Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

Piper Companies; Atlanta (GA); Remote; USD 145,000 - 165,000; Full time

Job summary

An established industry player is looking for a Senior Manager for Regulatory Affairs - Labeling Strategy to lead innovative labeling strategies in the biopharmaceutical sector. This remote role involves ensuring compliance with regulatory standards and collaborating with cross-functional teams to support product development. The ideal candidate will possess extensive experience in regulatory affairs, particularly in labeling, and have a strong understanding of FDA regulations. Join a dynamic team dedicated to advancing neurology and immunology treatments while enjoying comprehensive benefits and a competitive salary package.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401k

PTO

Sick Leave

Holidays

Annual Bonus

Qualifications

• 7+ years of experience in Regulatory Affairs with a focus on labeling.
• Strong knowledge of FDA and global labeling regulations.

Responsibilities

• Develop and manage labeling strategies for pharmaceutical products.
• Ensure compliance with FDA and global regulatory standards.

Skills

Regulatory Affairs

Labeling Strategy

FDA Compliance

Project Management

Communication Skills

Education

Bachelor’s degree in health sciences

Bachelor’s degree in business

Job description

Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

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Position Overview

Piper Companies is seeking a Senior Manager for Regulatory Affairs Labeling Strategy to join a global biopharmaceutical company focused on neurology and immunology. The role involves leading labeling strategies, ensuring compliance with regulatory requirements, and supporting product development and commercialization.

This position is preferred in the Atlanta, GA or Raleigh, NC regions; however, candidates outside these areas will also be considered.

Responsibilities

• Develop and manage labeling strategies for pharmaceutical products.
• Ensure compliance with FDA and global regulatory standards.
• Collaborate with regulatory, medical, and commercial teams.
• Oversee labeling documentation and submission processes.

Qualifications

• Bachelor’s degree in health sciences, business, or a related field.
• 7+ years of experience in Regulatory Affairs and 5+ years in Regulatory labeling strategy.
• Experience with advertising & promotion is preferred.
• Strong knowledge of FDA and global labeling regulations.
• Excellent communication and project management skills.

Compensation

• Base salary range of $145,000 - $165,000 per year, based on experience.
• Annual bonus and internal equity benefits.
• Comprehensive benefits including Medical, Dental, Vision, 401k, PTO, Sick Leave (as required by law), and Holidays.

This job opening is posted on 5/1/2025, and applications will be accepted for at least 30 days.

Additional Details

Keywords include regulatory labeling, advertising, promotion management, biopharmaceuticals, pharma, US labeling and regulation, drug marketing, global labeling, FDA, remote work, and locations such as Atlanta, GA, and Raleigh, NC.

Other Information

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Legal
• Industries: Business Consulting and Services