Thermo Fisher Work From Home Hiring Country Approval Specialist

Country Approval Specialist | Thermo Fisher | Mumbai

Apply for Country Approval Specialist at Thermo Fisher, Mumbai. BSc Life Sciences/Pharmacy graduates with clinical research and regulatory experience welcome.

Elevate your career in clinical research and regulatory affairs with Thermo Fisher Scientific as a Country Approval Specialist in Mumbai, India. This role offers an exceptional opportunity to contribute to study startup, clinical trial compliance, and regulatory submissions, accelerating drug development and improving healthcare outcomes worldwide.

Company Overview

Thermo Fisher Scientific is a globally recognized contract research organization (CRO) delivering advanced solutions in clinical trials, regulatory affairs, and life sciences research. Our teams bring unmatched scientific expertise and regulatory knowledge to support pharmaceutical and biotech clients, ensuring efficient and compliant clinical research operations.

With a commitment to innovation, integrity, and collaboration, Thermo Fisher fosters a dynamic environment where professionals contribute to high-impact clinical research and drug development projects.

Job Role & Responsibilities

As a Country Approval Specialist, you will play a pivotal role in ensuring regulatory compliance and study startup efficiency for clinical trials. You will coordinate cross-functional operations, manage documentation, and support approvals across multiple stakeholders.

Key Responsibilities:

  • Prepare and submit country-specific regulatory dossiers for DCGI & Ethics Committees (EC) in compliance with clinical trial regulations and GCP guidelines.
  • Implement submission strategies to secure regulatory approvals and ethics committee clearance, forecasting timelines and critical milestones.
  • Liaise with regulatory authorities, investigators, and clinical teams to facilitate smooth approval processes.
  • Maintain project trackers, essential documents, and regulatory filings to optimize study startup timelines.
  • Monitor ongoing submissions, manage amendments, notifications, and regulatory updates.
  • Provide guidance to project teams on local regulatory requirements, GCP compliance, and clinical trial strategy.
  • Support clinical operations, CRO management, and regulatory affairs projects ensuring timely delivery and compliance.

This role is ideal for professionals seeking growth in clinical research operations, regulatory affairs, and CRO-based careers.

Eligibility / Qualifications

  • Educational Qualification: Bachelor’s degree in Life Sciences, Pharmacy, or related fields.
  • Experience in clinical trials, study startup, regulatory affairs, or CRO project management.
  • Knowledge of DCGI guidelines, GCP compliance, and clinical trial regulations.
  • Excellent organizational, communication, and team collaboration skills.
  • Detail-oriented with the ability to manage multiple clinical projects efficiently.

Preferred Courses: BSc Life Sciences, BPharm, MSc Life Sciences, MSc Pharmacy, Biotechnology, Clinical Research, Regulatory Affairs.

Location & Work Type

  • Location: Mumbai, Maharashtra, India
  • Job Type: Full-Time, Remote option available
  • Work Schedule: Standard Monday–Friday

Thermo Fisher provides a flexible, inclusive work environment promoting work-life balance while delivering high-quality clinical research solutions.

Application Process

Advance your career in high CPC clinical research and regulatory affairs jobs by joining a globally recognized CRO:

👉 Apply Now on Thermo Fisher Careers

Apply early to secure your opportunity to work on regulatory submissions, clinical trial compliance, and study startup excellence.

Why Join Thermo Fisher Scientific?

  • Work with a leading global CRO impacting clinical research worldwide.
  • Gain hands-on experience in regulatory affairs, clinical operations, and study startup.
  • Collaborate with dedicated cross-functional teams on high-impact projects.
  • Enjoy a dynamic, inclusive, and flexible work culture.
  • Contribute to high-value clinical research projects that advance healthcare and patient outcomes.

FAQs

Q1: Who can apply for this position?
Graduates in Life Sciences or Pharmacy with experience in clinical research, study startup, or regulatory affairs.

Q2: Is prior regulatory submission experience required?
Yes, familiarity with DCGI & EC submissions, GCP compliance, and clinical operations is preferred.

Q3: Where is the job located?
The position is based in Mumbai, India, with a remote option.

Q4: What are the work hours?
Standard Monday–Friday schedule.

Q5: How can I apply?
Submit your application using the official Thermo Fisher Careers link.

Call to Action:
Join Thermo Fisher Scientific and accelerate your career in clinical research, regulatory affairs, and CRO operations. Apply now to become a key contributor to global healthcare innovation!

Company Thermo Fisher Scientific
Vacancies Full-Time, Remote/Office
Required Education BSc Life Sciences, BPharm, MSc Life Sciences, MSc Pharmacy, Biotechnology, Clinical Research, Regulatory Affairs
Experience Clinical operations, study startup, or regulatory affairs expertise
Location Mumbai, Maharashtra, India
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