Director, Regulatory Affairs Labeling, Strategy and Operations - United Kingdom
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- Provides regulatory guidance and oversight of global labeling activities for assigned products. Serves as the Global Labeling lead on Company Core Data Sheets (CCDS) and labeling teams providing strategic input into the development and approval of CCDS, SmPC, and US prescribing information for assigned products.
- Will be accountable to the head of Global Labeling for Global Labeling responsibilities.
- This role is also an expert on all EU labeling requirements and the EMA centralized labeling and translation process and maintains an awareness of the impact on the Company of proposed regulatory changes. Responsible for leading, managing & developing the EMEA Regulatory Labelling and Translation team and ensuring that best practices are developed and implemented across projects.
- This person ensures that the group communicates effectively with the Affiliates and with global/regional central functions both within Regulatory Affairs and other departments.
- The individual will be a member of the EMEA Regulatory Affairs (RA) Franchise Leadership team.
- Responsibilities will include, but are not limited to, the following:
- Serve as a Global Labelling subject matter expert for all matters relating to the CCDS
- Maintain knowledge of US and EU labelling regulations and guidelines
- Partner with Global Regulatory Leads and CCDS teams to lead the development, approval and maintenance of CCDS for assigned products
- Review and assess impact of regulatory initiatives related to labelling (e.g. IDMP, Braille, packaging and labelling systems readability and user consultation); design, develop, and/or implement systems to comply with these initiatives.
- Lead, manage, develop and coaching the regulatory labelling and translation team
- Resource planning and assessment of workload
- Budget management
- Lead industry association involvement on labelling topics, e.g. with EFPIA, DIA, LabelNet and other groups as necessary
- Manage labels during product development to ensure ongoing alignment with clinical, regulatory, and commercial strategies
- Lead development of labelling negotiation strategies, including discussions with EMA (QRD, CHMP, PIQ teams)
- Chair cross functional labelling team meetings in order to prepare, maintain and finalise SmPCs, PILs, artwork, and responses to labelling-related health authority questions for both new MAAs and post marketing variations.
- Design and implement best practices for the development of new labeling review and approval procedures and evaluation of existing procedures for practical application. Expected to participate in and contribute to global processes
- Ensure team compliance with regulations and guidance related to labeling procedures and compliance with company Policies, SOPs, and working practices.
- Ensure that European labeling complies with the CCDS and deviations are identified and managed appropriately
- Ensure appropriate EMEA input into global processes, CCDS changes and global understanding of EMEA procedures and regulations.
- May participate in global labeling strategy meetings.
- Ensure timely provision of translations of Commercial labeling documents in the EMEA to health authorities and company internal parties (e.g., Regulatory Leads, Regulatory Operations, Supply Chain Management, Technical Operations).
- Manage and coordinate pre- and post-approval labeling translation, in compliance with EU/International guidance
- Ensure quality of the language versions of labeling provided to Health Authorities
- Review and monitor change control workflows for updates to labeling text and artwork
- Oversee maintenance of regulatory labeling and artwork repositories within the electronic document management system.
- Ensure archiving of packaging artwork, including vial and container labels
- Ensure suppliers and consultants for labeling and translation services complete projects according to quality standards, and within budget
- Extensive knowledge of drug development, regulatory submissions and approval processes, including labeling requirements throughout the product life-cycle.
- In-depth knowledge of health authority labelling regulations in Europe, US, and ROW.
- Writing, editing, and proofreading skills, with attention to detail.
- In-depth knowledge of labelling layout and design.
- Demonstrated ability to lead and/or interact effectively with cross-functional teams and regulatory agencies.
- Flexibility to adapt to changing project priorities and work assignments
- Project management and organizational skills
- The ability to work under strict timelines
- Excellent knowledge on English; knowledge of at least one other languages preferred.
- Demonstrated ability to interact effectively with vendors and regulatory agencies
- Proven Management experience
- Ability to lead and mentor junior staff as needed
- Scientific background desirable.
- Excellent written and verbal communication skills