Junior Regulatory Affairs Manager

vor 7 Monaten

Zurich, Schweiz Bayer Vollzeit

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Junior Regulatory Affairs Manager (M/F/d)**

**YOUR TASKS & RESPONSIBILITIES**
- Full regulatory management of assigned portfolio under supervision of Head Regulatory Affairs (RA) Consumer Health (CH) Switzerland, including marketability assessment, marketing authorization and life cycle management
- Draft, Change Management and Implementation of SmPC, PIL and all product relevant artworks acc. to local and global regulations
- Management of all Regulatory databases (DORIS, SYNAPS, etc.) that hold information regarding production, quality and statutory texts in the marketingapprovals, which are key to compliance
- System Administrator for external electronic systems (e.g. Portal, HCI) and responsibility for training RA team
- Management and response of Health Authority requests on assigned portfolio under the supervision of Head RA CH Switzerland within given timelines
- Support Head RA CH Switzerland on development and maintenance of new standard operating procedures relevant for local team
- Regulatory support of internal functions like marketing, communication, legal, on external and internal requests on assigned portfolio
- Ensure compliance with all relevant codes of practice

**WHO YOU ARE**
- Scientific university degree preferred (natural sciences or pharmacy)
- Minimum 12 months experience within Regulatory Affairs, preferably within Switzerland
- Knowledge of local regulatory-relevant legislation
- Good knowledge of IT in order to work with databases and to prepare high qualitydocuments
- Ability to work in a team
- Ability to analyze, organize and plan effectively with good communication skills
- Independent and solution-driven working style
- Commercial awareness and good information management skills
- German (fluent); good knowledge in English (written & spoken), knowledge in French & Italian is a plus

**YOUR APPLICATION**

**Location**:
Switzerland : Zürich : Zurich

**Division**:
Consumer Health

**Reference Code**:
817405

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