Director/Senior Director Regulatory Affairs
Job Introduction
This is a US remote role, with a preference for candidates based in the Boston area.
Invetx, a division of Dechra, is a veterinary biotechnology company focused on developing protein-based therapeutics for chronic conditions in companion animals, with an emphasis on monoclonal antibodies (mAbs). Our proprietary innovation platform integrates leading industry technologies to create species-specific, half-life extended mAbs that are longer-lasting, safe, effective, and more affordable than current treatments. As part of Dechra, a global leader in veterinary pharmaceuticals, Invetx supports Dechra’s mission to sustainably improve global animal health and welfare.
The Director will develop and execute successful regulatory strategies to achieve agreed project goals, ultimately leading to regulatory approvals. The Director is directly responsible for the day-to-day interactions with regulatory agencies and for the preparation and submission to agencies of the required components of an assigned portfolio of development programs. The particular emphasis of this role will be directed to USDA-regulated biologics (noting that Invetx’s portfolio comprises mAbs rather than traditional vaccines) but the Director will also support the progression of assigned projects through EMA and have familiarity with FDA regulatory processes.
Role Responsibility
- Prepare regulatory input to development plans, pilot and pivotal protocols and study reports and contribute to the preparation of Integrated Development Plans.
- Engage regularly and effectively with USDA and other agencies to ensure development plans are robust, aligned with regulation, agency expectations and guidances
- Execute regulatory filings to ensure development programs remain on track through pre-clinical, pilot and pivotal programs.
- Assist the Chief Development Officer to develop appropriate regulatory strategies leading to approval of Invetx’s product candidates, particularly those aspects related to the USDA regulatory pathway, and the effectiveness and target animal safety technical sections.
- Assist the Chief Technology Officer and the Director Regulatory CMC in the requirements for the purity and potency aspects for USDA-regulated products.
- Organize and participate in meetings and other interactions with USDA APHIS-CVB and other relevant regulatory agencies.
- Collaborate with Discovery, Clinical and CMC personnel to ensure seamless and efficient progression of early-stage candidates from research to proof of concept to clinical development and ultimately, to approval.
- Provide authoritative regulatory input into product development plans.
- Maintain up-to-date knowledge of current regulations, policies and guidances of regulatory agencies (especially USDA) and associated bodies.
- In collaboration with other functions, prepare high-quality documentation for regulatory submissions (especially pertaining to the effectiveness and target animal safety technical sections of dossiers), for timely filing with the appropriate agencies.
- Identify program risks and create and implement mitigation strategies.
- Specific regulatory duties include:
- File stage-appropriate regulatory documentation
- Provide responses to regulatory questions
- Build and maintain effective relationships with regulatory reviewers
- Prepare study data for submission to regulatory agencies
- Authorship of regulatory documents
- Ensure proficiency in electronic dossier submission
The Ideal Candidate
- 5+ years of experience within the Animal Health pharmaceutical industry, with 2+ years in a regulatory position, preferably focused on the USDA regulatory pathway.
- 5+ years of experience participating in cross-functional teams.
- MS in a biological discipline
- Experience collaborating with regulatory agencies and other partners.
- Proven success in achieving objectives comparable to those of this position.
A high level of proficiency in the following areas is required:
- Knowledge of the regulatory requirements for approval of USDA-regulated veterinary biologicals
- Verbal and written communication
- Interpersonal interactions
- Building strong relationships with relevant stakeholders
- Participating and performing effectively within cross-functional teams
- Working in a remote-office environment and in a virtual project team environment
- Microsoft Office software
- Planning, managing, and delivering programs leading to regulatory approvals
Desirable
- Experience in mAb veterinary biologics particularly those regulated by the USDA Center for Veterinary Biologics in the USA.
- PhD, preferably in a biotechnology or animal health discipline
- Doctor of Veterinary Medicine (DVM) or equivalent
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 other incentives 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.