Regulatory Affairs CMC Consultant

For our client, a biopharmaceutical company based in the Zurich area, we are looking for a Regulatory Affairs CMC Consultant to begin a one-year contract.

Key Responsibilities

- Compile and review applications for development and marketed products including CTD modules 1-3, IMPDs, MAAs...
- Review Module 3 submissions/responses to health authority questions from EMA and other ex-US agencies.
- Prepare and review Module 1 and other regulatory administrative parts of submissions to EMA and other relevant ex-US agencies.
- Conduct regulatory impact assessment of planned CMC changes (change control system), compile modules 1-3 for variation filings, finalize timelines, execute the regulatory task by driving the variation submission until approval thus ensuring post authorization regulatory compliance on European marketing authorisations.

Ideal Profile

- 5-10 years of successful Regulatory Affairs experience, including European and other ex-US achievements with Regulatory Affairs CMC
- Thorough practical experience with and knowledge of the Commission Regulation on variations of marketing authorisations
- Successful experience associated with maintenance and commercialization of medicinal products

If you match the above skill set I look forward to receiving your application via this website.

Please note that due to visa regulations we can only consider EU/CH nationals.