Senior Director, Regulatory Affairs (Ad Promo)
Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA
Job Requisition ID: 15511
The Senior Director of Advertising & Promotion- Regulatory Affairs drug and device products manages and, if required participates in, the reviews and approvals of advertising and promotional labeling pieces for prescription, over the counter, and cosmetics products for primarily the US but also supports Canada. The Senior Director is responsible for ensuring the pieces are in compliance with regulatory agencies requirements.
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:
- Bachelor's degree in science or health related discipline required (Advanced degree PhD, MD, MS, PharmD preferred). Minimum 10 years of regulatory affairs product advertising and promotion and people management experience required. GI experience - preferred.
- Broad knowledge of the pharmaceutical industry.
- Demonstrated ability to contribute to a continuous learning and process improvement environment.
- Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency.
- Strong interpersonal skills with the ability to influence others in a positive and effective manner.
- Ability to work in a team environment.
- Working knowledge of pharmaceutical and device development and approval process.
- Excellent communication skills; both oral and written.
The range of starting base pay for this role is 215K - 296K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.
Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.
