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Finding the ‘Needle in the Chaystack’ Talent#RegulatoryAffairs
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr