POSTION SUMMARY
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.
JOB FUNCTIONS/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.
- Liaise with external partners or distributors in international markets, as applicable.
- Conduct research on competitor and other relevant labeling precedents to support high quality, commercially viable labels to support Mirum products.
- Develop project timelines and manage labeling projects from initiation to completion.
- 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).
- Support International Regulatory Affairs colleagues when responding to local health authority queries regarding product labeling.
- Act as primary contact for translation vendors in development of labeling documents in foreign languages.
- Represent Global Regulatory Affairs on the Global Artwork Team; help develop, review, and approve global package artwork in close collaboration with Supply Chain, Quality Assurance, and International Regulatory Affairs colleagues.
- Serve as an expert resource for regulatory labeling advice across departments.
- 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 Mirum products.
- Manage labeling archive and internal trackers.
- Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimization and efficiency.
QUALIFICATIONS
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.
- Capable of critically reviewing complex technical/scientific documents.
- 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.
- Resilient profile with the ability to deliver in an ambiguous environment.
- Ability to engage multiple stakeholders to achieve the business objective, while building excellent working relationships.
- Strong team player that is solution oriented.
- Operationally excellent; ability to work simultaneously on multiple projects with tight timelines.
Work Environment:
- This is a high growth, fast paced small pharmaceutical company. The ability to be productive and successful in such a work environment is critical.
- Some travel required. Responsibilities will require a flexible work schedule that may include periodically working outside of regular business hours, to meet business demands in a company with activities taking place around the globe.
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