Regulatory Affairs CMC Associate Manager

  • Contract type Temporary Assignment - 18 months
  • Place
    Basel
  • Reference manager-2343-563969
  • Assignment start date 13.02.23
  • Sector Chemistry & Life Sciences
  • Publication date 17.01.2023
  • Apply

For our client, a leading pharma company in Basel, we are looking for a Regulatory Affairs CMC Associate Manager to start asap.

Regulatory Affairs CMC Associate Manager

Your assignment

As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high-quality CMC (Chemistry, Manufacturing, and Control) regulatory documentation for our products and contribute to global regulatory submissions and strategies.

Your profile



- Author high-quality global CMC documentation for regulatory submissions throughout the product lifecycle for Biologics projects/products.
- Apply agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Coordinate, collect, store source documentation needed for direct submission to Health Authorities.
- Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.




- Good oral and written communication skills with a collaborative and patient-focused mindset.
- Ability to work successfully with global project teams and prioritize activities considering timelines and workload.
- Well-developed planning, organizational, negotiation, problem solving and interpersonal skills.
- Computer/IT systems literacy.
- Degree in Science (e.g. Biochemistry, Biology, Biotechnology, Chemistry, Pharmacy) or equivalent.
- Advanced Degree in Science desirable.
- Experience in regulatory and/or in the pharmaceutical industry preferred
- Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the drug development process desirable.
- Swiss and/or EU/EFTA nationality, or a valid work permit for Switzerland.

Interested?

We look forward to receiving your application via the online application form.

About Manpower
Manpower Switzerland offers its customers more than 55 years of experience in the recruitment, selection and placement of permanent and temporary staff, as well as in HR solutions. Its network of 50 branches active in all linguistic regions, 20,000 temporary staff, 1,500 permanent placements and over 5,000 clients – including small, medium and large companies – in all sectors of industry make Manpower one of Switzerland’s leading providers of workforce management solutions.
 
Our 3 promises
“We are passionate about what we do. This passion is a motivating and driving force, ensuring excellent placement opportunities for you.”
“We care about the people we work with. Including you. That’s why our collaborations are based on trust.”
“We take on our responsibilities. For you, that means security and exciting prospects.”
 
 

I'd like to apply

Your Manpower consultant
Lauriane Cotter

Life Sciences Competence Center
Elias-Canetti-Strasse 2
Zurich

T: +41 58 307 2441



Speculative application

Haven't found what you're looking for? Send us a speculative application, and we will get in touch as soon as we hear of an opportunity for you!

Apply
Display shares