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Regulatory Affairs Director CMC
As an expert in Regulatory Affairs, you have the exciting opportunity to take a key position for a company that is bringing cutting-edge therapies to patients that continue to suffer through less effective treatments and yet unmet needs. In this position, you will lead a dedicated Team within an established organization where quick decisions and an open-minded culture are valued and ensure that patients profit from innovative programs and treatments developed under the highest quality standards.
Our experienced and long-standing customer is continuously growing in Europe. To meet the highest demands of the European and North American market they are looking for an experienced personality to lead and oversee the Regulatory strategies and ensure Quality standards and regulations for submissions for CTAs and MAAs are met on the highest level.
- Manage and develop Regulatory strategies and advise on submissions of the local operations including full direction authority over all personnel responsible for quality and pharmaceutical measures in the EU and Canada
- Support global clinical trials, INDs and CTAs as well MAAs
- Serve as point of contact with regulatory authorities
- Representing Regulatory CMC on multi-disciplinary teams
- Master or Bachelors degree in life sciences, PhD, PharmD advanced degree preferred
- Several years of experience in Regulatory CMC affairs with exposure to EMA and FDA authorities
- Expertise and experience with centralized EU Procedure required (preferably MAA, or as a minimum, major Type II Variations for new indications)
- Experience leading a team to prepare for and carry out significant health authority interactions
- Business fluent in English and German
At headcount, we are a passionate team of scientists located in Zürich Switzerland, dedicated to finding exceptional candidates and leadership personalities for our selected clients and partners. It is our challenge to find candidates who not only meet but exceed the expectations of our partners in the pharmaceutical, biotechnology, and medical devices industry.
If you are meeting the requirements listed above, I am looking forward to a first exchange
Julian Nelle Talent Acquisition Consultant
+41 44 215 24 93 | +41 78 753 22 80
www.headcount.chDreikoenigstrasse 55, CH-8002