Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research. With a hugely experienced and successful executive management team this company has a newly created vacancy for an experienced Regulatory Affairs Director.This newly created senior management position will be located in Dublin.
The Regulatory Affairs Director will be responsible for the comprehensive management of regulatory aspects of the company’s European development projects while actively contributing as a member of the regulatory project team and company project team(s). This position will also require key contributions to department and company initiatives related to regulatory affairs operations and strategy with a focus on Europe.
Duties and Responsibilities
- Responsible for working with the project team to identify an optimum European regulatory strategy for assigned projects. Able to lead teams in examining regulatory strategy options.
- Expected to independently interact with regulatory authorities, and outside consultants when needed. Able to independently prepare and lead a team through a European Health Authority regulatory meeting.
- Able to write, review and edit regulatory documentation, insuring it is fit for purpose, and to serve as a resource for regulatory document authors regarding the appropriate content of submissions.
- Minimum Bachelor’s degree; studies in science and advanced degree desirable
- Minimum 10+ years progressive Regulatory Affairs or relevant experience
- Specialized knowledge that would be desirable and supportive of success in this position includes:
- Understanding of regulatory requirements for and experience with submission of applications (CTA/MAA) in eCTD format
- Ability to create and manage detailed timelines and/or experience with tracking regulatory activities across disciplines and territories
- Experience in other key functional areas, (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics) appreciated
- Experience with US and international management of post-marketing CMC changes
- Experience in paediatric drug development and understanding of EU regulations related to paediatric requirements
- Experience in the management of core labeling and/or EU labeling
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