing in Advertising & Promotion (Ad Promo) to support the review and approval of promotional materials and activities in compliance with FDA and other global regulatory requirements. This role will partner closely with Marketing, Medical Affairs, Legal, and Regulatory teams to provide guidance on advertising, promotional, and disease awareness materials.

Key Responsibilities:

* Serve as the Regulatory reviewer on promotional review committees (PRC or MLR).
* Review and approve promotional materials for healthcare professionals, patients, and consumers.
* Provide strategic and operational guidance on FDA (OPDP/CBER) and global advertising & promotion regulations.
* Ensure compliance with applicable laws, regulations, and industry guidelines (e.g., FDCA, 21 CFR Part 202, PhRMA Code, FTC, EMA).
* Advise on social media, digital campaigns, press releases, and other external communications.
* Maintain awareness of enforcement trends, FDA untitled/warning letters, and regulatory intelligence.
* Assist with submission of promotional materials to FDA (Form 2253, etc.).
* Participate in training and guidance for cross-functional teams as needed.

Qualifications:

* Bachelor’s degree in life sciences or related field (advanced degree preferred).
* 5+ years of Regulatory Affairs experience with a strong focus on Ad Promo.
* Experience supporting PRC/MLR reviews in a fast-paced environment.
* In-depth knowledge of FDA promotional regulations, with global experience a plus.
* Prior consulting experience or ability to work independently as a contractor.
* Strong interpersonal and communication skills to effectively partner with commercial teams.

Preferred:

* Experience with oncology, rare disease, or specialty therapeutics.
* Familiarity with Veeva PromoMats or similar promotional review systems.
* Background in both pre- and post-launch product support.


Seniority level

* Seniority level

Mid-Senior level


Employment type

* Employment type

Contract


Job function

* Job function

Science
* Industries

Pharmaceutical Manufacturing

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