Thermo Fisher Scientific is hiring for the Country Approval Specialist position in India. This is a fully remote, full-time opportunity supporting clinical trial regulatory submissions, Ethics Committee (EC) activities, Ministry of Health (MoH) submissions, site start-up activities, informed consent documentation, and regulatory compliance.
The Thermo Fisher Scientific Country Approval Specialist job can be a strong opportunity for candidates looking to build a career in clinical research, regulatory affairs, clinical trial submissions, or study start-up. Candidates with a bachelor’s degree or equivalent qualification and approximately 0–2 years of relevant experience may be considered.
About the Country Approval Specialist Role
The Country Approval Associate supports the preparation, review, and coordination of country-level clinical trial submissions in accordance with global submission strategies.
The professional works with internal functional teams, clinical research associates, investigators, and study sites to help ensure regulatory and Ethics Committee activities remain aligned with site activation timelines.
Key Responsibilities
- Prepare, review, and coordinate local Ethics Committee (EC) submissions under appropriate guidance.
- Support preparation of local Ministry of Health (MoH) submissions where applicable.
- Coordinate with internal functional departments regarding site start-up and submission activities.
- Ensure regulatory submission activities remain aligned with critical site activation timelines.
- Support achievement of targeted site start-up cycle times.
- Communicate with investigators regarding submission-related activities when required.
- Serve as a country-level contact for Ethics Committee or regulatory submission activities when assigned.
- Work with start-up CRAs to prepare regulatory compliance review packages.
- Assist with development of country-specific Patient Information Sheets and Informed Consent Forms (ICFs).
- Support site grant budget and payment schedule negotiations.
- Enter and maintain accurate study and site initiation activity information in company or client tracking databases.
- Maintain local country study files and appropriate filing processes.
- Follow applicable PPD SOPs, client SOPs, work procedures, and regulatory guidelines.
Qualifications
Thermo Fisher Scientific states that candidates should have a Bachelor’s degree or equivalent relevant academic/vocational qualification.
Relevant educational backgrounds may include, depending on the candidate’s knowledge and experience:
B.Pharm, Pharm.D, B.Sc Life Sciences, B.Sc Biotechnology, B.Sc Microbiology, B.Sc Biochemistry, B.Sc Clinical Research, B.Sc Nursing, and other relevant health, science, or life-science bachelor’s degrees.
Candidates with relevant postgraduate qualifications such as M.Pharm, M.Sc Life Sciences, M.Sc Biotechnology, M.Sc Microbiology, M.Sc Biochemistry, M.Sc Clinical Research, or other relevant master’s degrees may also be suitable, subject to the employer’s screening criteria.
Important: The official job description specifies a bachelor’s degree or equivalent qualification but does not restrict eligibility to the individual degree specializations listed above. Final eligibility is determined by Thermo Fisher Scientific.
Experience Required
Candidates should generally have 0–2 years of relevant experience or equivalent education, training, and directly related experience sufficient to perform the responsibilities of the position.
This makes the Country Approval Specialist opportunity potentially relevant to early-career professionals seeking exposure to clinical trial regulatory affairs and study start-up activities.
Skills Required
Candidates should possess:
- Effective written and verbal communication skills
- Strong attention to detail
- Good documentation practices
- Interpersonal and collaboration skills
- Negotiation skills
- Good computer proficiency
- Ability to learn relevant clinical research software
- Strong English language and grammar skills
- Basic medical and therapeutic-area knowledge
- Understanding of medical terminology
- Organizational and planning skills
- Ability to work independently and within cross-functional teams
- Basic knowledge of applicable national and regional regulatory requirements
- Basic understanding of Ethics Committee regulations
Knowledge of ICH-GCP, clinical trial documentation, EC submissions, regulatory submissions, informed consent documentation, and clinical trial site start-up can be particularly relevant to this type of position.
Why Consider This Opportunity?
The Country Approval Specialist job at Thermo Fisher Scientific provides exposure to an important part of clinical trial execution: obtaining and coordinating regulatory and ethics approvals required for study and site activation.
The role offers opportunities to develop practical experience in areas such as:
- Clinical trial regulatory submissions
- Ethics Committee submissions
- Ministry of Health submissions
- Site initiation and start-up
- Regulatory documentation
- Informed Consent Forms
- Clinical trial tracking systems
- Investigator and site communication
- Regulatory compliance
- Cross-functional clinical operations
These competencies can support longer-term career development in study start-up, regulatory affairs, clinical operations, and clinical research project management.
How to Apply
