Associate Manager

vor 2 Wochen

Basel, Schweiz nemensis ag Vollzeit

Our corporate partner is an international technology and engineering group. It is a leader in its specialist field of cryogenics and thus makes an important contribution to the topic of sustainability.

Employment type: Temporary via nemensis ag, 100%

Duration: 13.02.2023 - 12.08.2024

**Salary**: CHF 47. 51./hr gross

**Responsibilities**
- As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high quality CMC regulatory documentation for our products and contribute to global regulatory submissions and strategies.
- Author high-quality global CMC documentation for regulatory submissions throughout the product lifecycle for Biologics projects/products.
- Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source docu-ments in accordance with project timelines.
- Coordinate, collect, store source documentation needed for direct submission to Health Authorities. - Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.

**Requirement profile**
- Degree in Science (e.g. Biochemistry, Biology, Biotechnology, Chemistry, Pharmacy) or equivalent. Advanced Degree in Science desirable
- Experience in regulatory and/or in the pharmaceutical industry preferred Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
- Ability to critically evaluate data from a broad range of scientific disciplines.
- Knowledge of the drug development process desirable.
- Good oral and written communication skills with a collaborative and patient-focused mindset.
- Ability to work successfully with global project teams and prioritize activities considering timelines and workload Well-developed planning, organizational, negotiation, problem solving and interpersonal skills
- Computer/IT systems literacy

**Advantages with nemensis/your future employer**

Expeditious and uncomplicated support in the field by our personnel department

Access to a large customer network and exciting positions in Northwestern Switzerland

Promotion and support of further education with temp training

**About us**

At nemensis ag, we have connected thousands of applicants to their dream job and given them the opportunity to develop or re-enter the job market. What can we do for you and your career today? Get in touch with us

For further questions please contact:

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