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Regulatory Affairs Manager

vor 3 Wochen

Baar, Schweiz Universal-Job Vollzeit

In this role you are responsible for leading regional regulatory affairs activities for assigned projects and programs and for leading affiliate RA to identify and complete national regulatory requirements for assigned projects and programs, to support commercialisation. Your accountabilities will include: - Responsible for defining Biosimilar regulatory strategies for assigned projects and programs and for obtaining project team alignment on those strategies - Regulatory representative with strategic partner(s) for assigned projects and programmes and responsible for securing partner alignment on regulatory strategy - Responsible for implementing defined regulatory strategies, including filing of all appropriate regulatory submissions for assigned projects and programs

**Motivation**
Are you looking to work in a global growth company where you can make a real difference? Then you are right with us

**Firmenprofil**
Global Pharma Company.

**Spezielles**

**Erfahrung**:

- 6-years’ experience in the pharmaceutical/biotechnology industry with at least 4-years’ experience in regulatory affairs - Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements - Good knowledge of applicable regulations, regulatory guidelines and submission requirements and ability to interpret regulations and guidelines - Foster effective, positive interactions with regulatory agencies, and corporate partners

**Ausbildung**
BS degree in pharmacy, chemistry, biology, pharmacology or life sciences

**Sprachen**
English: Advanced

**Arbeitsort**
Baar

**Arbeitsbeginn**
Asap

**Vakanz-Nummer**
P-13-8124