Regulatory Affairs

Description:

Nestlé Health Science is seeking a Senior Manager, Regulatory Affairs – Labeling, Advertising & Promotions to lead regulatory strategy, compliance, and submissions related to product labeling, advertising, and promotional materials across global markets. This role reports to the Head of Global Regulatory Affairs Pharma and involves close collaboration with cross-functional teams to ensure regulatory alignment throughout the product lifecycle.

Key Responsibilities:

• Lead regulatory strategy and oversight for product labeling, advertising, and promotion across pre- and post-launch activities.

• Oversee development and maintenance of Target Product Profiles (TPP), Company Core Data Sheets (CCDS), and labeling documentation.

• Manage and optimize Veeva systems for labeling and promotional material review and approval.

• Coordinate cross-functional meetings on labeling changes, artwork updates, and regulatory submissions.

• Serve as primary contact and signatory for FDA APLB (Advertising Promotion Labeling Branch) submissions and advisory comments for BLAs and commercial products.

• Develop and manage processes for acquired products’ regulatory integration and ensure compliance with SOPs.

• Supervise and mentor regulatory staff while providing strategic regulatory guidance across internal teams.

Qualifications:

• Bachelor’s degree in a scientific discipline; Regulatory Affairs Certification (RAC) preferred.

• 10+ years of experience in regulatory affairs within a pharmaceutical or biotech environment.

• Proven expertise in labeling, advertising, promotion, and change control processes.

• Experience with regulatory submissions, electronic document preparation, and promotional review systems.

• Strong knowledge of FDA regulations, global regulatory standards, and commercialization processes.

• Excellent strategic thinking, communication, and leadership skills.