CMC Regulatory Affairs Scientist

Actalent • Greenfield, IN • 10h ago

Job Title: CMC Regulatory Affairs Scientist

Job Description

As a CMC Regulatory Affairs Scientist, you will play a crucial role in the design and evaluation of studies to meet regulatory requirements. You will define regulatory strategies for US submissions and prepare CMC submissions to ensure their admissibility by authorities. Your efforts will be focused on growing the product portfolio and ensuring effective life cycle management.

Responsibilities

Lead or oversee the development of US CMC technical-regulatory strategies for assigned projects.

Prepare technical-regulatory gap analyses and propose scenarios with risk/criticality analysis.

Provide feedback on proposed manufacturing changes to commercialized products.

Write or oversee the writing and conduct reviews of post-approval submissions and other CMC submissions.

Validate high-risk strategies with regulatory authorities and lead meetings with them as necessary.

Ensure all submissions to CVM are submitted by agreed deadlines or renegotiate timelines if needed.

Act as a subject matter expert for pre- and post-approval changes for assigned projects/products.

Maintain up-to-date records and archive submissions to CVM per department processes.

Provide input into technical documentation to support US CMC submissions.

Design VICH regulatory stability studies and monitor their implementation.

Ensure delivery of stability protocols and reports according to company practices.

Participate in inter-departmental meetings to discuss project issues and priorities.

Build long-term relationships and open communication with domestic and international collaborators.

Collaborate with pharmaceutical development and industrial operations teams to generate CMC regulatory dossiers.

Participate in industry working groups to help shape the regulatory landscape.

Develop and maintain positive working relationships with governing regulatory agencies.

Provide regulatory support during regulatory authority site inspections.

Mentor junior regulatory staff and provide a supportive environment for learning.

Suggest and drive improvements to team processes and CMC-regulatory related processes.

Essential Skills

Regulatory submission experience with FDA and CMC.

Strong technical writing skills.

Attention to detail and strong organizational skills.

Ability to grasp new concepts quickly and evaluate scientific data.

Knowledge of and ability to communicate regulations and regulatory language.

Advanced computer skills, including proficiency in Microsoft Office Suite and Adobe Acrobat.

Ability to negotiate internally and externally with regulatory agencies.

Additional Skills & Qualifications

Bachelor's degree in a scientific field or equivalent experience.

6-8 years (Lead) or 9+ years pharmaceutical regulatory experience, with 3 years in veterinary pharmaceutical industry preferred.

Experience with FDA/CVM submissions.

Previous interaction with the FDA and preference for experience interacting with CVM.

Work Environment

This is a 100% remote role with standard office hours from 9:00 AM to 3:00 PM, Monday to Friday. The work environment is supportive, encouraging a mentor/coach relationship. Open communication is fostered, allowing for good conversations and knowledge sharing. Travel for team meetings or industry conferences is expected. The culture is driven by a passion for animals, with opportunities for volunteering and involvement in animal-related causes. The company offers great benefits and a positive work/life balance.

Job Type & Location

This is a Contract to Hire position based out of Bridgeton, Missouri.

Pay and Benefits

The pay range for this position is $53.00 - $65.00/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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 16, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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