Regulatory Affairs Manager 100%

Vor 7 Tagen

Basel, Schweiz nemensis ag Vollzeit

For our client, an international pharmaceutical company in Zurich, we are in search for a **Senior Regulatory CMC Manager (f/m/d).**

**Responsibilities**:

- Prepare CMC responses to health authority questions during development, registration and product lifecycle
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
- Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
- Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned
- Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions)
- Establish and maintain sound working relationships with partners and customers

**Qualifications**:

- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Regulatory experience, and/or experience in drug/biopharmaceuticals
- Knowledge of the drug development process desirable
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
- Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance
- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
- Fluent English skills (oral and written), good German skills (oral)

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