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Technical Regulatory Affairs' Manager

Actalent

Posted on Jun 18, 2022 by Actalent

Basel, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

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, ...)

Candidate requirements:

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.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to the website.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.

Reference: 1634462621

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