RA CMC Manager

  • Salary: Competitive
  • REF Number: 00054855
  • Consultant: Kajenthi Chelliah
  • Contact: 0041 (0) 800 106 106
  • Date Published: 13.12.2022
  • Sector:
  • Location: Basel, CH,
  • Discipline:

CK QLS are recruiting for a RA CMC Manager for a renowned Pharmaceutical company based in Basel, CH, on a contract basis for 18 months.

In this RA CMC Manager role, you will prepare & publish RA CMC documentation for submissions to Health Authorities and also, interact with HA's on RA CMC questions to support new product or post marketed launches.

The RA CMC Manager’s Responsibilities:

  • Support all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned 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 documents in accordance with project timelines.• Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders and provides high quality regulatory compliance, evaluation and strategic advice on time (change control,etc.)

Qualifications:

  • Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Working knowledge/experience in regulatory submission and approval processes desirable
  • Ability to work successfully withglobal project teams and prioritize activities considering timelines and workload.
  • Computer/IT systems literacy
  • Fluent in English

Apply: For more information or to apply for this position, please contact Kajenthi Chelliah on 0041 (0) 800 106 106 or email kchelliah@ckqls.ch Please could you send any correspondence in English. Please quote job reference 54855 in all correspondence.

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