To complete regulatory and technical work as required, covering human and veterinary medicines, medical devices, biocides, cosmetics, general products and supplements.
Key Objectives:
* To complete regulatory and technical work as required covering human and veterinary medicines, medical devices, biocides, cosmetics, general products and supplements.
* Communicating with the regulatory authorities and notified bodies.
* Contribute to the Regulatory team process improvements.
* Independent preparation of regulatory submissions for medicinal products, which may include, but are not limited to, new license applications, variations, responses to questions and renewals.
* Coordinate and review technical documentation.
* Involvement with medical device regulatory work.
* Writing sections of Module 3 of dossiers and Quality Overall Summaries.
* Providing technical support in the context of the regulatory framework.
* Participate in regulatory team meetings and manage assigned tasks/projects and provide regular updates.
* Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.
* Perform administrative activities within the function.
* Any other duties reasonably associated with this position as assigned by the Board of Directors.
Experience, Background, and Knowledge:
* Minimum of 3 years experience working in a pharmaceutical regulatory based role.
* Ability to work in a team.
* Good with detail and proofreading.
Qualifications, Professional Memberships, and Licences:
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