Drug Regulatory Affairs - Senior Manager (Start from 1st of July 2019)

BaselPermanentChemistry, Pharma, Biotech2019-05-16Not Required / Untrained
For a pharmaceutical company in Switzerland (Basel area) we are actively looking for an experienced Senior Manager in Drug Development (English speaking) starting 1st of July 2019.

Drug Regulatory Affairs - Senior Manager (Start from 1st of July 2019)

Your challenges

•You are responsible for leading some global regulatory activities, including operational and strategic activities in drug development, registration and post-marketing phases.
•You are reporting to the Head of Drug Regulatory Affairs
•You are collaborating closely with Clinical Operations, Clinical Sciences, Pharmacovigilance, Biostatistics, Preclinical or CMC within the Headquarter based in Switzerland
•You are responsible for provision of regulatory input into global development plan for a Phase II compound
•You will bes responsible for Clinical Trial Authorisation applications and maintenance
•You will review of Regulatory documents
|You will manage Document Management as electronical filing and archiving the documents according to SOPs

Your skills

•You bring mandatory previous experience in a pharmaceutical company or a CRO
•You bring a minimum of 5 years of experience in a similar role in Regulatory Affairs
•You bring a minimum of a Bachelor degree in Life Sciences
•You bring experience in Clinical Trial Applications
•You bring knowledge of EU/US clinical trials guidelines & regulations
•You bring experience in operating within complex matrix organization

Your horizons

Our client offers an attractive package with a competitive salary combined with opportunities for personal development and growth.

Applicants must have the authorization to work within the hiring country (Switzerland) and be ready to start 1st of July 2019.

Your contact

Lisa Bianculli, Recruitment Consultant, looks forward to answer your questions by phone +41 58 233 2102.

You can apply directly online.