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Senior RA Scientific Leader

Job Introduction

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

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 2000 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 

  • The Senior Regulatory Affairs Scientific Leader has responsibilities for preparation, submission, maintenance and expansion of the specified product registrations in specified countries.
  • To support product development project teams and negotiate on the CMC/safety/clinical program with the regulatory agencies in order to identify clear routes to Marketing Authorisation approval.

Role Responsibility

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

  •  Design of registration operating plans to ensure senior management objectives are achieved.
  • Provide regulatory guidance to the product development teams to ensure any proposed studies are prepared to meet guidelines and support product registrations.
  • Liaison with manufacturers to prepare Part II (Chemistry and Manufacturing) of new drug submissions for Veterinary Medicinal Products.
  • Prepare and submit variation applications for existing products to ensure existing dossiers reflect current practice • Prepare CH regulatory submissions. Project manage the procedure from initial preparation to approval
  • Project based regulatory risk assessments with strategic guidance from senior team members.
  • Leading technical RA Agency meetings.
  • Prepare and maintain product summaries for pharmaceutical products.

The 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:

  • Ability to demonstrate a methodical, organised and flexible approach to work.
  • Effective listening, verbal and written communication skills
  • Excellent interpersonal skills, with the ability to communicate effectively with all levels, establishing and maintaining effective working relationships
  • Ability to plan, organise and prioritise workload to meet deadlines Professional approach Ability to maintain a high level of confidentiality and discretion at all times
  • University or Bachelor degree in chemistry, veterinary medicine, chemical engineering, medicine, pharmaceutics biochemistry, or related disciplines
  • At least 10 years regulatory affairs experience

About the Company

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

Apply

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