The Opportunity
Dechra is an international specialist veterinary pharmaceuticals products business. The primary purpose of the Employee will be to lead a team that will prepare, submit, maintain and expand the specified product registrations in specified countries and to assist in the registration of new veterinary medicinal products (and other Dechra products when needed) in specified International markets. Additionally, the Employee will be responsible for ensuring that all products and activities carried out by their team are in compliance with all regulatory needs and for cross‐functional liaison with other RA groups internally and with other Dechra Departments including the ANZ affiliate to promote alignment, innovation and development of more efficient processes.
Main Responsibilities
* Managing the sub‐team to ensure that all tasks, needs and KPIs are met.
* Managing the sub‐team with regards to human resource management and development.
* Compiling, reviewing and submitting new Marketing Authorisation applications in international territories.
* Organising submission of Marketing Authorisation variations and renewal/re‐registration applications (where relevant) for international markets.
* Coordinating with National Competent Authorities (NCA) and relevant colleagues/partners during an application evaluation process to prepare and submit timely responses to authorities' comments and questions.
* Liaising with Labelling/Artwork Coordinators where needed to coordinate new artwork production for product packaging according to regulatory legislation and Dechra packaging guidelines following approval.
* Preparing and regularly checking Quality Product Compliance Summaries for pharmaceutical products.
* Constantly monitoring changes in legislation/guidelines to ensure all submissions are up to date with the latest requirements.
* Archiving of registration documentation.
Ideal Candidate
* Advanced/Professional university or bachelor degree in chemistry, chemical engineering, medicine, pharmaceutics, biochemistry, or related disciplines.
* The ability to travel internationally (infrequently).
* Fluency in written and oral English.
* Strong communication and presentation skills.
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