Drug Regulatory Affairs Manager

The Job

In this challenging position you will assume responsibility for the regulatory life-cycle management of our product range with focus on CMC activities

The major tasks included in this role are

• To lead in interdisciplinary change management team and evaluate the regulatory relevance of proposed CMC-changes
• To ensure availability of and/or prepare technical regulatory documents for obtaining rapid and advantageous approvals of CMC variations
• To negotiate, advise and obtain quality data and documentation from third parties for in-sourced substances
• To critically review source information and identify quality or timeliness issues as early as possible
• To manage the dossier preparation, submission and approval of CMC variations and license renewals in the European Union
• To serve as regulatory interface to third party clients
• To actively participate in the implementation of an electronic Document Management System and a registration status tracking database

Your Profile

• The minimum educational requirements for this demanding position are a Masters Degree in Pharmacy, Chemistry, Biology or another life science. Furthermore several years of industry experience in international regulatory affairs is key - preferably in the CMC life cycle management area - as well as excellent knowledge of the European drug regulations, guidelines and the submission and approval procedures.
• Additionally you have good negotiation and analytical skills which enables you to deal with complex CMC regulatory issues. You also have very good communication and interpersonal skills as well as the ability to easily read, write and negotiate in English and German. Computer-literacy (MS-office tools) is a must, good understanding of databases and document management an asset.
• You are target-oriented and able to work under pressure and on multiple tasks simultaneously as well as to influence others in a matrix organisation.

Location

1) Miesbach (close to Munich, Germany) or 2) Basel (Switzerland)

To apply please send your CV and references to Cecilia Meijer on cecilia.meijer@theRSAgroup.com. The consultant leading this assignment is Junior Kimper who can be contacted on +41 (0) 41 766 7266 and Oliver Schiltz who can be contacted on +41(0)41 7667263. If you would like to have a confidential discussion you might want to contact Cecilia +41 (0) 417667267.

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