Overview
Remote
On Site
USD 145,000.00 - 165,000.00 per year
Full Time
Skills
Immunology
Product Development
Pharmaceutics
Regulatory Compliance
Collaboration
Management
Documentation
Science
Regulatory Affairs
Advertising
Promotions
Communication
Project Management
Law
Job Details
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.
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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.