Role details

Senior Regulatory Affairs Manager

Vaud   •  Permanent

Bullet points

  • Leading biopharmaceutical company
  • Senior Regulatory Affairs Manager excellent opportunity

About Our Client

Our client is a leading biopharmaceutical company.

Job Description

Advising and conducting the Regulatory Affairs strategy of in close coordination with CROs involved.
* To gather all data and documents required to prepare and file
Regulatory Submissions with the FDA, EMEA and SwissMedic
* To keep management permanently informed of regulation covering
approval of the company's products and their maintenance in various
* To ensure that Regulatory constraints are met during
the pre- and clinical investigations and after market approvals.
* To represent our client to the regulatory bodies.
* To ensure our client remains permanently in compliance with
regulatory legislation.
* Supports the business development team on technical due diligence
associated with in-licensing, acquisitions, and co-development
agreements regarding regulatory aspects.

The Successful Applicant

The candidate should have the following qualifications:
* Degree in Pharmacy; Biology or Life Sciences
* At least 5 years of successful experience in Regulatory Affairs in
Pharmaceutical Industry
* Specific experience should cover:
* requesting and obtaining scientific advice from regulatory bodies.
* filing and obtaining approval of CTAs; IND/IMPD; successful
submission of Phase I to III clinical files.
* filing and obtaining approval of MAA.
* experience in controlling and integrating manufacturing; QA and
QC regarding regulatory submission would be an asset.
* Personal features include:
* excellent interpersonal and communication skills
* ability to build effective working relationships within the company
and with regulatory agencies
* team player
* fluency in English is a must; French and a third language are

What's on Offer

An excellent opportunity to join the Regulatory Team as a Senior Regulatory Affairs Manager in a leading biopharmaceutical company.

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