Senior Chemistry, Manufacturing, and Controls Regulatory Affairs Scientist

Title: Senior CMC Regulatory Affairs Scientist

Location: Bridgeton, MO

Remote

Job Description:

The CMC Regulatory Affairs Scientist leads the design and evaluation of chemistry, manufacturing, and controls (CMC) studies to meet regulatory requirements and defines robust regulatory strategies for United States submissions. This role prepares and oversees CMC submissions to ensure they meet regulatory expectations and support product portfolio growth and lifecycle management. The position serves as a technical-regulatory expert, partnering closely with R&D, pharmaceutical development, industrial operations, and external partners to optimize regulatory strategies, streamline data use globally, and support both pre- and post-approval activities.

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.
• Support new and existing CMC team members by sharing learnings, best practices, and institutional knowledge.
• 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.

Essential Skills

• 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.
• Ability to design, evaluate, and interpret CMC studies and stability programs in alignment with regulatory requirements and VICH guidelines.
• 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.
• Proven 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.
• 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 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.

Additional Skills & Qualifications

• Experience in veterinary pharmaceutical regulatory affairs, including familiarity with CVM expectations and processes.
• Experience in chemistry, manufacturing, and controls, including understanding of manufacturing processes and related regulatory requirements.
• Experience designing or overseeing VICH-compliant stability studies and leveraging data for multiple geographic regions.
• Experience with CVM eSubmitter or similar electronic submission tools is a plus.
• Demonstrated ability to contribute to process improvement initiatives within regulatory or CMC functions.
• Experience participating in industry working groups or professional forums related to regulatory affairs.
• Proven mentoring or coaching experience, particularly in supporting junior regulatory professionals.
• Comfort working in a distributed, remote team environment and maintaining strong virtual communication.
• Interest in or affinity for animal health, including alignment with a mission-oriented culture focused on animal well-being.

Job Type & Location

This is a Contract position based out of Bridgeton, MO.

Pay and Benefits

The pay range for this position is $53.00 - $72.12/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)