Description
Syneos Health is seeking a Regulatory Labeling Manager to develop, maintain, and oversee labeling content for mature pharmaceutical products.
The Regulatory Labeling Manager – Lifecycle Products is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products (products that have no additional development activities ongoing).
Key Responsibilities:
- Plan and lead labeling updates driven by safety changes, regulatory commitments, and periodic reviews.
- Author and revise labeling documents including 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.
- Support labeling governance activities by collaborating with the team lead and GLL/RLL to prepare materials, attend the governance meeting, and record accurate minutes.
- Ensure labeling content complies with applicable regulatory requirements (e.g., FDA, EMA, ICH) and internal standards.
- Collaborate with cross-functional teams (e.g., Safety, Medical, Legal, Regulatory Strategy) to gather input and align on labeling changes.
Required Knowledge/Skills:
- Strong understanding of global labeling regulations and guidance (FDA, EMA, ICH).
- Proven experience authoring and maintaining labeling content for approved products.
- Strong command of English language including grammar, spelling, and punctuation.
- Exceptional proofreading and editing skills.
- Strong organizational skills and attention to detail.
- Proficiency in Microsoft Word and document management systems (e.g., Veeva Vault).
- Experience using Label tracking systems, e.g., Intagras, Veeva Labeling.
Typically 2+ years of experience in the biotechnology industry, preferably in Regulatory Affairs, Regulatory Labeling or a related discipline. Minimum Bachelor's degree, in a Science or Business-related field.