Job Description
Director of Regulatory Affairs Job Introduction *This is a remote position open to candidates located in the US 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 FDA regulated biologicals non-immunologicals (monoclonal antibodies, mAbs) but the Director will also have familiarity with USDA and EMA regulatory processes.
Role Responsibility So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:
- 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 FDA and other agencies to ensure development plans are robust, aligned with regulation, agency expectations and guidance's
- 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 FDA and other agency regulatory pathways, 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 FDA (and USDA and EMA) regulated products.
- Organize and participate in meetings and other interactions with FDA 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 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
- Ensure proficiency in electronic dossier submission
- Authorship of regulatory documents
- Ensure proficiency in electronic dossier submission
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:
- MS in a biological discipline
- Extensive experience within the Animal Health pharmaceutical industry, within a regulatory position, preferably focused on the FDA regulated veterinary biological non-immunologial medicinal products (mAbs) regulatory pathway.
- Significant experience participating in cross-functional teams.
- Experience collaborating with regulatory agencies and other partners.
- Proven success in achieving objectives comparable to those of this position.
- Expected travel 20-25% (domestic and international)
A high level of proficiency in the following areas is required:
- 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
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.
Job Tags
Full time, Work at office, Remote work, Flexible hours,