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OPEN JOB: Pharma - Associate Director, US Advertising and Promotion, Global Regulatory Affairs - Hybrid

Cambridge, MA
OPEN JOB: Pharma - Associate Director, US Advertising and Promotion, Global Regulatory Affairs - Hybrid

LOCATIONS: this is a hybrid role based in either Bridgwater, NJ or Cambridge, MA. Hybrid work arrangement. Candidate must be in office 2-3x/week at either Bridgewater NJ or Cambridge MA location.

TARGET COMP: $150,000 to $175,000

Candidate must be either a US Citizen or Green Card Holder

The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.

As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics. 

Essential Functions    
  • Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of US advertising, promotion, disease-state, market access, and press materials. Submits materials on form FDA 2253 when applicable.
  • Provides US RA AdPromo strategic guidance and subject matter expertise for responsible investigational and marketed products, to meet both short- and long-term business objectives while mitigating risk. Consults with senior management and provides input to the global organization as needed. 
  • Contributes US RA AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications.
  • Primary Liaison with OPDP/APLB and effectively manages relationships with FDA contacts. Establishes and maintains strong collaborative relationships with Regulatory and other R&D colleagues, as well as other stakeholders (e.g., Legal, Medical, Marketing, Communications and Compliance).
  • Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion.
  • Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.
  • Participates in the development, monitoring and updating of standards and processes related to drug, device, and biologics US AdPromo regulations and guidances.

Other Position Responsibilities:
  • Work with other RC team members to provide input into improvement of systems and/or processes.
  • Provide teams with insight into changes in the regulatory environment, including updates on FDA enforcement letters, meetings, guidance documents, and policies, etc.
  • Review current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed.

Minimum Requirements:
  • Bachelor’s degree from an accredited four-year college or university (Area of specialization: Life Sciences)
  • At least five (5) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.
  • Significant understanding of the U.S. pharmaceutical marketplace, especially the rules and regulations related to the promotion of prescription drugs in the United States
If you are interested in pursuing this opportunity, please respond back and include the following:
  • MS WORD Resume
  • required compensation.
  • Contact information.
  • Availability
Upon receipt, one of our managers will contact you to discuss the position in full detail.

Steve Fleischner
Recruiting Manager

EMAIL: steve@intermediagroup.com
LINKEDIN: https://www.linkedin.com/in/stevefleischner/

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