Please refer to JobSuchmaschine in your application
CMC Regulatory Affairs Manager
Amaris is an independent and international Consulting Group specialized in Management and Technologies.
Amaris operates in over 45 countries delivering services in Business & Management Consulting, IT/Information Systems, Telecommunications & Networking, Engineering, Pharmaceutical & Biotechnology.
Since 2007, the company has grown exponentially and is committed to building lasting relationships with its clients, delivering innovative solutions from project inception to execution.
We are looking for a CMC Regulatory Manager in Small Molecules who will
be responsible to support global CMC regulatory teams,will help writing CMC sections of post-approval marketing applications, support renewal and answers to deficiency letters.
The candidate will support and facilitate review of submissions by collecting comments from the CMC team and reviewers, leading review discussions, modifying documents and will support Technical Regulatory Leader to maintain system and databases.
The candidate must possess an University degree in chemistry, pharmacy, life sciences, at least 3 years of experience in pharmaceutical CMC regulatory Affairs, formulation development,
quality or analytical development. Experience in post-approval submission is Must be detail oriented with excellent interpersonal skills
Fluent level of English required