Regulatory Labeling Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• The Regulatory Labeling Manager – Lifecycle Products oversees the creation, management, and monitoring of labeling content for established pharmaceutical products.

• This position entails drafting and revising labeling documents in response to safety updates, regulatory requirements, and internal evaluations.

• The manager works closely with internal stakeholders to guarantee that governance processes are adhered to and that labeling decisions are thoroughly documented in line with Vertex’s Labeling Procedures.

• Organize and spearhead labeling updates prompted by safety modifications, regulatory obligations, and routine evaluations.

• Create and modify labeling documents such as the Company Core Data Sheets (CCDSs), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), and Rest of World (ROW) labels for lifecycle products.

• Assist in labeling governance activities by collaborating with the team lead and GLL/RLL to prepare materials, participate in governance meetings, and accurately record minutes promptly for upload into the electronic document management system, ensuring that necessary approvals are secured.

• Ensure labeling content meets applicable regulatory standards (e.g., FDA, EMA, ICH) and internal benchmarks.

• Collaborate with cross-functional teams (e.g., Safety, Medical, Legal, Regulatory Strategy) to gather insights and reach consensus on labeling modifications as required.

• Provide support for responses to health authority inquiries pertaining to labeling content.

• Work alongside document specialists and publishing teams to guarantee submission-ready formatting and timely delivery.

• Participate in labeling governance meetings and promptly draft accurate minutes.

• Upload minutes to the electronic document management system.

⛳️ Requirements

• Comprehensive understanding of global labeling regulations and guidelines (FDA, EMA, ICH).

• Demonstrated experience in authoring and maintaining labeling content for approved products.

• Strong command of the English language, including grammar, spelling, and punctuation, along with exceptional proofreading and editing capabilities.

• Excellent organizational skills and meticulous attention to detail.

• Proficient in Microsoft Word and document management systems (e.g., Veeva Vault).

• Familiarity with label tracking systems, such as Intagras and Veeva Labeling.

• Ability to communicate and collaborate effectively with labeling stakeholders.

🏝️ Benefits

• We are dedicated to the development of our people through career advancement opportunities, supportive and engaged management, technical and therapeutic area training, peer recognition, and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.