Regulatory Affairs Scientific Leader
Please Note: The application deadline for this job has now passed.
Job Introduction
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals Limited. 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 over 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 Regulatory Affairs Scientific Leader - CH has responsibilities for preparation, submission and maintenance of the specified product registrations in Switzerland.
- To provide technical regulatory expertise to support Dechra activities in Switzerland.
Main Responsibilities
- Design of registration operating plans to ensure senior management objectives are achieved.
- Liaison with manufacturers and /or EU/UK RA teams, 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 initial submissions. Project manage the procedure from initial preparation to approval.
- Regulatory risk assessments with strategic guidance from senior team members
- Leading technical RA Agency meetings.
- Prepare and maintain product summaries and labelling for pharmaceutical, nutritional and care products.
- Assessment of change control projects to evaluate impact for CH registrations.
- Track status of regulatory activities and update respective databases on time.
- Self-initiative to study updates in Swissmedic regulations and requirements.
Ideal Candidate
- University or bachelor’s degree in chemistry, veterinary medicine, chemical engineering, medicine, pharmaceutics biochemistry, or related disciplines
- Must be able to speak fluent German and English
- Previous RA experience within Animal Health
- Fluency in written and oral English
- Proficient computer skills
- Communication and presentation skills
Dechra Pharmaceuticals PLC