CMC Regulatory Manager

CMC Regulatory Manager

Randstad Professionals are one of the leading recruitment companies in Switzerland and with a dedicated IT contracting team in Zurich. We are excited to help you in your search. We focus on finding the best contracts for the best contractors.

Currently we are looking for a CMC Regulatory Manager, for a minimum 6 month contract, to join our client's team in Basel.

Responsibilities:

- The CMC Regulatory Manager in Small Molecules Marketed will be responsible to support global CMC regulatory teams to help write CMC sections of our client's post-approval marketing applications, support renewal and answers to deficiency letters
- The individual will support and facilitate review of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents
- The individual will support Technical Regulatory Leader to maintain system and databases

Qualification:

- The candidate must possess a University degree in chemistry, pharmacy, life sciences or equivalent
- 2 years or more experience in pharmaceutical CMC regulatory affairs, formulation development, quality, or analytical development is required; experience post-approval submission is advantageous
- Must be detail oriented with excellent interpersonal skills
- Good English-language speaking and written skills are required

Whether this role is the right fit or you would like to see if there are others that do, our dedicated and expert team is looking forward to hearing from you.

Good to know you!