Director Global Regulatory - Labeling

Director, Global Regulatory Affairs Labeling

Location: Foster City

The Director, Regulatory Affairs Global Labeling will play a key role in providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation for marketed products. The Director will partner with all Regulatory Affairs functions, Medical Affairs, Legal, Clinical Development, Commercial and International distributors and will lead the Label Working Group. This role will report to the SVP, Global Regulatory Affairs.

Responsibilities

• Create and maintenance of labeling content for assigned programs of marketed product(s) and development products in US and international regions including: CCDS, prescribing information, medication guides, patient information/leaflet/IFU, package label artwork.
• Leads the Label Working Group (LWG) and internal review and approval process of labeling documents.
• Conduct research on competitor and other relevant labeling precedents to support high quality, commercially viable labels to support products.
• Represent Regulatory Affairs at labeling meetings and provide strategic regulatory guidance, as appropriate.
• Ensure labeling is compliant with local country regulations and guidance. This can be accomplished by managing and utilizing local resources (e.g., in-country or in-region labeling consulting services).
• Author or collaborate with regulatory colleagues on regulatory submissions of labeling documents (package inserts, container labeling artwork).
• Act as primary contact for translation vendors in development of labeling documents in foreign languages.
• Maintain a continued awareness and understanding of FDA, EMA, and international health authority regulations, guidance documents with regards to product labeling for pharmaceutical products; assess impact of new regulations on products.
• Manage labeling archive and internal trackers.
  
  

Education/Experience:

• Bachelor’s or advanced degree in a scientific discipline with a minimum of 12 years in Regulatory Affairs and a minimum of 8-10 years of regulatory labeling experience in the biopharmaceutical industry. Experience with writing, developing, maintaining product labeling in the US and EU is required and around the globe is desirable including Asia-
• Pacific, LATAM, and Middle East.
• Experience representing Regulatory Affairs Labeling on cross functional teams.
  
  

Knowledge, Skills and Abilities:

• Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
• Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others. Must be self-directed.
• Experience with global rules and regulations regarding labeling of medical products is highly desirable, as is experience with US FDA and international Health Authorities.
• Experience with using Veeva Vault RIM and QualityDocs is desirable.
• Salary Range of $230-260k base plus bonus and equity
  
  

How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to tom@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume.