[Remote] Regulatory Affairs Specialist - CMC at Thermo Fisher Scientific

India

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalIndustries

Requirements

University degree in life sciences or related health sciences (BS/BA/MS or equivalent); degree in Regulatory Affairs advantageous
Minimum of 2 years’ experience in the biotech or pharmaceutical industry, with at least 2 years in Regulatory Affairs CMC
Knowledge in life sciences with focus on biological/vaccines/small molecule/gene therapy medicinal products advantageous
Strong regulatory CMC authoring skills and ability to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements
Knowledge in Good Manufacturing Practice or related areas
Familiarity and ability to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva, Documentum), and Change Management (e.g., Trackwise) systems
Microsoft Office skills
Excellent communication, project management, planning, and problem-solving skills
Strong team player with ability to develop constructive and effective relationships with peers and management
Strong organizational and follow-up skills, as well as attention to detail
Ability to work with minimal supervision based on sound technical and analytical judgment
Flexibility to work in a global cross-cultural work environment
Fluent in English and local language

Responsibilities

Authoring and preparation of global CMC variation submissions, annual reports and renewals, tender applications, and GMP submissions
Comply with client’s technical information to be provided and timelines
Provide packages for internal client review and update these as needed
Provide finalized packages for publishing and QC published output
Update internal systems (RIMS, Publishing, eDMS) or documentation as needed
Support requests for information from HAs or from partners
Collaborate extensively with other departments, regulatory consultants, and regulatory authorities
Assist in identifying and recognizing out-of-scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications

Skills

Key technologies and capabilities for this role

CMCRegulatory AffairsVeeva RIMSeDMSDocumentumTrackwiseGMPMicrosoft Officeproject management

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A university degree in life sciences or related health sciences (BS/BA/MS or equivalent) is required, with a degree in Regulatory Affairs advantageous. Minimum of 2 years’ experience in the biotech or pharmaceutical industry, with at least 2 years in Regulatory Affairs CMC.

What technical skills are needed for this position?

Familiarity with RIMS (e.g. Veeva RIMS), eDMS (e.g. Veeva, Documentum), and Change Management (e.g. Trackwise) systems is required, along with Microsoft Office skills. Strong regulatory CMC authoring skills and knowledge in Good Manufacturing Practice are also essential.

Is this a remote position, or does it require office work?

The role is based in an office environment with a standard Monday-Friday work schedule.

What is the salary or compensation for this role?

This information is not specified in the job description.

What competencies make a strong candidate for this position?

Excellent communication, project management, planning, problem-solving, strong team player abilities, organizational skills, attention to detail, ability to work with minimal supervision, flexibility in a global environment, and fluency in English and local language.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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