Regulatory Affairs Scientific Leader - Safety and Efficacy
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 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 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 primary function of this position will be to provide oversight and leadership of regulatory scientific strategy to products in development and during life cycle management with particular focus on safety and efficacy. Additionally, the Regulatory Affairs Scientific Leader will be responsible for mentoring junior members of the US Regulatory Affairs team to develop technical regulatory skills in the field of clinical safety and efficacy.
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:
- To lead the development of overall regulatory strategies for products in development (both INADs and JINADs) and the life cycle management phase from a safety and efficacy perspective
- To liaise within the global RA team to ensure the delivery of development plans and regulatory strategies meet Dechra’s global business needs and timelines
- To act as an integral member of product development teams and lead regulatory feasibility assessments, contribute to pre-clinical and clinical study designs and establish regulatory timelines
- To contribute to and critically review clinical study protocols and final study reports
- To lead and be accountable for drafting US Safety and Efficacy Technical Sections, meeting materials and other US regulatory submissions, as well as support product line extensions, remediation / maintenance activities relating to safety and efficacy
- To be a source of technical and scientific regulatory knowledge for development projects in NA
- To develop and maintain positive working relationships with individuals at the US regulatory agency level, lead US Agency discussions, and negotiate the clinical program to de-risk projects and identify clear routes to Marketing Authorization
- To mentor junior regulatory team members in the field of US regulatory affairs in support of their clinical safety and efficacy knowledge
- Design of registration strategies 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
- Liaise with Product Development and external experts to develop the Safety and Efficacy Technical Sections in support of US drug approval
- Act as a source of knowledge in clinical elements of regulatory affairs for the US Regulatory team
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:
- A minimum of 5 years’ experience in animal health pharmaceutical regulatory affairs including supporting product development, with some of that experience focused on safety and efficacy. A minor portion of this total 5-year period may have been spent gaining other relevant experience in the animal health sector.
- University degree (MS, PhD, DVM) in veterinary medicine, animal sciences or relevant related life science disciplines.
- Animal health drug development experience
- Fluency in written and oral English
- Excellent communication and presentation skills
- High analytical acumen
Dechra Pharmaceuticals PLC