Associate Director, Regulatory Affairs, Advertising & Promotion

05 Sep, 2020

Jobs

Associate Director, Regulatory Affairs, Advertising & Promotion

Alkermes
Waltham, MA

Position Summary: 

Reports to the Executive Director, Regulatory Affairs, Advertising & Promotional Labeling. Works with other personnel in Marketing, Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments in support of initiatives and Copy Clearance Committee (CCC) process and review of external communications materials. Develops and maintains positive working relationships within and across departments in relation to promotional issues. Contributes to negotiations with FDA as necessary.

Essential Functions: 

FDA Compliance:

  • Assure full regulatory compliance of all advertising and promotion materials with approved labeling.
  • 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 guidances, 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 Alkermes.
  • 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

CCC Process:

  • 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.

Submissions:

  • 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.
  • Some travel required.

 

Preferred Requirements:

  • A minimum of eight (8) years pharmaceutical industry experience, including direct FDA Regulatory Affairs interaction (submissions and negotiations). Demonstrated success with commercial launch of new drugs.
  • 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.

 

 

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.

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Job posted: 2020-09-05