Senior Manager, Regulatory Labeling

Role Summary

The Senior Manager, Regulatory Labeling manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU SmPC and Rest of World (RoW) labeling. Provides labeling expertise to the Labeling Working Group and other relevant stakeholders, typically carrying out responsibilities with minimal guidance. Leads development of labeling strategies and is responsible for the management of marketed or pipeline products, across the product lifecycle.

Responsibilities

• Manages the Regulatory labeling process throughout the product lifecycle.
• Leads the Labeling Working Group and manages development, review, approval, and maintenance of labeling for CCDS, USPI, EU SmPC, and RoW labeling. Manages complex programs with minimal support from the Labeling Director.
• Leads development of labeling strategies through interpretation of labeling regulations, guidelines and competitor analyses, and application to product situation.
• Leads the development of target labeling documents to support the design and analysis plan for clinical trials, with guidance from the Labeling Director.
• Leads or contributes to discussions on labeling topics at relevant management interactions.
• Effectively communicates labeling rationales to various levels of management to enable decision making.
• Provides labeling expertise on complex issues to stakeholders. Anticipates Health Authority (HA) perspectives and broader implications of strategies, proposing alternatives and providing advice to mitigate risk. Communicates consequences to product portfolio.
• Prepares submission-ready labeling documents. Maintains labeling documents in the electronic document management system and relevant labeling trackers as appropriate.
• Contributes to the development of the Regulatory Labeling Group through active knowledge sharing and mentoring of junior staff members to build labeling expertise.
• Monitors worldwide regulation changes pertaining to Labeling regulations and maintains the labeling SOP and work instructions. May be responsible for leading or contributing to various continuous improvement projects.

Qualifications

• Ability to think strategically, assess risks and propose strategies to manage risk.
• Ability to lead Labeling Working Groups to address labeling issues, develop plans of action, and oversee completion of complex labeling projects.
• Expert knowledge of FDA, EMA, and international labeling regulations, ICH guidelines, and CIOMS core labeling guidelines.
• Ability to assimilate clinical and scientific information and present it in a concise manner.
• Ability to work independently and use judgment to make decisions and escalate problems appropriately.
• Proactively share information with peers and generate discussion to resolve complex issues.
• Ability to handle multiple projects and prioritize work independently.
• Ability to operate in ambiguous situations and provide functional guidance to others.
• Attention to detail and strong word processing skill.

Education

• At minimum, a Bachelor‚Äôs degree (BS) in Life Sciences. An advanced degree (Masters, Pharm D, Ph.D, MD or DO) preferred. Regulatory experience can offset education requirements.

Experience

• 3-4 years of related Biotech or Pharma industry experience, with 2 or more years working with labeling preferred.
• In-depth knowledge of the labeling process, industry practice, packaging manufacturing process, and the drug development process. Familiar with policies and operating procedures in medical safety regulatory and/or corporate and worldwide Regulatory Agencies.