Thermo Fisher Scientific Hiring for Regulatory Affairs Specialist CMC
Thermo Fisher Scientific Hiring for Regulatory Affairs Specialist – CMC | Fully Remote Job in India
Position: Regulatory Affairs Specialist – CMC
Company: Thermo Fisher Scientific
Qualification: Bachelor’s/Master’s in Life Sciences, Pharmacy, or related health sciences
Experience Required: Minimum 2 years
Job Type: Full-Time, Remote
Application Mode: Online
Verified Job Opportunity
Thermo Fisher Scientific, one of the world’s leading biotechnology and life sciences companies, is inviting applications for the role of Regulatory Affairs Specialist – CMC. This position is ideal for professionals who have strong experience working with regulatory submissions, GMP documentation, and global CMC regulatory processes. Thermo Fisher Scientific Hiring for Regulatory Affairs Specialist CMC
As regulatory compliance continues to expand across international markets, this fully remote position allows you to collaborate with global teams, contribute to high-impact regulatory projects, and gain exposure to advanced regulatory systems. The role is tailored for individuals who are detail-oriented, technically strong, and committed to ensuring regulatory excellence. Thermo Fisher Scientific Hiring for Regulatory Affairs Specialist CMC
About the Role
The Regulatory Affairs Specialist – CMC will be responsible for preparing, reviewing, and managing Chemistry, Manufacturing, and Controls (CMC) documentation for global regulatory submissions. This includes variation submissions, renewals, annual reports, tender documents, and GMP compliance packages. The position requires close coordination with cross-functional teams and the ability to handle regulatory queries from global health authorities. Thermo Fisher Scientific Hiring for Regulatory Affairs Specialist CMC
This opportunity allows you to work on diverse regulatory projects while using industry-standard systems such as RIMS, eDMS, and change-control tools. If you have strong CMC regulatory experience and are looking for a flexible remote job with global impact, this role is an excellent fit. Thermo Fisher Scientific Hiring for Regulatory Affairs Specialist CMC
Key Responsibilities
As part of the Regulatory Affairs CMC team, your primary responsibilities will include:
1. Preparation and Authoring
- Prepare, draft, and author CMC variation submissions, renewals, annual reports, and tender applications.
- Support GMP-related submissions ensuring compliance with global regulatory requirements.
- Ensure technical accuracy and completeness of all regulatory documents.
2. Review and Compliance
- Review regulatory packages based on client requirements.
- Ensure adherence to submission timelines and project deadlines.
- Provide finalized submissions for publishing and quality control review.
3. Documentation and System Updates
- Update internal systems including RIMS (e.g., Veeva RIMS), eDMS platforms (e.g., Documentum or Veeva), and change management tools such as TrackWise.
- Maintain accurate documentation aligned with regulatory standards and organizational guidelines.
4. Communication & Collaboration
- Collaborate with internal teams, regulatory professionals, consultants, and global partners.
- Respond to regulatory authority queries and partner information requests.
- Identify out-of-scope activities within client contracts and coordinate to ensure proper handling.
Required Qualifications
Educational Requirements
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or other relevant health science disciplines.
- A specialized degree in Regulatory Affairs is an added advantage.
Experience
- Minimum 2 years of hands-on experience in Regulatory Affairs CMC within the pharmaceutical or biotechnology industry.
- Experience in biologics, vaccines, small molecules, or gene therapy products will be a strong asset.
Domain Knowledge
- Strong understanding of global regulatory guidelines.
- Familiarity with GMP requirements and regulatory compliance documentation.
- Excellent knowledge of CMC processes, data evaluation, and quality standards.
Technical Skills Required
Candidates must demonstrate proficiency in: Thermo Fisher Scientific Hiring for Regulatory Affairs Specialist CMC
- RIMS platforms such as Veeva RIMS.
- eDMS systems including Veeva or Documentum.
- Change Management systems such as TrackWise.
- Strong Microsoft Office skills and advanced document-writing capabilities.
- Ability to analyze scientific and technical CMC data.
Competencies Needed
The ideal candidate will have:
- Excellent written and verbal communication skills.
- Strong project management and planning abilities.
- High attention to detail and organizational skills.
- Ability to work independently with minimal supervision.
- Capacity to thrive in a global, cross-cultural, and collaborative work environment.
- Analytical mindset with strong problem-solving skills.
Benefits of Working at Thermo Fisher Scientific
This role offers several advantages for candidates seeking global exposure and flexible work conditions: Thermo Fisher Scientific Hiring for Regulatory Affairs Specialist CMC
- 100% remote work from anywhere in India
- Hands-on experience with global regulatory submissions
- Interaction with cross-functional international teams
- Skill enhancement in advanced regulatory tools and technology
- Opportunities to work on high-impact regulatory projects
- Strong career-growth potential within a global organization
Job Location
Remote — India
This role is fully remote, allowing candidates to work from any location while contributing to global regulatory operations. Thermo Fisher Scientific Hiring for Regulatory Affairs Specialist CMC
Key Box (Highlighted Section)
Position: Regulatory Affairs Specialist – CMC
Company: Thermo Fisher Scientific
Qualification: Bachelor’s/Master’s in Life Sciences / Pharmacy
Experience: Minimum 2 Years in Regulatory Affairs CMC
Job Type: Full-Time Remote
Special Skills: RIMS, eDMS, TrackWise, GMP documentation
Location: Remote (India)
Application Mode: Online
How to Apply
Candidates who meet the eligibility criteria can apply online through the official application link provided by the company. Thermo Fisher Scientific Hiring for Regulatory Affairs Specialist CMC
Submit your updated resume along with relevant experience details, and ensure your profile highlights your CMC regulatory expertise.
Remote job for Regulatory Affairs Specialist CMC at Thermo Fisher Scientific requiring 2 years experience in regulatory submissions and documentation. Thermo Fisher Scientific Hiring for Regulatory Affairs Specialist CMC
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