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Job Details

Associate Director, Regulatory Affairs – Advertising and Promotion

Company: RBW Consulting
Location: Boston, MA
Reference: raa-adraap-bma
Closing Date: 20 Mar 18
Type: Full Time
Salary (£): 100,000+
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Requirements:

Associate Director, Regulatory Affairs – Advertising and Promotion

Boston, MA

Reports to the Senior Director, Regulatory Affairs, Advertising & Promotional Labelling. Develops and maintains positive working relationships within and across departments in relation to promotional issues. Contributes to negotiations with FDA as necessary.

Responsibilities:

  • Assure full regulatory compliance of all advertising and promotion materials with approved labelling.
  • Handle other duties and/or special projects as assigned by the Senior Director Regulatory Affairs.
  • Maintain up-to-date knowledge of FDA laws, regulations and guidance, as well as the compliance environment as it relates to advertising and promotion of pharmaceuticals and devices. Advise appropriate departments within the company of these requirements. Assist the Senior Director in establishing procedures to assure compliance with these requirements.
  • Provide training in FDA regulations for advertising and promotion to employees and agents of the company.
  • Review of draft and final advertising and promotional materials for marketed products, as assigned.
  • Coordinate and supervise the development of regulatory strategies for investigational, new or modified pharmaceutical products.
  • Approve specified regulatory submissions
  • Assists the Senior Director in development and implementation of strategy to maintain efficient and compliant CCC process.
  • Builds a strong relationship with internal customers; including Marketing, Marketing Operations, Legal and Medical.
  • Builds a strong relationship with the FDA
  • Other duties as deemed appropriate by Senior Director.
  • Provides regulatory review of draft promotional materials (pre-CCC).
  • Acts as lead Regulatory CCC reviewer.
  • Supports development of launch materials/new claims by collaborating with Marketing, Medical and Legal. Prepares FDA submissions, including draft introductory promotional materials for advisory comment.
  • Assure company compliance with FDA and FTC requirements and strategy.
  • Ensure timely and accurate submission of promotional materials to FDA under form FDA-2253.
  • Oversee preparation and submission of draft introductory materials to FDA for advisory comment.

Basic Requirements:

  • Bachelor’s degree required; advanced degree preferred.
  • A minimum of (6) years Regulatory Promotional Review experience required.
  • Detail & deadline oriented; well organized.
  • Excellent verbal & written communication skills
  • Good interpersonal skills; ability to interact with staff on all levels.
  • Works independently with minimal supervision.
  • Some travel required.

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Associate Director, Regulatory Affairs – Advertising and Promotion

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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