Senior CMC Regulatory Scientist

ACTalent; United States; Remote; USD 73,000 - 99,000; Full time

Benefits offered by this job

Remote work

Travel opportunities

Job summary

Actalent is seeking a Senior CMC Regulatory Scientist to lead U.S. regulatory strategies for veterinary products and manage FDA CVM submissions. This remote role collaborates with R&D, QA, Manufacturing, and Marketing to ensure lifecycle compliance across programs.

The ideal candidate will have extensive veterinary regulatory experience, strong regulatory writing, and proven FDA interaction performance, with travel as needed for industry meetings and conferences.

Qualifications

• Bachelor’s degree in chemistry, biology, animal science, pharmaceutical sciences, or related field, or equivalent experience.
• 6+ years of pharmaceutical regulatory experience for Lead; 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 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.

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 CVM submissions.
• Conduct CMC regulatory gap assessments and evaluate regulatory risks associated with proposed strategies.
• Review CMC submissions and supporting documentation prepared by other team members.
• Provide CMC regulatory guidance to R&D, Quality, Manufacturing, Formulation, Clinical, and Marketing teams.

Skills

CMC regulatory strategies

FDA CVM interactions

Regulatory documentation

Regulatory writing

Cross-functional collaboration

Regulatory submissions

Lifecycle management

Regulatory risk assessment

Regulatory impact assessment

Education

Bachelor's degree in a relevant scientific field

Tools

CVM eSubmitter

Job description

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 jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime 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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.