Are you a seasoned professional in the field of Regulatory Affairs CMC? We have a fantastic opportunity for a Senior Manager to join one of the best companies within the industry!

About the Role:

As the Senior Manager Regulatory Affairs CMC, you will play a crucial role in providing European regulatory guidance and strategy. Representing the Regulatory Affairs CMC EU division, you will engage in internal and external interactions, collaborating with global and local project teams, authorities, and contract manufacturing organizations (CMOs). Your expertise will be instrumental in ensuring the development and life cycle management of our products aligns with regulatory CMC standards, scientific soundness, and commercial viability.

Key Responsibilities:

• Prepare and review regulatory CMC documents during development and life cycle management
• Act as the CMC regulatory guidance and strategy expert in global teams
• Support Health Authority meetings and lead responses to information requests
• Stay updated on regulatory and scientific regulations, communicate changes, and review dossiers and technical documents
• Collaborate companywide with the global RACMC department and technical functions

Desired Skills and Experience:

• Master’s degree in Life Science or Pharmacy (PhD preferred); Regulatory Affairs qualification is a plus
• Minimum of 5 years of experience in the pharmaceutical industry
• Strong background in global regulatory affairs CMC, particularly in late-stage drug development, life-cycle management, or marketing authorization applications in Europe (experience in biologics is preferred)
• Proven ability to coordinate and lead multiple projects simultaneously
• Excellent interpersonal and intercultural skills, with the ability to work cross-functionally in a multinational organization
• Proficiency in English (German as a second language preferred)
• Solution-oriented, detail-oriented, well-organized, and self-motivated
• Strong working knowledge of Microsoft Office

Apply Now:

If you are ready to take on this exciting opportunity and contribute to the success of our client, we would love to hear from you! Please submit your application with your updated CV to george.creed@albionryeassociates.com