Associate Director, Regulatory Global Labeling
This position will be responsible for leading the development, review, and management of US, EU, and International labeling for commercial products. The incumbent will be responsible for assessing and managing labeling changes for lifecycle products and develop new labeling for new products in pre-approval stages. The Reg Global Labeling Associate Director will ensure the appropriate labeling strategies are communicated to project teams; compliant with core labeling and local regulations; ensure the labeling is accurate and of the highest quality; and support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status.
This position will be responsible for:
- Close collaboration with subject matter experts on the Product Labeling Team (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.
- Preparation of labeling content based on source documents such as CSRs, regulatory requirements and other reference documents.
- Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content.
- Facilitate the review and approval process within the product labeling teams, including outlining the label history and documentation of team decisions. Provide and maintain background documents outlining the purpose and justifications for labeling changes. This includes local labeling content and global labeling content (CCDS).
- Manage approved labels in a label management database/corporate system to ensure accurate and up to date labeling is available and accessible at all times.
- Maintain knowledge of current rules and regulations governing global labeling activities.
- Receive and collate labeling text from labeling team members and manage labeling content and revision control. Assess text for compliance with labeling requirements and provide team recommendations on appropriate text for labeling content.
- Reviewing and approving artwork and change control related to labeling activities.
- Supporting launch and/or release of revised labeling into production.
Regulatory Labeling Strategy:
- Leads the Product Labeling Team (PLT), a cross-functional, global team formed to ensure appropriate subject matter expertise is provided in the label development.
- Advising teams on the degree of data and evidence required to support labeling claims in close collaboration with the appropriate Regulatory stakeholders
- Prepare 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 REG GL 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 Product Core Teams and present strategic global labeling issues to Regulatory Management on an ad-hoc/issue-driven basis for assigned projects/products.
- Interact with Global Regulatory Affairs International and regional Partners to ensure timely implementation of global labeling changes and new market submissions and approvals
- Guide launch teams on label requirements and considerations as part of the launch strategy for new commercial products
- Attend Label Implementation Planning Team (LIP) and provide Supply Chain, QA and other SMEs guidance on labeling implementation requirements, as required
Regulatory Labeling Activities:
- Manage the review of final artworks and approval new or revised labeling to be implemented into production. Manage the approval all change requests for revised labeling for assigned projects/products. Provide Supply Chain and QA guidance on labeling implementation requirements. Support first launch into new markets
- Document control and distribution of product labels (prescribing information, carton and container labeling) including drafting initial documents, annotations, generate and review of SPL files, prepare final labeling.
- Project management role of logistical activities and delivering labeling documents within agreed timeframes. 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.
- Manage translations and address discrepancies with local partners and linguistic experts, ensuring alignment with source content.
- 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. Support first launch into new markets.
- Oversee vendors that are contracted to perform any Global Labeling activities
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.
4-6 years, or 2-4 years with Advanced Degree (Masters, PhD, MD), 2+ years in Regulatory Affairs.
- Regulatory Affairs experience is essential with direct experience managing labeling submissions and related activities
- US and/or EU Labeling experience minimally required and core labeling experience highly desired
- Experience and working knowledge with SPL and PLR requirements and/or SPC/PIL and QRD requirements
- Excellent writing skills especially suitable for labeling, proven experience in drafting labeling content
- Experience with E2E global labeling processes and management of Company Core Data Sheets
- Experience in review process, standards, and industry best practice pertaining to labeling
- Strong scientific background and/or experience
- Working knowledge of medical terminology and drug safety
- Proven project management, leading teams from multiple functional areas
- Highly organized with the ability to manage complex projects and timelines for all aspects of E2E labeling
- Experienced processing and assessing translations of labeling a plus.
- Excellent verbal and written communication skills; strong technical writing and presentation skills
- Must be able to work as a team member and independently
- Strong attention to details required and high-quality work
- Fluency in English as business language, additional languages advantageous
- Ability to travel (up to 15%) for industry conferences or other business meetings
- Flexibility to work occasional nights and weekends as determined by critical Regulatory deadlines
- International labeling experience including Latin America, APAC Regions, and MENA CIS Regions desirable.
Minimum requirements BS or MS with requisite experience and demonstrated capability. Science or medical background and advanced degree (MD, Ph D, PharmD) desirable.