Regulatory Affairs Manager

For our client, an international company in Zürich, we are looking for a Regulatory Affairs Manager.


General Information: 

• Start date: ASAP
• Contract: temporary via Randstad
• Duration: until 31/03/2026
• Extension: possible, to be discussed
• Workplace: Zürich
• Workload: 100%

Tasks and responsibilities:
 

• Demonstrates leadership behaviors.
• 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 Access 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.

Your Profile:
 

• 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 as well as leading interaction with Health Authorities.
• Has basic regulatory procedure knowledge with major health authorities in the region.
• Analyzes issues with attention to detail and makes reasoned recommendations.
• Promotes an inclusive culture and expresses empathy for others.
• Is able to carry out assigned activities within reasonable time
• Adapts to changing circumstances and is able to build and maintain relationships.
• Receives and gives feedback; expresses ideas, questions, and disagreement.
• Is self-aware and able to function effectively while meeting the multiple challenges of daily life with a sense of energy, vitality, and confidence.
• Fluent in English.