Associate Director - Product Lead China and GEM

Biogen ,
Maidenhead, Berkshire
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Job Description

The Associate Director - Product Lead China and GEM will be liaising directly with Biogen China regulatory and extended business teams up to and including Regional President, CRO/consultant stakeholders and development RDPL/PDC teams to ensure development and agency engagement strategies are developed for specific assets under responsibility (3/4 products).Reporting to the Director Emerging Markets APAC Regional Lead To inform and advise GEM product lead colleagues of China development and submission requirements and to ensure they remain aware/are updated of China activities for their assets To provide aligned "expert" guidance and insights of China development and submission requirements to PDC / RDPL lead groups and senior management and, where required, present to senior management groups (e.g PDC-OC) proposed cross line agreed regulatory/clinical strategies for assets under responsibility. To drive development and execution of Agency Engagement and submissions strategy working in collaboration with Regional Lead, China RA team, regional commercial leads and asset team stakeholders To represent Global regulatory as Regional/China at agency meetings in collaboration with local RA colleague as required. To be the Emerging Market Product Lead for defined products and to ensure GEM product strategy is factored into Global Product Development Strategy Accountability Description Strategic Planning & Guidance: As CHINA Product Lead ensure development, challenge, validation, communication and execution of new product and lifecycle regulatory strategies for products under responsibility, in collaboration with regional stakeholders including commercial, market access, medical and global stakeholders leads. Lead regulatory activities to ensure early stage development requirements highlighted and considered by RDPL/PDC teams , as part of development and submission strategy. Strategy Execution : As CHINA Product Lead to engage with asset team subject matter experts to oversee, direct and steer preparation of China specific briefing documents, supporting documentation and resource planning. To ensure development, discussion and cross line agreement of nascent regulatory/development strategies and support of subsequent endorsement discussion with senior stakeholders including PDC-OC Strategic Engagement: As China Product Lead seek to identify opportunities to build and enhance relationships with key external stakeholders and Regulatory Agencies in alignment with Regional Team (UK/China) and Reg. Policy. Ensure Regulatory representation and Biogen policy aligned input to country industry associations, whilst ensuring alignment with local business colleagues. RDPL/PDC Strategic Support: As GEM PRODUCT LEAD responsible for directing and providing consolidated Global Emerging Markets input and insight to development teams, to ensure GEM has a voice and GEM development considerations are considered as part of the development program. Responsible for gaining agreement for submission prioritization and resourcing with the PDC, working closely and directing GEM regional colleagues and for oversight of GEM submissions.- Minimum 5-7+ years pharmaceutical/biotechnology industry experience in Regulatory Affairs -with Extensive European Regulatory Development experience AND experience in Emerging Markets. (ASIA/PAC ideally) - Comprehensive knowledge of global and emerging market trends and broad requirements. - Experience in interpretation and communication of global and emerging market regulations, guidelines, policy statements, etc. - Experience and knowledge in the preparation of emerging market assessment of major regulatory submissions, variations or supplements. - Significant experience in interfacing/engagement with Regulatory Authorities or policy makers- Minimum BA/BS/University degree required, Life/Health Sciences preferred. Employment Type: Full-Time_Regular

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