Manager Regulatory Affairs 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:

• Supporting the development and execution of regional regulatory strategies to ensure timely approval of investigations and marketing applications • Collaborating with global and local teams to maintain compliance and optimise patient access • Leading or assisting in submission working groups and representing the region in cross-functional teams • Managing Health Authority communications and submissions in the assigned region • Providing regulatory guidance throughout product development and life cycle phases • Monitoring regulatory changes and adapting strategies accordingly • Supporting internal process improvements and post-marketing commitments tracking • Facilitating patient access initiatives and maintaining strong stakeholder relationships • Preparing and leading Health Authority meetings and follow-ups

Profile

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

• Bachelor's degree in a scientific or related field preferred; relevant experience considered
• Minimum 4 years regulatory affairs experience, ideally in EU and/or GEM markets
• Knowledge of advanced therapies (e.g., cell & gene therapy) beneficial
• Experience managing regulatory submissions and Health Authority interactions
• 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!