Senior Manager, Regulatory Operations Ad/Promo

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

Seeking an experienced Global Regulatory Operations professional with a strong background within advertising and promotions. This Senior Manager will join the leadership team and manage a global team with the reviewal and approval 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:

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