Work From Home Jobs in Regulatory Affairs As Country Approval Specialist

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.