Company: Thermo Fisher Scientific
Location: Work From Home
Position: Country Approval Specialist in Regulatory Affairs
Salary: ₹6 – 8 Lacs Per Year
Experience: 1 to 2 Years
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc
About the Company:
At Thermo Fisher Scientific, we’re dedicated to making a positive global impact through meaningful work. Join us in advancing science and improving health outcomes through innovative research, development, and delivery of life-changing therapies. With a global presence in clinical trials and a commitment to quality and accuracy, our mission is to make the world healthier, cleaner, and safer.
Key Responsibilities:
- Regulatory Submissions: Prepare, review, and coordinate local regulatory submissions (MoH, EC, special applications) in alignment with global strategy.
- Local Strategy Advice: Provide guidance on local regulatory strategies to internal clients.
- Project Coordination: Manage local SIA services and project coordination.
- Submission Activities: Act as key contact for ethical or regulatory submission-related activities.
- Site Activation: Coordinate with internal departments to align site start-up activities with submission timelines.
- Trial Status: Enter and maintain trial status information on PPD tracking databases.
- Documentation: Develop and maintain local country study files and patient information documents.
- Feasibility Support: Assist with feasibility activities, grant budgets, and payment schedules.
Skills & Requirements:
- Knowledge of regulatory guidelines, SOPs, and client directives.
- Strong organizational skills and attention to detail.
- Ability to work independently and manage multiple projects.