Manager, Regulatory Affairs - Advertising and Promotion

Overview

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

The Manager of Regulatory Affairs, Advertising and Promotion, is responsible for representing the Regulatory Affairs department at Promotional and Medical Review Committee meetings ensuring alignment with promotional strategies and regulatory expectations. This role functions as the subject matter expert on Food and Drug Administration (FDA) laws and regulations regarding the marketing of Supernus’s pharmaceutical and medical products. Incumbents in this role will be responsible for reviewing marketing materials, collaborating with cross-functional teams, and providing regulatory guidance to minimize risk, and ensure accurate product messaging.

• Conducts regulatory review of advertising and promotional materials for assigned products and disease states.
• Serves as the Regulatory Affairs department representative on the Promotional and Medical Review Committees.
• Provides oversight of submission of promotional materials to the FDA’s Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB).
• Serves as the subject matter expert for Regulatory Affairs to the marketing and sales departments.
• Assists with postmarketing supplements to marketed product applications.
• Implement labeling changes by preparing Important Safety Information and Brief Summary documents.
• Performs regulatory intelligence by monitoring OPDP and APLB enforcement, regulation changes and issuance of new guidance documents.
• Educates and trains cross-functional departments on prescription drug advertising regulations and labeling regulations.
• Department representative on selected project teams for commercial product launches and completion of post-marketing commitments.
• Interfaces with licensees regarding ex-US sales and promotion of commercial products.
• Other duties as assigned.

• N/A.

• Pharm.
  
  D. and no experience, master’s with four years, or a bachelor’s with five years of relevant experience in Pharmaceutical Regulatory Affairs.
• At least one year of experience with largely independent review of advertising and promotional materials is highly preferred.
• Medical, pharmacy, clinical science, or medical-legal background strongly preferred.
• Experience with direct interface with FDA OPDP or APLB desirable.
• Experience with therapeutic areas for which Supernus promotes products.
• Experience with the Microsoft Office Suite.
• Experience with Veeva Promo Mats.
• Requires excellent interpersonal and good corporate presentation skills.
• Excellent written and verbal communication skills.

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability to have an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• The worker is not substantially exposed to adverse environmental conditions.

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary…