Regulatory Affairs Executive – VAF 190

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: