Regulatory Affairs Manager
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.
- Advising 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 within the 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 optimise product development
- 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
Skills and Requirements
- Relevant experience with regulatory activities in the EU region including clinical trials (CTAs) and registration procedures
- 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
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.