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United States
Remote only
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director - US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs based in the United States.
The Director will lead the US CMC Regulatory Affairs team while shaping global regulatory strategies for veterinary pharmaceutical products across development, approval, and commercial lifecycle management. This senior leadership role combines team management, regulatory expertise, and innovation to ensure compliance with FDA requirements and applicable international regulations. The successful candidate will oversee post-approval changes, manufacturing and technology transfers, product improvements, and regulatory initiatives that support supply chain continuity and operational excellence. In parallel, the Director will guide global CMC innovation strategies for small-molecule products, supporting pipeline development, registration preparation, and market authorization across major regions. Working closely with development, manufacturing, quality, clinical, supply chain, and external manufacturing partners, the role ensures regulatory plans align with scientific, quality, and business priorities. This is an opportunity to influence global regulatory practices, develop high-performing teams, and help advance innovative veterinary medicines in a fully remote environment.
Lead the US Regulatory Affairs CMC team, establishing priorities, guiding performance, and ensuring the delivery of high-quality regulatory strategies and submissions.
Develop and implement US CMC regulatory strategies for veterinary pharmaceutical products throughout development, initial registration, commercialization, and post-approval lifecycle management.
Oversee the preparation, review, and submission of CMC documentation for US regulatory applications, amendments, supplements, and responses to health authority questions.
Provide regulatory oversight for approved products, ensuring ongoing CMC compliance and effective management of product and manufacturing changes.
Support manufacturing and supply initiatives, including technology transfers, site strategy, manufacturing changes, product and process improvements, and long-term supply chain optimization.
Lead global CMC regulatory innovation for small-molecule products, guiding strategy development and implementation for FDA, EMA, and other relevant regulatory authorities.
Partner with global CMC Regulatory Affairs colleagues and cross-functional teams spanning development, manufacturing, quality, clinical, discovery, and supply operations to align regulatory plans with project and business objectives.
Advise project teams on regulatory requirements, risks, opportunities, and complex CMC issues, recommending practical, risk-based solutions.
Represent the organization in interactions with US health authorities, supporting meeting preparation, regulatory discussions, and follow-up commitments.
Monitor evolving US CMC regulations and guidance, evaluate their potential impact, and communicate relevant updates to internal stakeholders.
Drive improvements in regulatory processes, tools, and operating practices to enhance efficiency, consistency, quality, and innovation.
Coach and develop regulatory professionals through feedback, mentoring, and knowledge sharing, fostering a collaborative, accountable, and high-performing team.
Bachelor's, master's, or doctoral degree in a relevant scientific discipline, such as Biology, Biochemistry, Chemistry, Bioengineering, or a related field.
Significant industry experience in CMC Regulatory Affairs, including substantial responsibility for US regulatory submissions, product development, and lifecycle management.
Strong knowledge of US CMC regulations, regulatory guidance, FDA requirements, and health authority expectations.
Experience developing regulatory strategies for pharmaceutical products, including post-approval changes, manufacturing changes, compliance activities, and product lifecycle initiatives.
Demonstrated experience planning, preparing, reviewing, and coordinating regulatory submissions and responses to health authority questions.
Experience with global CMC regulatory requirements and exposure to regulatory authorities across international markets.
Ability to provide strategic, risk-based advice on complex CMC matters and translate regulatory requirements into practical recommendations.
Proven experience leading, mentoring, or developing regulatory professionals and coordinating complex cross-functional initiatives.
Understanding of manufacturing operations, technology transfers, product and process improvements, and the regulatory implications of supply chain and site changes.
Interest in regulatory innovation and continuous improvement, including the development of more effective tools, processes, and ways of working.
Excellent written and verbal communication skills, with the ability to influence stakeholders, collaborate across functions, and communicate complex regulatory topics clearly.
Strong organizational and project management skills, with the ability to manage competing priorities in a dynamic, global environment.
An advanced scientific degree is an advantage.
Annual salary: $180,000–$230,000.
Remote work: Fully remote position based in the United States.
Employment type: Full-time.
Competitive benefits package: Additional benefits are described as competitive, although specific offerings were not detailed in the provided job description.
Leadership and career impact: Opportunity to lead a regulatory affairs team and shape global CMC strategy, innovation, and regulatory operations.
Global collaboration: Work across international markets with multidisciplinary teams involved in pharmaceutical development, manufacturing, quality, and regulatory strategy.
Specific details regarding healthcare coverage, retirement plans, paid time off, bonuses, and other benefits should be confirmed during the hiring process.