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Senior Regulatory Affairs Manager
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 markets. * 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.
Leading biopharmaceutical company
Senior Regulatory Affairs Manager excellent opportunity
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 assets
Our client is a leading biopharmaceutical company.
An excellent opportunity to join the Regulatory Team as a Senior Regulatory Affairs Manager in a leading biopharmaceutical company.