Regulatory Affairs – CMC Consultant

Greenhouse Software, Inc.; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

ClinChoice is seeking an experienced Regulatory Affairs CMC Consultant for a 12-month contract with extension potential. You will provide regulatory CMC expertise across new product development, lifecycle management, post-approval changes, and global submissions.

Collaborate with Regulatory Affairs, R&D, Quality, and Supply Chain to develop practical strategies. The role requires strong project management, communication skills, and the ability to work independently in a client-facing

Qualifications

• Bachelor’s or Master’s degree in a related discipline.
• Strong experience in Regulatory Affairs CMC and product development.
• Familiarity with CTD Modules 2.3 and 3 and CMC submission docs.
• Knowledge of global regulatory requirements for pharmaceutical CMC.
• Experience in new product development and lifecycle management.
• Excellent cross-functional collaboration and communication.

Responsibilities

• Lead or support Regulatory CMC strategy for new product development and lifecycle programs.
• Provide CMC regulatory guidance for pharmaceutical and self-care products globally.
• Develop, review, and maintain CTD Module 2.3 and 3 documentation.
• Prepare and review CMC content for regulatory submissions.
• Assess CMC changes for regulatory impact and submission requirements.
• Advise on manufacturing, formulation, analytical methods, specifications, and stability.
• Serve as CMC representative on cross-functional teams.
• Coordinate with R&D, Manufacturing, Quality, Supply Chain, and Regulatory colleagues.
• Support regulatory agency interactions and responses on CMC queries.
• Manage regulatory risks and mitigation strategies.
• Ensure ongoing compliance and successful implementation of CMC changes.
• Contribute to process improvements and practical CMC ways of working.

Skills

Regulatory CMC strategy

Pharmaceutical product development

CTD Modules 2.3 and 3

Regulatory submissions

Cross-functional leadership

Project management

Education

Bachelor’s or Master’s in Pharmacy/Pharmaceutical Sciences/Chemistry/Life Sciences

Job description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs CMC Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

About the Role

We are seeking an experienced Regulatory CMC professional to support Client’s pharmaceutical and self-care portfolio. This role will provide regulatory CMC expertise across new product development, lifecycle management, post-approval changes, and global regulatory submissions.

The successful candidate will partner closely with Regulatory Affairs, R&D, Supply Chain, Quality, and other cross-functional teams to develop and implement effective CMC regulatory strategies.

Key Responsibilities

• Lead or support Regulatory CMC strategy for new product development and lifecycle management programs.
• Provide CMC regulatory guidance for pharmaceutical and self-care products across global markets.
• Develop, review, and maintain CTD Module 2.3 and Module 3 documentation.
• Prepare and review CMC content for regulatory submissions, including new applications, variations, and post-approval changes.
• Assess proposed CMC changes for regulatory impact, compliance, risks, and submission requirements.
• Provide regulatory guidance on manufacturing, formulation, analytical methods, specifications, stability, packaging, and related CMC topics.
• Act as the CMC representative on cross-functional product development and lifecycle management teams.
• Partner with R&D, Manufacturing, Quality, Supply Chain, and Regulatory colleagues to resolve CMC issues and develop practical regulatory strategies.
• Support regulatory agency interactions and responses to CMC-related questions, as required.
• Manage regulatory risks and develop appropriate mitigation and contingency strategies.
• Ensure ongoing regulatory compliance and successful implementation of approved CMC changes.
• Contribute to process improvements, simplification initiatives, and development of effective CMC ways of working.

Required Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related discipline.
• Strong experience in Regulatory Affairs CMC and/or pharmaceutical product development.
• Experience with CTD Modules 2.3 and 3 and CMC submission documentation.
• Knowledge of global regulatory requirements related to pharmaceutical CMC.
• Experience with new product development and post-approval lifecycle management.
• Strong understanding of CMC regulatory requirements involving manufacturing, formulation, analytical testing, specifications, and stability.
• Experience working effectively with cross-functional teams.
• Strong project management, communication, problem-solving, and stakeholder-management skills.

Preferred Experience

• Experience supporting OTC, self-care, consumer health, or pharmaceutical products.
• Experience working across multiple global markets and regulatory regions.
• Experience interacting with health authorities or supporting responses to regulatory questions.
• Ability to influence cross-functional teams and provide clear, practical regulatory guidance.

What You’ll Bring

We are looking for someone who combines strong technical CMC expertise with excellent regulatory judgment, communication, and collaboration skills. The ideal candidate will be comfortable working in a global, cross-functional environment and managing multiple CMC programs and priorities.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in ClinChoice’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

I certify all information provided in this employment application is true and complete. I understand any false information or omission may disqualify me from further consideration for employment and may result in my dismissal if discovered at a later date.

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I UNDERSTAND THIS APPLICATION OR SUBSEQUENT EMPLOYMENT DOES NOT CREATE A CONTRACT OF EMPLOYMENT NOR GUARANTEE EMPLOYMENT FOR ANY DEFINITE PERIOD OF TIME. IF EMPLOYED, I UNDERSTAND THAT I HAVE BEEN HIRED AT THE WILL OF THE EMPLOYER AND MY EMPLOYMENT MAY BE TERMINATED AT ANY TIME WITH OR WITHOUT CAUSE AND WITH OR WITHOUT NOTICE.