For our customer, a global pharmaceutical leader based in Zürich, we are looking for a
Regulatory Affairs Manager - Gastrointestinal therapeutics
- Leads the regulatory working team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan
- Collaborates to define, develop and lead strategies to maximize regulatory success towards achievement of program objectives and ensures own critical deliverables as agreed within the global regulatory strategy and planning
- Manages, plans and executes the preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned program
- Provides regulatory expertise and strategic focus for assigned development projects and/or marketed product life cycle management to global regulatory team
Effectively communicates with stakeholders on objective assessments of the likelihood of success of these regulatory strategies
- Scientif degree
- min of 4 years experience in Regulatory Affairs
- working experience in the pharmaceutical industry and of regulations and guidance governing drugs and
biologics in development, including post-marketing in EU and including interactions with Health Authorities
- experience in managing relationships with CROs and contractors is preferred
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Simone Mumbauer, PhD (+41 44 225 41 12).
We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers.