Director of Regulatory Affairs

Dechra; Boston (MA); Remote; USD 120,000 - 150,000; Full time

Job summary

A leading veterinary biotechnology company is seeking a Director to develop regulatory strategies for FDA-regulated biologicals. The role involves preparing submissions, engaging with regulatory agencies, and collaborating with cross-functional teams to ensure compliance and successful product approvals.

Qualifications

• Extensive experience in animal health pharmaceutical industry, especially in regulatory roles focused on FDA-regulated veterinary biologicals.
• Experience working with cross-functional teams.

Responsibilities

• Prepare regulatory input for development plans and protocols.
• Engage with FDA and other agencies to align development plans with regulations.
• Prepare high-quality documentation for regulatory submissions.

Skills

Communication

Interpersonal Skills

Stakeholder Relationship Building

Team Collaboration

Education

MS in a biological discipline

Job description

Summary

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 project goals and lead to regulatory approvals. They will be responsible for interactions with regulatory agencies and for preparing and submitting necessary documentation for an assigned portfolio, primarily focusing on FDA-regulated biologicals non-immunologicals (mAbs), with familiarity also required for USDA and EMA processes.

Main Responsibilities

The role involves a broad scope of duties, including:

• Preparing regulatory input for development plans, protocols, study reports, and contributing to Integrated Development Plans.
• Engaging with FDA and other agencies to ensure development plans are aligned with regulations and guidance.
• Executing regulatory filings to keep development programs on track.
• Assisting senior management in developing regulatory strategies for product approval, especially concerning FDA pathways and technical safety sections.
• Collaborating on requirements for purity and potency with CMC teams for FDA, USDA, and EMA regulated products.
• Participating in meetings with regulatory agencies.
• Working with discovery, clinical, and CMC teams to ensure smooth progression of candidates from research to approval.
• Providing regulatory input into product development.
• Keeping updated on current regulations, policies, and guidances.
• Preparing high-quality documentation for regulatory submissions, focusing on effectiveness and safety sections.
• Identifying program risks and implementing mitigation strategies.

Specific duties include:

• Filing stage-appropriate documentation.
• Responding to regulatory questions.
• Building relationships with reviewers.
• Preparing data for submissions.
• Proficiency in electronic dossier submission.
• Authoring regulatory documents.

Ideal Candidate

Dechra values diversity and inclusivity. We are particularly interested in candidates with:

• An MS in a biological discipline.
• Extensive experience in the animal health pharmaceutical industry, especially in regulatory roles focused on FDA-regulated veterinary biologicals (mAbs).
• Experience working with cross-functional teams.
• Proven success in regulatory objectives.

The following skills are essential:

• Excellent verbal and written communication.
• Strong interpersonal skills.
• Ability to build stakeholder relationships.
• Effective participation in cross-functional teams.
• Experience working remotely.