Regulatory Affairs Manager (m/f/d)
Responsibilities
- Maintenance of Swiss registration files and DMF drug products in the USA and Canada
- Coordinate with partners’ regional regulatory teams for global strategy
- Act as liaison with Swissmedic and define, develop and lead regulatory strategies for assigned territories
- Prepare and review regulatory submissions
- Internal Regulatory contact for Pharmacovigilance and Marketing for Switzerland
- Provide regulatory strategies for projects as RA representative in cross-functional teams
Profile
- Degree in Science (e.g. Chemistry, Pharmacy) or equivalent
- Profound experience in pharmaceutical regulatory affairs in Switzerland, USA and Canada for sterile parenteral drugs
- Experience with Maintenance, Renewal and Extension of indications
- Previous experience in meeting with Health agencies
- Know-how regarding US and Canada regulations for DMF
- Fluent in French and English
- Good written and oral communication, technical writing and editing skills
Benefits
- Highly motivated team
- Open way of communication
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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