The Regulatory Affairs Manager will support one or more products from a regional regulatory perspective. The Regulatory Affairs Manager will be working with cross-functional teams, including those in Development, Medical, Commercial, and Value and Access. As a member of the Global Regulatory Team (GRT), the Regulatory Affairs Manager will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
Key responsibilities include:
• Advising the GRT on regional regulatory considerations in developing strategy
• Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
• Under general supervision, planning and managing regulatory submissions (e.g. clinical trial and marketing applications) for products withinthe company's portfolio in compliance with global filing plans and local regulatory requirements.
• Under general supervision, developing and/or implementing innovative and compelling regulatory strategies designed to enable patient access, following regulatory affairs processes and activity planning in accordance with national legislation and regional regulatory requirements.
• Under general supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
• Leading development of regional regulatory documents and meetings in accordance with the regulatory strategy
• Providing regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, PRIME, compassionate use and paediatric plans)
• Directing the development of the regional product label by collaborating with internal stakeholders to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
• Managing regional label negotiation activities
• Identifying and mitigating regulatory risks and support contingency planning
• Acting as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment •
• Documenting and communicating details and outcomes of regulatory agency interactions to GRT and relevant Sr. Management
Knowledge and Skills:
• Relevant experience with regulatory activities in the EU region including clinical trials (CTAs) and registration procedures (MAs, post approval changes, extensions and renewals).
• Good knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Ability to anticipate regulatory agency responses to strategy
• Awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
• Experience with EU and national legislation and regulations relating to medicinal products
• Ability to understand and communicate scientific/clinical information
• Cultural awareness and sensitivity to achieve results across both regional country and International borders.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.