Work as Country Approval Specialist at Thermo Fisher Scientific Inc

Thermo Fisher Scientific Inc is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of 13 billion USD, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management.

Post : Country Approval Specialist

Job Description
• Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy.
• Support preparation, under guidance, of local MoH submissions, as applicable in
• alignment with global submission strategy.
• Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieve company’s target cycle times for site.
• May have contact with investigators for submission related activities.
• May act as a key-contact at country level for either Ethical or Regulatory submission-related activities.
• Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• Assist in developing country specific Patient Information Sheet/Informed Consent form documents.
• Assist with grant budgets(s) and payment schedules negotiations with sites.
• Enter and maintain trial status information relating to SIA activities onto company, or client (where contracted) tracking databases in an accurate and timely manner
• Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Candidate Profile
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

Knowledge, Skills, Abilities :
• Effective oral and written communication skills
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good computer skills and the ability to learn appropriate software
• Good English language and grammar skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, under direction, as required
• Basic organizational and planning skills
• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations.

Additional Information
Experience : 0 to 2 years
Qualification : Bachelor's degree
Location : Remote, India
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R-01364654
End Date : 30th September 2026