Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

Jobs via Dice; Atlanta (GA); Remote; USD 145,000 - 165,000; Full time

Job summary

An established industry player in biopharmaceuticals is seeking a Senior Manager for Regulatory Affairs - Labeling Strategy. This pivotal role involves leading the development of labeling strategies and ensuring compliance with regulatory standards, particularly in the fields of neurology and immunology. You will collaborate closely with regulatory, medical, and commercial teams to oversee documentation and submission processes. With a competitive salary and comprehensive benefits, this opportunity offers a chance to significantly impact product development and commercialization in a dynamic environment. If you have a passion for regulatory affairs and a commitment to excellence, this role is for you.

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 strategy.
• Knowledge of FDA and global labeling regulations is essential.

Responsibilities

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

Skills

Regulatory Affairs

Labeling Strategy

Communication Skills

Project Management

Education

Bachelor's degree in health sciences

Bachelor's degree in business

Job description

Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

Join to apply for the Regulatory Affairs - Labeling Strategy, Senior Manager (Remote) role at Jobs via Dice.

Overview

Our client, Zachary Piper Solutions, LLC, 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 standards, and supporting product development and commercialization.

Location

Preferred candidates will be located in Atlanta, GA or Raleigh, NC, but candidates outside these regions will also be considered.

Responsibilities

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

Qualifications

1. Bachelor's degree in health sciences, business, or related field.
2. 7+ years of experience in Regulatory Affairs and 5+ years in Regulatory labeling strategy.
3. Knowledge of FDA and global labeling regulations.
4. Excellent communication and project management skills.
5. Experience with Advertising & Promotion is preferred.

Compensation and Benefits

Salary range: $145,000 - $165,000 annually, based on experience. Includes annual bonus, medical, dental, vision, 401k, PTO, sick leave, and holidays.

Application Details

Applications open on 5/1/2025 and will be accepted for at least 30 days.