Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

Piper Companies is Senior Manager for Regulatory Affairs Labeling Strategy to join the team a global biopharmaceutical company focused in neurology and immunology. In this role, you will lead labeling strategies, ensuring compliance with regulatory requirements while supporting product development and commercialization.

This preferred candidate will be located in the Atlanta, GA or Raleigh, NC regions, however candidates outside of these regions will be considered as well.

Responsibilities of the Labeling Strategy, Senior Manager:

·      Develop and manage labeling strategies for pharmaceutical products.

·      Ensure compliance with FDA and global regulatory standards.

·      Collaborate cross-functionally with regulatory, medical, and commercial teams.

·      Oversee labeling documentation and submission processes.

Qualifications of the Labeling Strategy, Senior Manager:

·      Bachelor’s degree in health sciences, business or related field is required.

·      7+ years of experience in Regulatory Affairs and 5 years of experience in Regulatory labeling strategy.

·      Addition experience with advertising & promotion preferred.

·      Strong knowledge of FDA and global labeling regulations.

·      Excellent communication and project management skills.

Compensation of the Labeling Strategy, Senior Manager:

·      Base salary range of $145,000/year - $165,000/year based on experience

·      Annual bonus and internal equity benefits

·      Comprehensive Benefits including Medical, Dental, Vision, 401k, PTO, Sick Leave if required by law, & Holidays

This job opens for applications on 5/1/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: Regulatory labeling, advertising, and promotion manager, regulatory, labeling, biopharmaceutical, pharma, US labeling, US regulation, drug marketing, drug advertising, global labeling function, GLF, labeling review committee, LRC, FDA, remote, hybrid, Atlanta, GA, Raleigh, NC, ATL, RTP, Boston, MA, North Carolina, Georgia, Massachusetts

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