Technical Regulatory Affairs' Manager
Posted on Jun 18, 2022 by Actalent
TECHNICAL REGULATORY AFFAIRS MANAGER
A top pharmaceutical company in the Basel area is looking for someone to join their Regulatory team to work on a cutting edge product. Experience within CMC and product development is needed to thrive in this position.
The responsibilities include:
Write and update the Module 2 (QOS) and the Module 3 of the Clinical Trial Documents and New Drug 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 compliance with GMP and regulatory guidance's (ICH, FDA, EMA, PMDA, ...)
Higher degree in Life Sciences (Pharm D preferable)
Minimum of 3 years' experience in technical regulatory affairs and CMC
Experience with the writing of Quality and Regulatory documents
Fluent written and spoken English skills
If interested please apply or reach out directly to (see below)
Job Title: Technical Regulatory Affairs' Manager
Location: Basel, Switzerland
Rate/Salary: 60.00 - 65.00 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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