Manager, Regulatory Affairs Labeling

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 9 products in the market that are making a real impact on patient outcomes.

The Manager of Regulatory Affairs Labeling is responsible for the development, review, and approval of commercial product labeling (Prescribing Information, Patient Information, Medication Guides, and Instructions for Use) and printed component artwork (cartons, container labels, blister foils and pouches) across the assigned Supernus commercial portfolio. This role partners with Clinical Development, Medical Affairs, Commercial, Quality, Technical Operations, Supply Chain, and external graphic and packaging vendors to ensure all labeling and artwork content is accurate and compliant with FDA regulations and ICH guidelines.

The Manager serves as the subject matter expert on labeling and artwork content governance for assigned products and mentors cross-functional partners on labeling requirements, associated change controls, and content governance.

• Develops, authors, and revises Prescribing Information, Patient Information, Medication Guides, Instructions for Use (IFUs) current Food and Drug Administration (FDA) regulations (21 CFR Part 201) and guidance documents.
• Leads cross-functional labeling and artwork initiatives and drives alignment between Regulatory Affairs, Clinical Development, Medical Affairs, Commercial, Quality, Technical Operations, and Supply Chain.
• Supports response to FDA labeling inquiries, Information Requests, and post-marketing commitment deliverables; partners with Regulatory Operations on submission publishing.
• Drafts and revises Company Core Data Sheets (CCDS) and participates in Target Product Profile/Labeling (TPP/TPL) to support product portfolio and lifecycle of products.
• Coordinates the development of Structured Product Labeling (SPL) files for FDA submission, including proofing, validation, and electronic submission via the FDA Electronic Submissions Gateway (ESG).
• Maintains labeling change history, source-text documentation, annotations, and supporting documents for labeling revisions.
• Reviews and approves printed-component artwork for regulatory compliance, readability, accuracy, and alignment with approved labeling content.
• Coordinates with external graphic vendors and packagers and Supply Chain to ensure timely and accurate artwork development for new launches, product line extensions, and post-approval changes.
• Authors, reviews, and improves departmental SOPs, work instructions, and best-practice documentation for labeling and artwork management.
• Manages, mentors and trains junior regulatory staff and cross-functional partners on labeling requirements, change control, artwork review standards, and content-governance SOPs.
• Performs regulatory intelligence by monitoring regulation changes and issuance of new guidance documents, as well as new product labeling from competitors and products in therapeutic areas that may impact the labeling of the Supernus portfolio.
• Supports promotional activities by assisting in incorporation of new labeling content into Important Safety Information documents and implementation of newly approved labeling content in print and digital formats.
• Educates and trains cross-functional departments on new labeling regulations and guidance documents that impact the portfolio.
• Department representative on selected project teams for commercial product launches and completion of post-marketing commitments.
• Other duties as assigned.

• May perform supervisory responsibilities as assigned, consistent with business needs and the scope of the role.

• Pharm.
  
  D. with 1+ years of experience, master’s with 4+ years, or a bachelor’s with 5+ years of relevant experience in Pharmaceutical Regulatory Affairs.
• At least two years of experience focused specifically on labeling creation, artwork preparation or related content-governance activities.
• Working knowledge of FDA regulations governing prescription drug labeling, including 21 CFR Part 201 and ICH guidelines.
• Experience with therapeutic areas for which Supernus promotes products.
• Experience with the Microsoft Office Suite.
• Experience with regulatory document-management or…