Senior CMC Regulatory Scientist

Job Title: Senior CMC Regulatory Scientist Job Description The Senior CMC Regulatory Scientist will be responsible for developing and executing U.S. CMC regulatory strategies for veterinary pharmaceutical products. This individual will manage regulatory submissions, evaluate manufacturing and product changes, conduct regulatory gap and risk assessments, and provide CMC guidance to cross-functional teams. The role will support both R&D programs and post-approval product lifecycle management. Responsibilities Develop U.S. CMC regulatory strategies for assigned R&D and commercial product programs. Prepare, review, and submit CMC regulatory documentation, including R&D submissions, post-approval submissions, annual reports, and regulatory correspondence. Manage submission timelines and coordinate the collection of technical documentation required for FDA Center for Veterinary Medicine submissions. Conduct CMC regulatory gap assessments and evaluate regulatory risks associated with proposed strategies. Assess manufacturing, formulation, and other product changes for potential regulatory impact. Recommend submission strategies and regulatory pathways based on technical requirements, risk, and business needs. Review CMC submissions and supporting documentation prepared by other team members. Prepare for and participate in meetings and communications with FDA and other regulatory authorities. Monitor changes to U.S. pharmaceutical regulations and communicate relevant requirements to CMC and cross-functional teams. Provide CMC regulatory guidance to R&D, Quality, Manufacturing, Formulation, Clinical, and Marketing teams. Support regulatory authority inspections and product registration maintenance activities. Essential Skills Bachelors degree in chemistry, biology, animal science, pharmaceutical sciences, or related scientific field, or equivalent relevant experience. 6+ years of pharmaceutical regulatory experience for Lead level; 9+ years for Senior level. Minimum 3 years of regulatory experience in veterinary pharmaceuticals/animal health. Experience developing and executing U.S. CMC regulatory strategies. Hands-on experience preparing CMC regulatory submissions, including R&D, post-approval, and/or lifecycle management submissions. Strong working knowledge of U.S. pharmaceutical regulations and CMC requirements. Previous experience interacting with FDA, including regulatory submissions, correspondence, and/or agency meetings. Ability to assess manufacturing/product changes, regulatory gaps, and CMC risks and determine regulatory impact. Strong technical and regulatory writing/review skills. Additional Skills & Qualifications Direct experience working with FDA Center for Veterinary Medicine (CVM). Experience with CVM eSubmitter or similar electronic regulatory submission tools. Experience supporting or leading meetings with regulatory authorities. Experience reviewing CMC submissions prepared by other regulatory team members. Experience providing CMC regulatory guidance to cross-functional groups such as R&D, Quality, Manufacturing, Formulation, and Clinical. Experience supporting regulatory authority inspections. Work Environment This is a 100% remote role with standard office hours (9:00 - 3:00 core hours) Monday - Friday. The culture is supportive, fostering a mentor/coach relationship, where team members work collaboratively. Expect travel responsibilities for team meetings or industry conferences. 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. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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) Job Type & Location This is a Contract position based out of Bridgeton, MO. Application Deadline This position is anticipated to close on Nov 23, 2026. Workplace Type This is a fully remote position. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr ACTalent