After achieving exciting milestones in 2019 and securing funding to further develop novel therapeutics, a small bio-pharmaceutical company has an opportunity for an initial 6 month project for an experienced Regulatory Affairs Manager. The role will be located in the Zurich region.
- Provide expert knowledge on regulatory requirements and demonstrable submission authorship experience
- Working closely with the Head of CMC to ensure the timely completion of submissions for relevant regulatory bodies EU / FDA.
- Liaise with Head of CMC and development team to ensure technical CMC requirements in International countries are adhered to
- Keeping internal stakeholders and investors abreast of regulatory changes and how they may impact the project
- Respond to Health Authority queries with support and direction from Head CMC
- Contribute to the overall strategy by defining and executing the regulatory pathway
Qualifications and Experience:
- Minimum 4 years of experience in International Drug Regulatory Affairs roles on a senior level, within the pharmaceutical industry;
- Scientific background needed – Education (BSc/MSc) in biology, biochemistry or other relevant scientific background;
- Good practical experience of health authorities management and global regulatory processes;
- Experience working in a flexible manner in a small company
- Proactive approach to overcoming challenges
- Fluency in written and spoken English, German is an advantage
- Experience in early stage development context is an advantage
- Relevant Swiss working permit required
It’s people that deliver projects and with over 60 offices in 33 countries, at NES Global Talent we have access to the best talent wherever it may be in the world. To apply for this role, please send your CV to Kevin Kendaru, firstname.lastname@example.org.