Regulatory Affairs Manager m/f/d, ZürichContributes to define, develop, and support the Regional [(Europe & Canada [EUCAN] or Growth & Emerging Markets [GEM]) strategies to maximize regulatory success and strengthen the product development plan in support of enabling patient access, including all aspects of submission and timely approval of investigational applications, market application and life-cycle management
Collaborates with the global, regional, and local team to enable patient access in alignment with program objectives and timely approval of investigational applications and life-cycle management applications, while maintaining full compliance with applicable regulatory requirements.
Location: Opfikon
Contract start date: As soon as possible
End date: 31.03.2026
Responsibilities: - Collaborates with Global, Regional counterparts, Local Regulatory Affairs, to manage all aspects of regulatory activities throughout the product life cycle.
- May be regulatory lead or support a more senior regulatory lead for assigned assets and/or projects.
- May present regional regulatory strategies to leadership/senior management
- Stays current with regulations / guidance in the region for impact on drug development plans, registration, and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain regulatory compliance.
- Provides regulatory expertise on drug development, registration and / or post-marketing compliance and life cycle management.
- Monitors the relevant regional regulations /guidance for programs in area of responsibility
and participates in the review of new legislation and regulatory procedural guidelines, as applicable. - Participates, as appropriate, and authors/reviews internal procedures and processes.
- Actively pursues the tracking and fulfillment of post marketing commitments.
- Understands and interprets complex scientific issues for products of responsibility as it relates to regulatory requirements and strategy.
- Supports Acce.ss to Medicines initiatives to develop and implement innovative patient access strategies
- Develops effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross- functional Teams; company's consultants and Business Partners as required.
- Effectively communicates the regulatory strategies, submission plans and timelines, probability of success, and impact assessments of trends, regulations and changes related to assigned programs.
- Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
- Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed
- Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required.
- Oversees LOC interactions with Health Authorities in Growth & Emerging Markets for responsible programs.
- Interacts directly with HA (EUCAN), as required.
- May represent the company in Health Authority meetings. Effectively communicates and manages meeting outcome and next steps, as required.
Requirements: - BSc. Advanced scientific related degree preferred; BA accepted based on experience.
- A minimum of 4 years of experience in drug regulatory affairs preferably within the EU/GEM region.
- Experience with advanced therapeutic medical products (Cell & gene therapy) will be advantageous.
- Solid regulatory experience, including knowledge of regulations and guidance governing drugs and biologics in all phases of development for [Emerging markets and/or EUCAN Markets (relevant to role)] as well as leading interaction with Health Authorities.
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