Thermo Fisher Hiring Regulatory Affairs Specialist – CMC

Regulatory Affairs CMC Specialist – Life Science Degree | Remote India

Hiring Regulatory Affairs CMC Specialist in India. Remote role for life-science graduates with 2+ years CMC experience. Apply now.

This remote Regulatory Affairs Specialist – CMC position supports global regulatory submissions for biologicals, vaccines, small molecules and gene therapy products. The role involves authoring, reviewing and compiling CMC documentation in line with global regulatory requirements for a leading CRO supporting high-impact clinical research programs. Candidates with strong regulatory writing skills, CMC expertise and hands-on experience with RIMS and eDMS platforms will fit well into this role.

Company Overview

This position is part of a world-leading contract research organization supporting global clinical research programs and advancing therapies for major health challenges. The Regulatory Affairs team ensures compliant CMC submissions that drive successful clinical and commercial regulatory pathways. The environment blends scientific rigor, structured processes and cross-functional collaboration across global teams.

Job Role & Responsibilities

Core Responsibilities

• Author and prepare CMC variation submissions, renewals, annual reports and GMP-related filings.
• Develop tender applications and support global regulatory strategy implementation.
• Review client technical information and ensure submissions meet regulatory timelines.
• Prepare packages for internal client review, update deliverables and finalize for publishing.
• Oversee QC of published output to ensure accuracy and compliance.
• Update internal systems including RIMS, Publishing and eDMS platforms.
• Support responses to Health Authority information requests.

Cross-Functional Collaboration

• Collaborate with internal departments, external consultants and regulatory authorities.
• Identify out-of-scope contract activities and coordinate with relevant stakeholders.
• Support contract modifications through correct documentation and communication.

Eligibility / Qualifications

Education

• University degree in Life Sciences or related fields: B.Sc, B.Tech Biotechnology, M.Sc Life Sciences, M.Pharm, B.Pharm, B.Sc Biotech, Microbiology, Biochemistry.
• A degree in Regulatory Affairs is an added advantage.

Experience

• Minimum 2 years of experience in biotech or pharmaceutical industry.
• At least 2 years in Regulatory Affairs – CMC.
• Experience with biologicals, vaccines, small molecules or gene therapy products is preferred.

Technical Skills

• Proficiency with RIMS systems (e.g., Veeva RIMS), eDMS platforms (e.g., Veeva, Documentum) and Change Management tools (e.g., TrackWise).
• Strong Microsoft Office capability.
• Knowledge of GMP principles and CMC regulatory requirements.

Competencies

• Strong project management, organization and communication skills.
• Ability to interpret scientific and technical CMC data with compliance focus.
• Detail-oriented with strong analytical judgment.
• Ability to work independently in a remote, cross-cultural environment.
• Fluent in English and local language.

Location & Salary

Location: Fully Remote – India.
Salary will align with experience in CMC regulatory roles and global CRO standards.

Application Process

Interested candidates can apply through the official link below:
Apply Here: https://jobs.thermofisher.com/global/en/job/R-01335758/Regulatory-Affairs-Specialist-CMC

Ensure you have an updated CV reflecting CMC writing experience, regulatory platform skills and industry background.

FAQs

1. Is this a fully remote role?
Yes. The position is fully remote within India.

2. What is the minimum experience required?
At least 2 years in Regulatory Affairs CMC within biotech or pharma.

3. Are life science graduates eligible?
Yes. Degrees in life sciences, pharmacy and regulatory sciences are accepted.

4. What technical systems should I know?
RIMS, eDMS and Change Management tools such as TrackWise.

5. Does the role involve global submissions?
Yes. The role supports global CMC submissions, renewals and variation filings.

Summary Table

Category	Details
Company	Global CRO (PPD® Clinical Research Portfolio)
Vacancies	Regulatory Affairs Specialist – CMC
Required Education	Life Sciences, B.Pharm, M.Pharm, M.Sc, Regulatory Affairs
Experience	2+ years in Regulatory Affairs CMC; 2+ years industry experience