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Associate Director, US Advertising & Promotion (Global Regulatory Affairs)

Full time @Source For Hire LLC in Pharmaceutical/Biotech
  • United States, United States View on Map
  • Post Date : June 20, 2024
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Job Detail

  • Experience  7 Years
  • Industry  Biotechnology
  • Qualifications  Bachelor's Degree

Job Description

Title: Associate Director, US Advertising & Promotion (Global Regulatory Affairs)

Location: Hybrid – Bridgewater NJ or Cambridge MA

Client’s Industry: Pharmaceutical/Biotechnology

Term: Full Time

Candidate serves as the regulatory lead on relative Review Committee (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio. You will 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.

Responsibilities:

  • 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
  • Significant understanding of the US pharmaceutical marketplace, especially the rules and regulations related to the promotion of prescription drugs in the United States
  • Candidate will require strong verbal and written communication skills, strong interpersonal skills, good listening skills, strong negotiation skills, prior experience demonstrating customer focus and ability to facilitate appropriate team decisions
  • This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned, as well as for all verbal and written communications with OPDP/APLB reviewers

Education/Qualifications:

  • BA/BS degree from an accredited 4-year college or University (Area of specialization: Life Sciences)
  • Minimum of 7 years of experience involving the direct implementation of promotional labelling 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

No 3rd Party

Interested applicants, please click on the link here: Job Listings | Source For Hire | Recruiting & Staffing Support  to review the full job description and apply now for immediate consideration.