Associate Director, Regulatory Labeling Strategy or Remote

Position: Associate Director, Regulatory Labeling Strategy or Remote)
Reference: 630928

Posted:

Location:

San Diego, California Company:
Planet Pharma Group Contact:
Applications Email: applications

Position Summary:

The Associate Director, Labeling Strategy is responsible for developing and executing global regulatory labeling strategies throughout the product lifecycle. This role serves as the labeling lead for assigned development and commercial products, ensuring that prescribing information and patient labeling are scientifically accurate, compliant with local regulations, and aligned with the company’s strategic objectives. The Associate Director will partner closely with Regulatory Affairs, Clinical Development, Drug Safety and Pharmacovigilance, Medical Affairs, Commercial, and Legal, and Quality teams to lead the development, negotiation, implementation, and maintenance of product labeling.

The individual will provide strategic guidance on labeling implications for development programs, regulatory submissions, and post-marketing activities. Responsibilities:

Independently leads Labeling multi-disciplinary team (Labeling Working Group – LWG) driving cross-functional collaboration to gain alignment on labeling strategy and labeling content.

Coordinates the process to obtain labeling approval by Executive Labeling Board (ELB), as applicable to the review and approval process.

Authors new/revised TPL, CCDS, and USPI for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations/supporting documents.

Develops and executes a global labeling implementation plans to incorporate new scientific, safety and clinical data, as well as Health Authority responses into CCDS/USPI enabling the most current information and in compliance with labeling requirements Health Care Providers and patients.

Independently authors and manages communications regarding CCDS and labeling updates for assigned products.

Demonstrates strong project management skills to coordinate global labeling functions to ensure timely Health Authority submission and key role in label negotiations with Health Authorities.

Interprets regulations and guidance documents relevant to the development and implementation of labeling documents and assures labeling content and processes conform to regulatory requirements.

Manages process for alignment of local labeling with CCDS for assigned products, including assessment of labeling deviations in US, EU, and ROW.Provides strategic direction and subject-matter guidance to Local Labeling Leads for responses to health authorities’ requests/labeling negotiations.

Appropriately presents issues and seeks endorsement from Executive Labeling Board for proposed risk mitigation strategies, labeling negotiations strategies, and other important/major labeling updates for assigned products.

Conducts precedent, analyzes relevant competitor labeling, assesses labeling guidance and trends, and develops labeling strategies and language for assigned product labels (TPL, CCDS, USPI) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure the most competitive labeling possible.

Represents Global Labeling at Regulatory Satellite, Regulatory Product Strategy, business partner meetings, and other initiatives. Provides regulatory input for the development and revision of carton and container artwork. Collaborate with Technical Operations to implement approved labeling into packaging.

Supports Health Authority Inspections by providing labeling information requests related to assigned products and overall labeling processes.

Manages the Structured Product Label (SPL) process; collaborates with external vendors, ensures SPL is acceptable for submission, and confirms successful…