Regulatory CMC Manager

Finding the ‘Needle in the Chaystack’ Talent#Regulatory Affairs

This is an exciting opportunity to support a Pharmaceutical companies global regulatory affairs activities focusing on CMC.

This is an On-site role, in Germany requiring English language skills, see below for more information:

Manage and oversee regulatory post approval Chemistry, Manufacturing and Controls (CMC) changes involving deliverables such as:

• Provide of regulatory evaluation of change controls and regulatory strategy
• Monitor timely submission and approval in affected countries
• Manage and coordinate responses to health authority questions
• Overall planning of all CMC regulatory changes per product together with relevant interfaces
• Authoring of Dossier sections – Module 2 and Module 3 – DS and DP
• Compilation of CMC documents for MAA, renewals, variations, commitments,
• Interaction and cooperation with experts from the relevant departments and CMOs, also in non-European countries, to compile the information and data required for Module 3.2.P.
• Interaction with competent authorities in the context of ASMF/DMF and CEP activities.

Minimum Qualifications:

• Bachelor's degree required in for Pharmaceutical: science, engineering, or related field
• 8 or more years in Regulatory CMC Lifecycle management
• English + German language skills (Business Proficient)
• Experience with national and global regulatory affairs activities.
• Experience in small molecules and biological products.

Seniority level:
Mid-Senior level

Employment type:

Full-time

Job function:
Science and Manufacturing

Industries:
Pharmaceutical Manufacturing and Biotechnology Research

Cologne, North Rhine-Westphalia, Germany 3 days ago