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Associate Director, Regulatory Affairs Labelling, Strategy and Operations
Responsibilities will include, but are not limited to, the following:
• Maintain knowledge of current and proposed regulatory requirements regarding EMA labeling and ensure that Celgene is aware of changing requirements.
• 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 industry association involvement on labelling topics, e.g. with EFPIA, DIA, LabelNet and other groups as necessary.
• Accountable for group compliance with regulations and guidances related to labelling procedures and compliance with Celgene SOPs and working practices.
• Responsible for design and implementation of EMEA 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.
• Responsible for ensuring a consistent approach across all projects through monitoring team activity.
• Accountable for the interaction between the group and Affiliate Regulatory Affairs ensuring that local labelling complies with the Company Core Data Sheet (CCDS), deviations are identified and managed appropriately and all parties are informed and updated on a timely basis.
• Accountable for the interaction between the group and Global Labelling, ensuring appropriate EMEA input into global processes, CCDS changes and global understanding of EMEA procedures and regulations. May participate in global labelling strategy meetings.
• Assist Global/Regional Regulatory leads with development, quality control and submission of labelling to ensure compliance with new or revised CCDSs and associated CCDS implementation plans.
• Manage labels during product development to ensure ongoing alignment with clinical, regulatory, and commercial strategies.
• 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.
• Act as the Subject Matter Expert for readability testing and oversee readability and bridging projects as required.
• Lead development of labelling negotiation strategies, including discussions with EMA (QRD, CHMP, PIQ teams).
• Ensure timely provision of translations of Commercial labelling documents in the EMEA to health authorities and Celgene internal parties (e.g., Regulatory Leads, Regulatory Operations, Supply Chain Management, Technical Operations).
• Manage & coordinate pre- and post-approval labelling translation, in compliance with EU/International guidance, including exchanges with EEA Health Authorities (and liaison with Middle East & African authorities when required).
• Monitor the quality of the language versions of the labelling provided to Health Authorities, identify translation issues and work to design and implement new labelling translations development, review and approval procedures.
• Contribute to cross-project language harmonisation (semantic, sentence structure and style).
• Review and monitor change control workflows for updates to labelling text and artwork for multiple products marketed across the globe.
• Proactively identify potential issues and escalate to management for resolution.
• May have responsibility for the development, maintenance and global implementation of company core labeling for mature product(s).
• May have responsibility for the development, maintenance and global implementation of core patient information leaflet.
• Will be accountable to Global labeling for global responsibilities.
• Oversee maintenance of regulatory labelling and artwork repositories within the electronic document management system.
• Accountable for the archiving of packaging artwork, including vial and container labels.
• Responsible for leading, managing, developing and coaching the regulatory labelling and translation team.
• May mentor other RA team members.
• Will be a member of the RA EMEA Franchise Leadership Team.
• Develop vendor strategy and preferred suppliers (where appropriate) for user testing, translation services and linguistic tools.
• Oversee the development and management of suppliers/consultants for labelling and translation services ensuring projects are completed within budget.
• Encourage external vendors to provide Celgene with updates to local regulatory requirements.
• Responsible for resource planning and the assessment of workload and to alert RA Management in the case of predicted resource shortage.
• Responsible for the identification of budget requirements and budget management for the Labelling function.
• Extensive knowledge of drug development, regulatory submissions and approval processes, including labelling requirements throughout the product lifecycle.
• In-depth knowledge of health authority labelling regulations in Europe 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
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