Associate Director Regulatory Global LabelingLocation San Rafael, California Apply
Reg Global Labeling Job Description
Associate Director Level
The Associate Director of Regulatory Global Labeling (REG-GL) is a strategic and operational role to manage labeling projects from cradle to grave. The incumbent will beresponsible for the development and maintenance of regulatory compliant, competitive, and up-to-date core labeling and local labeling documents for assigned key development projects and marketed products throughout the product’s lifecycle. TheAssociate Director is responsible for the management of labeling for multiple products in development and commercialized. The Associate Director of REG-GL provides strategic and operational regulatory labeling input to labeling content, submission, production, and implementation worldwide. The Associate Directorworks in close collaboration with subject matter experts on the Product Labeling Teams (PLT), Global Regulatory sub-teams, and Senior Management Review Teams to ensure the execution of global regulatory labeling plans are aligned with the global regulatory strategy and with BioMarin’s labeling processes and standards.
This position will be responsible for:
- Providing regulatory strategic guidance and oversight of global labeling activities for BioMarin commercial products and development products.
- Providing regulatory strategic guidance to development teams on the clinical design requirements to support labeling claims.
- Lead the Product Labeling Teams to develop labeling content for global and local labeling worldwide. Including the development and management of the Company Core Data Sheets.
- Ensuring commercial product labeling is compliant with the worldwide regulations and is of the highest quality.
Support the BioMarin product portfolio, as assigned, and the Regulatory Global Labeling Group on key labeling initiatives and processes.
Regulatory Labeling Strategy:
• Organize and lead cross functional expert labeling Product Labeling Teams (PLT) (including experts from Regulatory, Clinical, Safety, Technical Operations, Supply Chain, Pharm Tox, REG CMC, etc.) to discuss labeling strategy, reach consensus on global labeling matters, assess impact of regional/local labeling changes on the CCDS, and assist with the preparation of high quality documents to support the creation of the CCDS and/or changes to the local labeling for assigned projects or marketed products.
• Represent REGGL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) and work in close collaboration with the Global Regulatory Lead(GRL) and relevant line function expert(s) on creation/maintenance of core labeling documents. Participate on Partner Teams and present strategic global labeling issues to Regulatory Management on an ad-hoc/issue-driven basis for assigned projects/products.
• Provide strategic input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices.
Regulatory Labeling Activities:
• Global Product Information: Create and maintain regulatory compliant, competitive and up to date Company Core Data Sheets for assigned key development projects and marketed products. Ensure adequate reflection of key regional input (e.g. EU, US, International Markets) when developing or revising the CCDS.
• Prepare and manage International labeling including tracking differences in local labels to the CCDS, ensuring local requirements are met, and translations are properly executed.
• Labeling Supporting Documents: Organize/lead or contribute to the creation of high quality documents supporting changes to the CCDS or local labeling with internal and/or external experts including the preparation of responses to labeling-related Health Authority queries.
Present and defend proposed labeling changes in global product information documents, including labeling documents in key markets, to the Head of REG GL and other Senior Management as required for review and approval. Ensure that key country label proposals which deviate from a proposed CCDS or CCDS amendment/update (e.g., US PI, EU SmPC) are brought to the attention of the Head of REG-GL, together with rationale.
• Product Labeling Teams (PLTs):
- For CCDS creation/amendment resulting from cross-functional development, work closely with Global Regulatory Lead (GRL), (who is driving the coordination of the development of the dossier) and SMEs to obtain strategy plans, available data, and input to draft the CCDS.
- Organize and lead cross functional PLT meetings (including experts from Regulatory, Clinical, Safety, Technical Operations, Supply Chain, Pharm Tox, REG CMC, etc.) to reach consensus on global labeling matters and lead subject matter experts in the preparation of supporting documents for CCDS changes.
- Lead PLT meetings to review HA-requested labeling deviations for potential impact on the CCDS or local labeling and manage the preparation of an appropriate labeling response document in coordination with the local regulatory content manager. Present HA-requested deviations with an impact on the CCDS to the REG Sub Teams and other functions as applicable.
• Interactions with RA worldwide: Interact with Regulatory International and regional Partners to ensure timely implementation of global labeling changes in local product information, international consistency with the company’s position defined in the CCDS and as established by the PLT, and compliance with local labeling regulations. Guide/ support REG International for all labeling related HA negotiations and participate in labeling negotiation meetings or teleconferences with HAs, as needed. Assess country-specific deviations from the CCDS for assigned key development projects and marketed products.
• Regulatory Reporting: Provide RA input to Periodic Safety Update Report (PSUR) and Annual Reports for assigned products.
• Launch/Implementation: Review final artworks approve new or revised labeling to be implemented into production. Approve all change requests for revised labeling for assigned projects/products. Provide Supply Chain and QA guidance on labeling implementation requirements.
Excellence and Compliance:
• Contribute to global labeling management and continuous improvement initiatives. Review and comment on emerging internal and external guidelines and regulations on regulatory, safety, and legal topics.
• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes.
• Mentor newcomers and less experienced Labeling Associates and Managers
8+ years required of industry experience and extensive experience (at least 3 years) in global labeling, alternatively extensive experience in related areas of the Pharmaceutical Industry or Health Authorities.
•Experienced leader with management and direct reports.
•Experience negotiating with internal and external stakeholders on complex regulatory issues of importance to BioMarin.
•Outstanding interpersonal and communication (written and verbal) skills.
•Attention to detail and highly organized.
•Thorough understanding of regulatory labeling requirements and strategic labeling planning.
•Prior experience leading cross functional teams.
•History of solving regulatory labeling related problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
•Fluency in English as business language, additional languages advantageous.
•Global labeling experience and managing international teams.
•Rare disease experience is desirable.
•US, EU and International experience preferred.
Minimum requirements Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
This position may have direct reports.