Regulatory Affairs Associate (m/f)

Job description

Job Description

Main responsibilities:
- preparation of Module 1 documents in accordance with defined regulatory strategy
- ordering and collection of relevant documents together with relevant stakeholders, as per defined regulatory strategy
- technical compilation of dossier for new product submission and on-time dispatch of complete package for new product submission to country organization, in line with annual submission plan
- technical compilation of dossier for response to questions from Health Authorities in collaboration with RCC manager
- technical compilation of variation package and on-time dispatch of complete package to country organization, as per defined timelines
- regulatory compliance in the respecting cluster – following Good Regulatory Practice and internal Sandoz quality standards
- full compliance of internal regulatory tools and systems
- other administrative tasks supporting RCC CEEMEA as defined by RCC manager or Head of department.

Desired profile

Minimum requirements

Requirements:
- bachelor’s degree in Chemistry, Biochemistry, Pharmacology, Pharmacy or other relevant disciplines,
- fluent in English,
- excellent MS Office skills,
- organizational and time management skills,
- team oriented, resilient, precise working style, willingness for further development,
- good knowledge of dossier CTD format is an advantage.

We offer permanent employement with 6 months of probation period.

You are kindly invited to submit your application, including CV by February 18th, 2018 on our website https://www.sandoz.com/careers/career-search#division=Sandoz