Assoc. Director, Regulatory Affairs-Ad/Promo - REMOTE

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Consultant / Specialist, Operations
  3. United States
Atlanta, USA
Posting date: 19 Jan 2024
RA.PH.57832

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Assocaite Director, Regulatory Affairs - Permanent - Remote

Proclinical is seeking an Associate Director, Regulatory Affairs-Ad/Promo to join a global pharmaceutical company. This is a permanent role with the opportunity to work remotely.

Primary Responsibilities

In this role, you will provide oversight of the US Regulatory Advertising, Promotion and Labeling team as the US Regulatory expert for regulation of ad/promo and industry standards for labeling. You will direct the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling. You will stay abreast of requirements for US regulation of drug marketing and advertising and competitive landscape, communicating FDA requirements and trends to company departments involved in the preparation or review of external communication materials. The position can be based at their Georgia site (preferred) or remote-based within the United States.

Skills & Requirements:

  • Bachelor's Degree with 7+ years of relevant experience in the pharmaceutical industry with 5+ years in Regulatory Affairs and specific experience in US Advertising and Promotion/Labeling experience.
  • Must be eligible to work in the US.

The Associate Director, Regulatory Affairs will:

  • US Regulatory expert in US regulation of advertising and promotion and industry standards for labeling and communicate requirements to others as needed.
  • Oversight of the development and maintenance of procedures for the regulatory aspects of labeling preparation, review, approval and submission.
  • Direct the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling.
  • Interface with the Head of Global Labeling Function to ensure consistency of labeling processes and local compliance with CCDS.
  • Serve as US Regulatory labeling expert in internal and external audits.

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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