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Title
Text copied to clipboard!CMC Specialist
Description
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We are looking for a CMC Specialist to support the development, documentation, and lifecycle management of chemistry, manufacturing, and controls activities for pharmaceutical, biotechnology, or related regulated products. In this role, you will serve as a key contributor to the preparation, review, and maintenance of CMC documentation required for regulatory submissions, product development milestones, technical transfers, and post-approval changes. You will work closely with cross-functional teams including Regulatory Affairs, Quality Assurance, Manufacturing, Analytical Development, Process Development, Supply Chain, and external partners to ensure that product information is accurate, complete, compliant, and aligned with global regulatory expectations.
The ideal candidate has a strong understanding of pharmaceutical development and manufacturing processes, as well as the structure and content of CMC sections within regulatory dossiers. You should be comfortable organizing complex technical data, identifying documentation gaps, coordinating timelines, and supporting responses to health authority questions. This position requires excellent attention to detail, strong communication skills, and the ability to manage multiple priorities in a fast-paced, highly regulated environment.
As a CMC Specialist, you will help compile data related to drug substance, drug product, raw materials, specifications, analytical methods, stability programs, manufacturing processes, validation activities, and change controls. You will contribute to the authoring and review of submission-ready documents for investigational, marketing, and lifecycle applications across different regions. You may also support internal audits, inspection readiness efforts, and document harmonization initiatives to improve consistency and compliance across programs.
Success in this role depends on your ability to translate technical manufacturing and quality information into clear, well-structured regulatory content. You should be proactive in collaborating with subject matter experts, tracking deliverables, and ensuring that documentation reflects current processes and approved data. A strong awareness of data integrity, quality systems, and global regulatory standards is essential.
This is an excellent opportunity for a detail-oriented professional who enjoys working at the intersection of science, manufacturing, quality, and regulatory compliance. If you are motivated by accuracy, cross-functional teamwork, and the challenge of supporting products throughout their development and commercial lifecycle, this role offers meaningful impact and long-term career growth.
Responsibilities
Text copied to clipboard!- Prepare, review, and maintain CMC documentation for regulatory submissions and lifecycle activities.
- Coordinate with cross-functional teams to collect technical data for dossiers and amendments.
- Support the compilation of information on drug substance, drug product, and manufacturing processes.
- Track document timelines, version control, and submission readiness across multiple projects.
- Assist in responding to health authority questions related to CMC content and supporting data.
- Review change controls and assess documentation impacts on regulatory filings and product records.
- Ensure consistency, accuracy, and compliance of CMC documents with internal and external standards.
- Support technical transfer documentation and updates associated with manufacturing site changes.
- Contribute to inspection readiness and audit support by organizing relevant CMC records.
- Identify documentation gaps and work with subject matter experts to resolve issues promptly.
Requirements
Text copied to clipboard!- Bachelor’s degree in pharmacy, chemistry, biotechnology, life sciences, or a related field.
- Experience in CMC, regulatory affairs, quality, or pharmaceutical manufacturing documentation.
- Understanding of pharmaceutical development, manufacturing, and quality system principles.
- Familiarity with regulatory submission structures such as CTD or eCTD is preferred.
- Strong technical writing, document management, and organizational skills.
- Ability to interpret scientific and manufacturing data accurately and clearly.
- Attention to detail and commitment to compliance in regulated environments.
- Experience collaborating with cross-functional teams and external partners.
- Proficiency with document control systems and standard office software.
- Good communication skills and ability to manage multiple deadlines effectively.
Potential interview questions
Text copied to clipboard!- What experience do you have with CMC documentation in regulated industries?
- Have you supported CTD or eCTD submissions? Please describe your role.
- How do you ensure accuracy and consistency in technical regulatory documents?
- What types of manufacturing or analytical data have you compiled for submissions?
- How do you manage competing deadlines across multiple projects?
- Describe your experience working with Regulatory Affairs, Quality, and Manufacturing teams.
- Have you ever supported responses to health authority questions?
- What document management systems or quality systems have you used?
