About the role
Welcome to Dechra
Dechra is an international veterinary pharmaceutical business focused on specialty products. We develop, manufacture, sell and market high-quality products exclusively for veterinarians around the world.
Job Purpose
The Director – US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs is responsible for leading the CMC Regulatory Affairs team with a focus on approved product, CMC compliance, lifecycle management, and post-approval regulatory strategy for FDA and internationally approved veterinary pharmaceuticals.
This role provides regulatory leadership in support of Dechra Manufacturing and Supply (DMS), including regulatory oversight of technology transfers, site strategy, manufacturing changes, product and process improvements, and alignment with long-term supply chain and manufacturing optimization initiatives.
In addition to providing support of US and internationally approved products, the Director will also lead global CMC innovation for small-molecule products, guiding the RA CMC team in the development and implementation of CMC global regulatory strategies for FDA, EMA and other agency regulated programs in innovation and registration preparation for animal health pipeline programs. This responsibility covers all major regions and international markets.
The person selected for the role will serve as a key leader within the global RA CMC team with an opportunity to apply their experience and skills across all aspects of CMC Regulatory Affairs necessary to support initial marketing authorization strategies, commercial product launch, and post-approval CMC initiatives. Additionally, the role will interface with the RA CMC Leadership team, DRD CMC Development, Manufacturing, Clinical, Quality, Discovery, and external CDMO teams to ensure the appropriate execution of the regulatory strategy and quality compliance.
KEY RESPONSIBILITIES
Lead the US Regulatory Affairs CMC team, setting priorities and supporting the team’s delivery of high-quality regulatory strategies and submissions.
Provide strategic US CMC regulatory leadership across development and lifecycle activities, ensuring regulatory requirements are considered throughout product planning.
Oversee the preparation, review and submission of CMC sections for US regulatory applications, amendments, supplements and responses to health authority questions.
Partner with Global CMC Regulatory Affairs colleagues and cross-functional teams, including technical development, manufacturing, quality and supply, to align regulatory plans and business objectives.
Advise project teams on US regulatory requirements, risks and opportunities, and recommend practical approaches to address complex CMC issues.
Build and advance innovation in CMC regulatory processes, tools and ways of working to improve effectiveness, consistency and quality.
Represent the organisation in interactions with US health authorities, contributing to meeting preparation, regulatory discussions and follow-up activities.
Monitor changes in US CMC regulations and guidance, assess their impact and communicate relevant developments to stakeholders.
Develop team capabilities through coaching, feedback and knowledge sharing, while fostering a collaborative and accountable working environment.
SKILLS & EXPERIENCE
Extensive experience in CMC Regulatory Affairs, including substantial experience supporting US regulatory submissions and product lifecycle activities.
Strong knowledge of US CMC regulations, guidance and health authority expectations.
Experience leading, developing or mentoring regulatory professionals and coordinating complex, cross-functional work.
Demonstrated ability to shape regulatory strategy and provide clear, risk-based advice on complex CMC matters.
Experience managing submission planning, content review and responses to health authority questions.
Interest in driving innovation and continuous improvement in regulatory processes and operations.
Excellent written and verbal communication skills, with the ability to influence and collaborate across teams and levels of an organisation.
Strong organisational skills and the ability to manage multiple priorities in a changing environment.
A relevant scientific degree; an advanced degree is an advantage.
Qualifciations
• Degree in Science (Biology, Biochemistry, Chemistry, Bioengineering, etc.), BS/MS/Ph.D with significant industry experience in CMC regulatory affairs and in CMC regulatory affairs innovation/product development. Regulatory exposure in global regions is required.
Originally posted on Himalayas