Freelance Consultant Local Regulatory Manager (m/w/d)

We are seeking a motivated Regulatory Affairs Specialist to join our client's team and support their growth.

Key Responsibilities:

• Prepare and execute global regulatory strategies in collaboration with the regulatory affairs team.
• Provide regulatory expertise and guidance to project teams, supporting product development and life-cycle management.
• Interact with national/regional regulatory agencies, participating in meetings and preparing submission packages.
• Prepare, review, and consolidate relevant technical information for regulatory dossier submission.
• Offer regulatory expertise for the EMEA and Swiss (Swiss Medic) region, advising on specific requirements and supporting regional activities.
• Monitor global and EMEA health authority regulations to ensure compliance and proactively address regulatory challenges.

Education and experience :

• Minimum Bachelor in life sciences, Master are welcome
• 3+ years of regulatory affairs experience in Pharmaceutical industry
• Experience in EU and Swiss regulatory affairs is a must, and in global regulatory affairs is a plus
• Experience in overall drug development processes and strategies a must, in biologics is a plus

Personal qualities:

• Excellent Strategic skills
• Good English written and verbal communication skills - French or German a plus
• Ability and willingness to work collaboratively with global team members across multiple time zones (US, APAC, EMEA)
• Ability to prioritize competing timelines / projects
• Analytical and problem-solving skills