Manager Regulatory Affairs (m/w) 100%

Our client is a global pharmaceutical leader focused on advancing innovative therapies and ensuring patient access. They are seeking a Manager Regulatory Affairs to support and lead regional teams (Europe & Canada [EUCAN] or Growth & Emerging Markets [GEM]) in regulatory strategy and product life cycle management.

Description

The selected candidate will be responsible for the following task area:

• May be regulatory lead or support a more senior regulatory lead for assigned assets and/or projects
• 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
• Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required
• Supports Access to Medicines initiatives to develop and implement innovative patient access strategies
• Providing regulatory guidance throughout product development and life cycle phases
• Monitoring regulatory changes and adapting strategies accordingly
• Collaborates with the Regional counterparts, Local Regulatory Affairs, to manage all aspects of regulatory activities throughout the product life cycle

Profile

To be considered for this position, the ideal candidate must have:

• 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
• Detail-oriented with strong analytic and communication skills
• Able to manage priorities flexibly and work independently
• Fluent in English

Job Offer

Are you looking to add significant value in an international environment and play a key role in an exciting project? Then apply today!