Regulatory Affairs Scientific Leader
- 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.
- 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.
- 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