Regulatory Affairs Associate CMC Manager

Basel, Switzerland

Posted:15 days ago
Location:Basel, Switzerland
Job Ref:BH-34786
Job Type:Contract
Salary:CHF40 - CHF44 per hour
Expiry date:2/2/2023
Contact:Audwin Cheung
Xplore Life Sciences are recruiting for an Associate Regulatory Affairs CMC Manager to work for a Global Leader in Pharmaceuticals based in Basel. 

This is an 18 Month freelance contract and you must have valid right to work in Switzerland and be able to commute to site in Basel.

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.
Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities.In addition interact with HA's on REG CMC questions to support new product or post marketed launches.
Key Duties:

  • Author high-quality global CMC documentation for regulatory submissions throughout the product lifecycle for Biologics projects/products. 
  • Apply agreed CMC global regulatory strategies, current regulatory trends and guide-lines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. 
  • Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents 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
Key Attributes:
  • 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
  • English is a must have and German highly desirable
Desirable Requirements
  • Degree in Science (e.g. Biochemistry, Biology, Biotechnology, Chemistry, Pharmacy) or equivalent. Advanced Degree in Science preferred
  • 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.

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