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Head of Regulatory Affairs - Global 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 purpose of this position is to effectively recruit and lead a team of dedicated RA scientists with expertise in clinical safety and efficacy across the global portfolio to deliver Dechra’s goals, and to enhance technical regulatory collaboration with the R&D and manufacturing teams.

The scope of this position includes novel pharmaceutical and biotechnological development projects, generic development projects, and also major variations/updates where new safety or efficacy data are required or technical challenges exist for the maintenance of Dechra’s existing portfolio at the global level. This position will help grow and perpetuate a culture of positive collaboration, coaching and mentoring across the RA safety and efficacy teams, and drive RA process improvement and increase RA safety and efficacy expertise within the whole RA team.

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:

  • Provide analysis of required resources to cover defined areas of responsibility and lead recruitment of new RA safety and efficacy team members to form an effective, high performing team
  • Responsible for the planning and monitoring of the achievement of the RA safety and efficacy team for the areas of activity to drive quality and efficiency of submissions
  • Manage all Regulatory safety and efficacy product registration strategies, activities and resources for defined areas of activity with focus on US, UK, and EU 
  • Manage the RA Budget for areas of activity
  • Participation in activities of other departments in jobs related to the scope of work of RA safety and efficacy
  • Oversee and coordinate the preparation of the documentation needed for initial submissions, variations and/or renewal
  • Preparation of the appropriate safety and efficacy areas of the registration dossier, in accordance with the legislation of the target markets
  • Distribution and storage of relevant safety and efficacy registration documentation
  • Active monitoring of legislation and regulatory situation on target markets in safety and efficacy related RA areas
  • Due diligence for acquisitions and Business development opportunities in the safety and efficacy space 
  • Writing / reviewing safety and efficacy expert reports 
  • Promoting organizational values and organizational culture through one's own behavior and encouraging others' desired behaviors.

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:

  • At least 8 years animal health regulatory affairs experience of which at least 5 years should be safety and efficacy focused
  • Fluency in written and oral English
  • Prior leadership experience required
  • Proficient computer skills
  • Coaching, communication, and presentation skills
  • Leadership skills (motivation, communication, leadership, processes, and changes management) 
  • Strategic thinking and creative problem solving
  • University degree and/or tertiary degree in veterinary medicine, pharmacy, biochemistry, or related life science disciplines

Dechra Pharmaceuticals PLC

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