Senior Principal Scientist – Biotherapeutic Product Innovation, Global CMC Regulatory Affairs

Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra

We 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 almost 3000 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 Senior Principal Scientist – Biotherapeutic Product Innovation, Global CMC Regulatory Affairs is a senior regulatory leader responsible for defining and executing global CMC regulatory strategies for complex biotherapeutic products. The role plays a critical part in advancing biopharmaceutical pipeline candidates by providing strategic regulatory oversight of key CMC development and manufacturing activities conducted both internally and through a network of external partners, including CDMOs and CROs. 

This position provides leadership across CMC development, manufacturing, and regulatory activities to support efficient progression from early development through commercialization and lifecycle management. 

The incumbent will leverage deep experience with monoclonal antibody and related biologic products to shape development strategies, anticipate regulatory expectations, and lead interactions with global health authorities, including FDA, EMA, and other major agencies. 

As a senior leader the roles serves as a key cross-functional partner across CMC Development, Manufacturing, Quality, Clinical, and Discovery, as well as external CDMO and CRO partners, to ensure alignment of regulatory strategies, consistent and high-quality submissions, and compliance with evolving global requirements.  

The person selected for the role will apply their experience and skills across all aspects of CMC Regulatory Affairs to support pivotal phase clinical studies, commercial product launches and post-approval lifecycle activities.  

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:

• Leads and oversees the development and preparation of biopharmaceutical CMC-related regulatory submission documents ensuring they are organized, systematic and meet current regulatory standards of FDA, EMA,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,EMA 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.
• Represent Dechra on trade associations, working groups, and consortia focused on CMC and biotherapeutic regulation. 
• Contribute to industry position papers to help shape evolving regulatory frameworks.
• Monitor emerging regulatory trends and actively influence policy and guidance impacting CMC requirements for biotherapeutics. 
• 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

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:

• Degree in Science (Biology, Biochemistry, Chemistry, Bioengineering, etc.), BS/MS/Ph.D with 9+ years of industry experience in CMC regulatory function.
• Significant experience in biologics development, with strong emphasis on monoclonal antibodies, is required. 
• Demonstrated experience in regulatory strategy development and direct engagement with regulatory agencies.
• Deep expertise in CMC regulatory requirements for biotherapeutics, including development, manufacturing, control strategy, and lifecycle management.  
• Proven ability to interpret complex regulatory expectations and translate them into effective CMC development plans and manufacturing strategies. 
• Strong knowledge of animal health regulatory guidelines for CMC under FDA, EMA and other global regulatory authorities.
• Extensive experience in the development, review, and maintenance of high-quality regulatory CMC documents, demonstrating a strong command of regulatory standards and requirements. 
• Experience contributing to or representing organizations in industry groups or trade associations externally to Dechra and strategically influencing the geographical input, strongly preferred. 
• Ability to travel (domestic/international) approximately 15-20%. 

All applications received are reviewed by our internal talent acquisition team and we will get in touch if your skills and experience match what we’re looking for. Should you not hear back from us within 28 days please don’t be too disappointed – we may keep your CV on our database for any future vacancies which may be suitable and we encourage you to keep an eye on our careers site. 

For any questions or queries, please contact us at recruituk@dechra.com