Executive Director, Regulatory Affairs (AdPromo)

Role Summary

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it where your skills and values drive our collective progress and impact.

Responsibilities

• Manages the Regulatory Promotional reviewers for products who represent Regulatory Affairs on the promotional review committee for preapproval and marketed products. This position may require reviewing promotional materials if the company requires it and escalations. This person is responsible for compliance with regulatory requirements while meeting Company's strategic promotional objectives.
• Provide guidance on proposed claims for products in development and development of ISI and brief summaries.
• Regularly monitor the regulatory compliance trends in industry, interpret new regulations, guidance documents and enforcement letters.
• Update the Regulatory Ad Promo staff, review committees and appropriate other company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP), Canada Pharmaceutical Advertising Advisory Board (PAAB) and other regulatory considerations that may impact business. Develop or revise procedures needed.
• Review packages for regulatory advice, resolution of FDA and Canadian action letters and leads the company in discussions with the FDA OPDP and Canada PAAB.
• Coordinate companywide ongoing regulatory training on regulatory issues pertaining to promotion of Company products.
• Represents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo.
• Interacts with Legal, Compliance and Medical Affairs regularly. Also works with Quality related to internal audits and CAPAs, as needed.

Qualifications

• Required: Bachelor's degree in science or health related discipline. Advanced degree (PhD, MD, MS, PharmD) preferred.
• Required: Minimum 15 years of regulatory affairs product advertising and promotion and people management experience.
• Preferred: GI experience.
• Required: Broad knowledge of the pharmaceutical industry. Demonstrated ability to contribute to a continuous learning and process improvement environment.
• Required: Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency.
• Required: Strong interpersonal skills with the ability to influence others in a positive and effective manner.
• Required: Ability to work in a team environment.
• Required: Working knowledge of pharmaceutical and device development and approval process.
• Required: Excellent communication skills; both oral and written.