Senior Regulatory Affairs Manager
|Job Title:||Senior Regulatory Affairs Manager|
|Salary:||Very well paid.|
|Contact Name:||Charles Leach|
|Job Published:||October 09, 2018 17:48|
My client, a global biotechnology company is currently seeking the expertise of a Senior Regulatory Affairs Manager in order to further their New Drug Applications, Full Life Cycle Maintenance, Regulatory Strategy and Dossier Submission for their exciting pipeline of drug products.
Senior Regulatory Affairs Manager Key Responsibilities:
- Develop and implement regulatory strategy for assigned markets (ROW)
- Manage the process for the successful preparation, submission and timely approval of marketing applications, labelling and general product life cycle maintenance
- Manage client interactions as well as internal and external stakeholders
- Review scientific documentation and supporting country specific documents for submission to global regulatory bodies
- Assess of the impact of new regulations and guidance documents and makes process improvement recommendations to group
Senior Regulatory Affairs Manager Key Requirements:
- Strong experience of Regulatory Affairs in RoW markets (10+ years) following a degree in a Life Science subject
- Experience in preparation and/or submission of documentation for ROW agencies: such as CMPs/CPPs, MAAs, variations PSURs including country specific requirements (declarations, LoA etc…)
- Display sound project and line management skills, being a positive influencer in those who work around them
- Communicates effectively in verbal presentations and in writing strategy plans
- Knowledgeable and experienced in interpretation of regulations and guidelines related to drug development
If successful, you can expect a highly competitive salary package with fantastic benefits and the opportunity to work on an exciting pipeline of various drug products.
Please call Charles on 01619427163 for more information on rates and applying.
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