Regulatory Affairs Specialist (Advertising and Promotion Review)

The Advertising and Promotion Regulatory Affairs role will provide strategic regulatory expertise, and guidance to internal and external stakeholders related to the review of scientific information, advertising, promotional and other related materials for assigned products to ensure compliance with applicable regulations and guidance documents. The individual will represent regulatory on the PRC (Promotional Review Committee) team for assigned products and must possess a thorough knowledge of regulations for advisement and promotional compliance, governing drugs, device and combination products. The individual should have experience reviewing promotional materials that are subject to both EU MDR and FDA regulations.

Duties

Material Review

Review and approve proposed advertising and promotional materials for multiple product lines.

Regulatory Awareness

Maintain current awareness of evolving EU MDR and FDA regulations and interpretations, enforcement letters and policy issues affecting the pharmaceutical and medical device industries.

Coordination of promotional review

Ensure adherence and compliance to the review and release process.

Guidance on claims, ISI and Brief Summaries

Provide guidance and risk assessments on proposed claims for products in development and development of ISI (Important Safety Information) and Brief Summaries.

Creation of launch materials

Work closely with R&D project teams and marketing to advise on labeling and launch materials for new products and indications.

Management of regulatory support related to advertising and promotion

Oversee timely and accurate submissions related to promotional materials as needed. This includes supporting audits that may request samples of approved promotional material and documentation of review processes as well as any required submissions to health authorities related to advertising and promotion.

Monitoring the regulatory compliance trends and competitive materials in the aesthetic industry

Regularly monitor the regulatory compliance trends in the aesthetic industry, interpret new regulations, guidance documents and enforcement actions.

Regularly monitor and advise on publicly available competitor materials to provide awareness and advice on current market trends and messaging.

Technical & Functional Skills

Strong knowledge of EU MDR and FDA regulations and guidance pertaining to drug and device advertising, promotion, and labeling

Proficiency in Microsoft Outlook, Excel, PowerPoint and Word and comfort with large variety of online meeting tools and AV equipment

Excellent written, oral and interpersonal communication skills

Demonstrated history of teamwork and cross functional collaboration

Demonstrated history of creative problem solving and risk analysis related to promotional materials in the drug and medical device industry

Minimum Qualifications

Bachelor’s Degree – a 4-year undergraduate degree in a scientific background (medicine, pharmaceutical sciences, human biology, or chemistry.)

5 years’ experience in regulatory drug and medical device promotion review

Preferred Qualifications

Master’s degree or higher in the above field is highly desirable