Associate Director/Director, Biologics CMC Regulatory Affairs

Summary

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 Associate Director/Director Biologics CMC Regulatory Affairs will play a key role in the progression of Biologics pipeline candidates by providing regulatory affairs related oversight of key CMC development and manufacturing efforts that are currently ongoing both internally and externally through a network of third-party providers including CDMOs and CROs.

The primary function of the Associate Director/Director of Biologics CMC Regulatory Affairs is leading the development and implementation of biologics CMC global regulatory strategies for FDA, USDA and other agency regulated programs in development and registration preparation for biologics animal health pipeline programs. This responsibility covers all major regions and international markets. The person selected for the role will serve as a key member with an opportunity to apply your experience and skills across all aspects of Biologics CMC Regulatory Affairs necessary to support pivotal phase clinical studies, commercial product launch and post commercial launch support. Additionally, the role will interface with CMC Development, Manufacturing, Clinical, Quality, Discovery, and external CDMO teams to maintain coherence in submission of regulatory content and compliance in quality.

Main Responsibilities

• Leads and oversees the development and preparation of Biologics CMC-related regulatory submission documents ensuring they are organized, systematic and meet current regulatory standards of FDA, EMA and/or USDA and are of high quality. The submissions include, but not limited to INAD, NADA, MAA and other regulatory agency submissions.
• Develops and implements CMC global regulatory strategies, ensuring technical accuracy and regulatory compliance while adhering to timelines and e-submission requirements.
• Collaborates closely with Dechra's other regulatory team members to devise robust global regulatory CMC strategies and risk mitigation for FDA, USDA and other agency regulated programs. Contributes to the development of comprehensive global regulatory strategic plans, to enable successful regulatory submissions and approvals.
• Engages in effective communication and collaboration with cross-functional teams, within CMC and with Clinical, to coordinate efforts and achieve regulatory compliance and operational excellence.
• Leads and/or participates in regulatory agency interactions or meetings for CMC relevant topics.
• Supports preparation of comprehensive and stage appropriate briefing books to enable regulatory agency interactions for CMC related questions and topics.
• Works with quality lead and conducts assessments of change controls and delivers regulatory evaluations of quality changes in production and quality control.
• Demonstrates proficiency in interpreting and applying regulatory guidance, provides regulatory guidance, recommendations, and solutions to cross-functional teams and key stakeholders.
• Collaborates with CMC and Regulatory teams to develop and enhance internal processes to for creating high-quality CMC regulatory documents. This includes streamlining the writing, review, and approval process, as well as critically reviewing and reconciliation of team comments.
• Supports best practice for regulatory CMC compliance activities including, but not limited to, change controls, post-marketing commitments, product complaints, and regulatory inspections. Remains current on CMC regulatory intelligence including guidelines and compendial requirements.
• Recommends changes to policies and establishes procedures that affect section or multiple disciplines.
• Represent Dechra in a consistent highly professional manner with integrity, respect, determination and in an ethical manner. Foster a team culture of collaboration, communication, ownership, and accountability.

Ideal Candidate

• 9+ years of industry experience in CMC regulatory function
• Degree in Science (Biology, Biochemistry, Chemistry, Bioengineering, etc.), BS/MS/Ph.D
• Proficiency and hands-on experience in regulatory submission and approval processes from new product development to commercialization
• Proven ability to navigate complex CMC regulatory issues and requirements effectively
• Previous regulatory experience in biologics development, especially in monoclonal antibody-based products is preferred
• Knowledge of animal health industry regulatory guidelines for CMC under FDA, EMA, USDA, and other regulatory agencies is essential
• Extensive track record in the development and maintenance of regulatory CMC documents, with a strong command of regulatory standards and requirements
• Ability to travel (domestic/international) approximately 15-20%

Desirable

• Passionate about animal health and getting innovative veterinary medicines to market
• Regulatory exposure in global regions beyond US and EU, such as Asia
• Working knowledge and understanding of current regulations and industry trends for biologics product development and manufacturing