This is an exciting opportunity to support a Pharmaceutical companies global regulatory affairs activities focusing on CMC.
This is a On-site role, in Germany requiring English language skills, see below for mor 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.