SUMMARY

This position will be responsible for leading the development, review, and management of US, EU, and International labelling for commercial products.  The incumbent will be responsible for assessing and managing labelling changes for lifecycle products and develop new labelling for new products in pre-approval stages. The Reg Global Labelling Manager (GLM) will ensure the appropriate labelling strategies are communicated to project teams; compliant with core labelling and local regulations; ensure the labelling 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.  

RESPONSIBILITIES

This position will be responsible for:

1. The GLM leads the assigned product labelling teams (PLTs) and supports labelling positions.
2. Close collaboration with subject matter experts on the PLT, Global Regulatory sub-teams, and Senior Management Review Teams to ensure the execution of global regulatory labelling plans are aligned with the global regulatory strategy and with BioMarin’s labelling processes and standards.
3. Preparation of labelling content based on source documents such as CSRs, regulatory requirements and other reference documents. 
4. Review worldwide labelling against the Core Safety Information and facilitate and track implementation of changes to align with core content.
5. Facilitate the review and approval process within the product labelling teams, including outlining the label history and documentation of team decisions. Provide and maintain background documents outlining the purpose and justifications for labelling changes. This includes local labelling content and global labelling content (CCDS).
6. Manage approved labels in a label management database/corporate system to ensure accurate and up to date labelling is available and accessible at all times.
7. Maintain knowledge of current rules and regulations governing global labelling activities.
8. Receive and collate labelling text from labelling team members and manage labelling content and revision control. Assess text for compliance with labelling requirements and provide team recommendations on appropriate text for labelling content.
9. Reviewing and approving artwork and change control related to labelling activities.
10. Supporting launch and/or release of revised labelling into production.

Regulatory Labelling Strategy:

• Prepare labelling strategy, reach consensus on global labelling matters, assess impact of regional/local labelling 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 labelling 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 labelling documents. Participate on Product Core Teams and present strategic global labelling issues to Regulatory Management on an ad-hoc/issue-driven basis for assigned projects/products.
• Provide input on interpretation and implementation of key regional labelling regulations, guidelines, and best labelling practices.

Regulatory Labelling Activities:

• Document control and distribution of product labels (prescribing information, carton and container labelling) including drafting initial documents, annotations, generate and review of SPL files, prepare final labelling.
• Project management role of logistical activities and delivering labelling 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 labelling 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 labelling 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 labelling regulations. Guide/ support REG International for all labelling related HA negotiations and participate in labelling 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 labelling to be implemented into production. Approve all change requests for revised labelling for assigned projects/products. Provide Supply Chain and QA guidance on labelling implementation requirements. Support first launch into new markets.

Excellence and Compliance:

• Contribute to global labelling 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.

EXPERIENCE

Required Skills:

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 labelling submissions and related activities
• US and/or EU Labelling experience minimally required and core labelling 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 labelling, proven experience in drafting labelling content
• Experience with E2E global labelling processes and management of Company Core Data Sheets
• Experience in review process, standards, and industry best practice pertaining to labelling
• 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 labelling
• Experienced processing and assessing translations of labelling 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

Desired Skills:

• International labelling experience including Latin America, APAC Regions, and MENA CIS Regions desirable.

EDUCATION

Minimum requirements BS or MS with requisite experience and demonstrated capability. Science or medical background and advanced degree (MD, Ph D, PharmD) desirable.

Location: London with flexible home working