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BSc Life Sciences Jobs | Regulatory Affairs WFH Jobs | Thermo Fisher Careers
Looking to build a rewarding future in the pharmaceutical or biotech industry? If you’re searching for BSc Life Sciences Jobs | Regulatory Affairs WFH Jobs | Thermo Fisher Careers, this opportunity could be the ideal next step. Regulatory Affairs continues to be one of the fastest-growing domains in life sciences, offering remote flexibility, global exposure, and long-term career stability. Whether you’re just starting out or aiming to advance your professional journey, this role provides a strong platform for skill development, industry relevance, and impactful work supporting global healthcare compliance.
Regulatory Affairs Specialist – CMC
Remote type: Fully Remote
Locations: Remote, India
Time type: Full-time
Posted on: Posted 2 Days Ago
Job Requisition ID: R-01335758
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Responsibilities
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Authoring and preparation of: global CMC variation submissions, annual reports and renewals, tender applications, and GMP submissions
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Comply with client’s technical information to be provided and timelines
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Provide packages for internal client review and update these as needed
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Provide finalized packages for publishing and QC published output
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Update of internal systems (RIMS, Publishing, eDMS) or documentation as needed
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Support requests for information from HAs or from partners
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Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
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Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
General required skills and qualification
Education:
University degree in life sciences or related health sciences (BS/BA/MS or equivalent), a degree in Regulatory Affairs is advantageous.
Experience:
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Minimum of 2 years’ experience in the biotech or pharmaceutical industry, with at least 2 years in Regulatory Affairs CMC.
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Knowledge in life sciences with a focus on biological/vaccines/small molecule/gene therapy medicinal products is an advantage.
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Strong regulatory CMC authoring skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements.
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Knowledge in Good Manufacturing Practice or related areas.
Technical skills
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Must be familiar and able to work with RIMS (e.g Veeva RIMS), eDMS (e.g. Veeva, Documentum) and Change Management (e.g. Trackwise) systems.
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Microsoft Office skills.
Competencies:
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Excellent communication, project management, planning and problem solving
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Strong team player with a demonstrated ability to develop constructive and effective relationships with peers and management
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Strong organizational and follow-up skills, as well as attention to detail
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Ability to work with minimal supervision based on sound technical and analytical judgment
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Flexibility to work in a global cross-cultural work environment
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Fluent in English and local language
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