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.
This company is a part of a global brand developing and manufacturing medical devices, pharmaceuticals and over the counter products.
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
- 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
For more information or to apply for this Regulatory Consultant position, please contact Jocelyn on 0041 (0) 782 516 595 or email firstname.lastname@example.org, quoting job ref 47920
It is essential that applicants hold entitlement to work in the UK.