Senior Regulatory Affairs Scientific Leader - Safety and Efficacy
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.
Dechra is 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
Dechra is an international specialist veterinary pharmaceuticals product business. Our expertise is in the development, manufacture, and sales and marketing of high-quality products exclusively for veterinarians worldwide. The primary function of this position will be to provide oversight and leadership of regulatory scientific support to products in development and during life cycle management/geo-expansion, with particular focus on safety and efficacy. Additionally, the Senior Regulatory Affairs Scientific Leader – Safety and Efficacy will be responsible to coach junior members of the US Regulatory Affairs team to develop technical regulatory skills in the field of clinical safety and efficacy.
So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:
- Lead on the development of overall regulatory strategies for products in development and in life cycle from a safety and efficacy perspective.
- Liaise within the global RA team to ensure the delivery of development plans and regulatory strategies meet the Dechra’s global business needs and timelines.
- Act as an integral member of product development teams and lead on regulatory feasibility assessments, contribute to pre-clinical and clinical study designs and establishment of regulatory timelines.
- Critically review clinical study protocols and final study reports.
- Contribute to the drafting of Safety and Efficacy Technical Sections in the US, as well as support product line extensions, remediation / maintenance activities.
- Accountable and responsible for and to lead on submission of Safety and Efficacy Technical sections of US submissions.
- Act as a source of technical regulatory safety and efficacy knowledge for development projects in NA and geo-expansions.
- Lead US Agency discussions and negotiate on the clinical program with CVM in order to de-risk projects and identify clear routes to Marketing Authorization approval.
- Mentor and develop other regulatory team members in the field of NA regulatory affairs in support of clinical safety and efficacy.
- Develop global knowledge of technical regulatory requirements for new development projects (EU and US)
- 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 of drug submissions to CVM.
- Coach and mentor Regulatory team members in clinical elements of regulatory affairs.
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 excited to hear from those who have/are:
- Expertise in product development support from a safety and efficacy regulatory perspective for New Chemical Entities and life cycle management.
- Contribute to clinical study design.
- Lead and deliver high quality Safety and Efficacy Technical Section submissions and responses to CVM.
- Lead CVM meetings (Early Information, Technical Meetings), as well as US Agency communications relating to the project.
- Ability to work cross-functionally, communicate effectively and deliver effectively on tight timelines while remaining aligned with Dechra values.
- Relationship building with key colleagues in Pharmacovigilance, Product Development, Marketing, Manufacturing, Supply Chain, Quality and Commercial to ensure information sharing and alignment on cross-functional processes.
- Accurate and timely maintenance of filing systems and documentation.
- Create a positive work environment that is aligned with company objectives and values.
- Influence and participate in relevant industry-focused working groups.
- Product animal health drug development experience
- University degree (MS, PhD, DVM) in veterinary medicine, animal sciences or relevant related life science disciplines.
About the Company
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an employee stock purchase plan for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.
Dechra Pharmaceuticals PLC