Regulatory Affairs Senior Manager - ANZ

Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra!

Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 3000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.

The Opportunity

Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales and marketing of high-quality products exclusively for veterinarians worldwide. 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. Furthermore, the Employee will also be responsible for ensuring that all products and activities carried out by their team are in compliance with all regulatory needs. The Employee will also be responsible for cross-functional liaison with other RA groups internally in RA INT but also outside RA INT and also other Dechra Departments including the ANZ affiliate in order to ensure and promote alignment, innovation and development of more efficient processes.

Main Responsibilities

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

Managing the sub-team to ensure that all below needs, tasks and KPI’s 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.
To organize submission of Marketing Authorisation variations and renewal/re-registration applications (where relevant) for International markets.
To coordinate 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.
To liaise with Labelling/ Artwork Coordinators where needed to co-ordinate new artwork production for product packaging according to regulatory legislation and Dechra packaging guidelines following approval.
Prepare and regular check Quality Product Compliance Summaries for pharmaceutical products.
To constantly monitor changes in legislation/guidelines to ensure all submissions are submitted to the latest requirements.
Archiving of registration documentation.

Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are:

Advanced/ Professional University or Bachelor degree in chemistry, chemical engineering, medicine, pharmaceutics biochemistry, or related disciplines
Significant Regulatory Affairs experience
The ability to travel Internationally (infrequently).
Fluency in written and oral English
Proficient computer skills
Communication and presentation skills
Problem solving skills
Knowledge sharing skills

All applications received are reviewed by our internal talent acquisition team and we will get in touch if your skills and experience match what we’re looking for. Should you not hear back from us within 28 days please don’t be too disappointed – we may keep your CV on our database for any future vacancies which may be suitable and we encourage you to keep an eye on our careers site. For any questions or queries, please contact us at recruituk@dechra.com

recruituk@dechra.com

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