Manager, Regulatory Affairs Advertising & Promotion

Posted 13 May 2020
Salary Negotiable
Location
Job type Permanent
ReferenceBBBH103256_1589410071
Contact NameBria Gaber

Job description

Manager, Regulatory Affairs Advertising & Promotion

Pennsylvania - United States

Seeking an experienced global leader within Regulatory Affairs with a strong background handling Advertising and Promotional material review for biopharmaceutical organizations to work in our Philadelphia office. This candidate will join the leadership team and will provide oversight and direction, with a level of expertise, to the global promotional programs to ensure compliance supports the goals and objectives of the company and meet all regulations. Seeking a strong collaborator with proven leadership skills with a successful track record of developing and executing regulatory new marketing concepts and promotional strategies, while working collaboratively cross-functionally with the team.

Responsibilities:

  • Leading the planning, execution and assessment of product life cycle management activities and strategies
  • Lead the promotional material review committee (PMRC) process for assigned products and create all materials to meet FDA regulations and company objectives.
  • Ability to work cross-functionally and collaboratively with compliance, medical, legal, commercial entities and applies expertise and influence to ensure development of promotional programs are all compliance with regulations and company goals.
  • Provide guidance and expertise on new marketing concepts and promotional strategies for assigned products.
  • Lead and prep submission of INDs/CTAs/MAAs/NDAs/BLAs
  • Ensure all promotional content, quality, precision as well as format of submissions comply with internal procedures and FDA guidance's.
  • Assist with the leading and liaising of Health Authorities' interactions

Qualifications:

  • BA/BS degree or equivalent experience is required (Advanced degree preferred)
  • At least 5 years of pharmaceutical industry experience (no Generics)
  • At least 5 years of direct experience in Regulatory Ad/Promo Material review
  • New product launch experience
  • Strong working knowledge and experience with FDA regulations

If interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com or (646) 430-1191 for more information.