Regulatory Affairs Manager

Review and approve promotional materials to ensure compliance with applicable regulations, approved labeling, corporate policies, divisional procedures, and ethical business practices. Collaborate with cross-functional stakeholders to support product claims, assess and mitigate regulatory risk, and enable compliant communications throughout the product lifecycle.

What You'll Work On

• Provide regulatory input to product lifecycle planning.
• Combines scientific, regulatory, and business expertise to assess product claims, evaluate regulatory risk, and provide guidance that supports compliant product communications and business objectives.
• Reviews and aligns product communications with applicable regulations, approved labeling, corporate policies, and divisional procedures to maintain compliance throughout all stages of the product lifecycle.
• Support the development, maintenance, and implementation of multi-country regulatory strategies, as applicable.
• Utilize regulatory expertise to develop strategies and recommendations on complex regulatory issues.
• Identify and assess emerging regulatory issues and changes that may impact business activities.
• Provide regulatory guidance and support to regional and country Regulatory affiliates on advertising, promotional, digital, and external communications activities, as needed.
• Interpret and apply regulatory requirements, company policies, and divisional procedures to support compliant business activities.
• Communicate regulatory risks and recommend appropriate risk mitigation strategies to stakeholders.
• Support alignment and consistency of regulatory approaches for promotional and external communications across global, regional, and local markets, as appropriate.
• Partners cross-functionally to support business needs while acting as a trusted regulatory resource, providing expertise, guidance, and knowledge sharing to drive team and organizational success.
• Contribute to the continuous improvement of regulatory review processes, procedures, and training related to advertising and promotion activities.

Required Qualifications

• Bachelor's Degree (or equivalent).
• 4-5 years' experience in a regulated industry (e.g., medical products, nutritionals).

Preferred Qualifications

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
• M.S. in a technical area or M.B.A. is preferred.
• Ph.D. in a technical area or law is helpful.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.
• 2(+) years in Ad/Promo (Advertising / Promotions) regulatory experience with any of the following medical products: IVD's, Clinical Chemistry, and/or Pharmacology.