Senior Manager, Regulatory Operations Ad/Promo

Senior Manager, Regulatory Affairs Ad/Promo
Pennsylvania - United States

Seeking an experienced Regulatory Affairs professional with a strong background within advertising and promotions. This candidate will be leading the group in the promotional materials review process and looking for someone highly skilled within this area. This Senior Manager will join the leadership team and manage a global team in the reviewing and approving of submissions. There's a new product launch and this new hire will be expected to lead, develop, and review regulatory strategies for all promotional materials for marketed and pipeline products. You'll have the opportunity to provide regulatory input to various functional units on promotional labeling for marketed and to-be marketed drugs and serve as the lead regulatory affairs representative.

Responsibilities:

• Lead the promotional team with 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 the 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 guidances.
• Assist with the leading and liaising of Health Authorities' interactions

Qualifications:

• BA/BS degree or equivalent experience is required (Advanced degree preferred), with at least 5 years of pharmaceutical industry experience, including 5 years of direct experience in advertising and promotional material review is required.
• Direct experience managing/leading a team
• New product launch experience
• Strong working knowledge and experience with FDA regulations

If interested you meet the basic Qualifications and interested in learning more, please contact Bria Gaber at (646) 430-1191 or bria.gaber@investigo-us.com.