**Senior CMC Regulatory Affairs Scientist**

Responsibilities

• Lead or oversee the development of US CMC technical-regulatory strategies for assigned projects as part of US or international R&D teams or in direct collaboration with contract organizations.
• Prepare comprehensive technical-regulatory gap analyses and propose regulatory scenarios with associated risk and criticality assessments aligned with business needs.
• Provide expert feedback on proposed manufacturing changes to commercialized products to ensure regulatory compliance and continuity of supply.
• Write or oversee the writing and conduct detailed reviews of post-approval submissions, US CMC technical sections, and other CMC submissions such as H submissions, protocols, and meeting briefing packages.
• Validate high-risk regulatory strategies with authorities, including preparing for and leading meetings with regulatory agencies as necessary.
• Ensure all submissions to the Center for Veterinary Medicine (CVM) are completed and submitted by agreed timelines, and proactively renegotiate timelines when needed.
• Act as a subject matter expert for pre- and post-approval CMC changes for assigned projects and products.
• Maintain accurate, up-to-date records and ensure submissions to CVM are shared, archived, and managed in accordance with departmental processes and defined timeframes.
• Provide input into technical documentation, including specifications, protocols, and reports, to support US CMC submissions and ensure studies will be acceptable to CVM.
• Identify and clearly define documentation requirements for creation of CMC technical sections and post-approval change packages, particularly with respect to registration batches.
• Design VICH-compliant regulatory stability studies for assigned R&D projects and organize and monitor their operational implementation internally or with external partners.
• Ensure stability protocols and reports are delivered in line with company practices and applicable guidelines for relevant geographic regions.
• Design studies with an international perspective to maximize global data use, reduce duplication, and optimize costs and timelines.
• Participate in inter-departmental meetings to discuss project issues and priorities and develop clear, realistic plans with milestones to achieve regulatory and business goals.
• Build and maintain long-term, effective relationships and open communication channels with domestic and international colleagues, contract organizations, and other collaborators to provide accurate information and reliable timeframes.
• Collaborate closely with pharmaceutical development and industrial operations teams to generate pre- and post-approval CMC regulatory dossiers aligned with the defined roadmap and marketing objectives.
• Work with other departments to identify process improvements and potential cost savings related to CMC and regulatory activities.
• Participate in industry working groups to help shape the regulatory landscape and stay informed of evolving expectations and best practices.
• Develop and maintain a positive working rapport with regulatory agencies and contract organizations, representing the company professionally during interactions.
• Provide regulatory support during regulatory authority site inspections, helping to prepare documentation and respond to regulatory questions.
• Mentor junior regulatory staff by creating a supportive, coaching-oriented environment that accelerates learning and enables colleagues to excel in their roles.
• Suggest and help drive improvements to team processes and other CMC-regulatory related procedures to enhance efficiency and quality.
• Travel as needed, typically 5–15%, to attend internal team meetings, industry conferences, and meetings with the FDA or other regulatory bodies.

Qualifications

• Extensive experience in regulatory submissions with a focus on CMC for pharmaceutical products.
• Strong technical writing skills, including extensive hands-on experience assembling CMC-related submissions to regulatory authorities rather than only coordinating submissions.
• Demonstrated ability to produce high-quality results with a strong sense of urgency and adherence to required timelines.
• Exceptional attention to detail and strong organizational skills to manage multiple projects and submissions concurrently.
• Prominent ability to promote collaboration across functional boundaries and work effectively with cross-functional and international teams.
• Ability to quickly grasp new concepts and assimilate and evaluate complex scientific and technical data.
• Strong knowledge of regulations and regulatory expectations, with the ability to interpret, understand, and clearly communicate regulatory language.
• Proven ability to read, understand, and retain a broad working knowledge of procedures, guidelines, and internal documentation.
• Strong communication skills with the ability to maintain open, transparent communication and build sustainable relationships with internal and external stakeholders.
• Advanced computer skills with proficiency in Microsoft Office Suite and/or Google Workspace, and Adobe Acrobat.
• Ability to adapt to changing regulatory procedures and effectively prioritize work in a dynamic environment.
• Ability to negotiate internally and externally, including with regulatory agencies, on CMC and technical topics.
• Experience with FDA regulatory processes, particularly CVM, including submission preparation and agency interactions.
• Bachelor’s degree in a scientific field such as chemistry, biology, animal science, or a related discipline, or equivalent experience.
• 6–8 years of diverse pharmaceutical regulatory experience for Lead-level candidates or 9+ years for Senior-level candidates, with at least 3 years in the veterinary pharmaceutical industry strongly preferred.
• Preference for candidates with FDA/CVM submission experience and prior participation in meetings or informal communications with the FDA, especially CVM.
• Strong preference for candidates with pre-approval submission experience in CMC.