QA And Regulatory Consultant
CK QLS are recruiting for a Regulatory Consultant to join an international biopharmaceutical company at their site based at their site just outside of Basel on a contract basis until the end of July 2020, with the possibility of extension.
Company:
This company is a part of a global brand developing and manufacturing medical devices, pharmaceuticals and over the counter products.
Location:
This Regulatory Consultant role will be based at our clients site just outside of Basel.Regulatory Consultant responsibilities include:
- Providing strategic and tactical input in development, post-approval and Life cycle management
- Driving an understanding of central and national regulatory requirements
- Developing and ensuring effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan
- Establishing and maintaining strong relationships with Regulatory Agencies, and acting as point of contact with EMEA, an deffectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments
- Advising team on required documents and processes to support Regulatory Agency contacts and submission
Your Background:
- University degree is desired, within medical, pharmacy, biology, veterinary etc. or equivalent.
- Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
- Experience with EU regulatory procedures (CP, MRP, national)
- Experience in working in project teams and/or a matrix organization
Apply:
For more information or to apply for this Regulatory Consultant position, please contact Jocelyn on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 47920
It is essential that applicants hold entitlement to work in the UK.
