Regulatory Affairs Specialist
Posted on May 26, 2022 by Actalent
This is your chance to join a fast-growing and dynamic company to support its new project and be a well-established team. Fluent English is a must.
- Write and update Module 2 (Quality Overall Summary) and the Module 3 (drug substance and drug product quality sections) of the CTD/NDA Applications
- Write and update the Quality part of the IMPD/INDs for clinical trials applications (Entry to Man, up to Phase III studies)
- Evaluate the regulatory impact of the technical changes as well as the investigations needed before implementation. Prepare the new registration documents.
- Support and advise the project team regarding pharmaceutical development related to regulatory strategy for submission.
- Prepare the answers to the CMC questions raised by the Health Authorities following the submission of Marketing/Clinical Trial Applications and technical variations
- Prepare Briefing Books and supportive documentation for Health Authority meetings (pre-IND, pre-NDA, End of Phase II, Scientific Advice meetings)
- Attend Health Authority meetings to discuss pharmaceutical development related to regulatory strategy for submission.
- Ensure consistency between raw data and registration documents contents
- Provide assistance to Quality Assurance in ensuring the company's compliance with GMP and regulatory guidance (ICH, FDA, EMA, PMDA, ...)
- University degree (MSc, PhD) in Chemistry or Pharmacist (Pharm D) or biology
- Knowledge of, and understanding of ICH guidelines (Quality)
- Minimum of 3-5 years experience in technical regulatory affairs (CMC writer of Quality sections of IND/IMPD/NDA/CTDs)
Job Title: Regulatory Affairs Specialist
Location: Basel, Switzerland
Rate/Salary: 50.00 - 55.00 CHF Hourly
Job Type: Contract
Aerotek, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on the website.
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