Thermo Fisher Scientific Careers: Country Approval Specialist | Pharma Jobs Mumbai
Explore exciting growth opportunities with Thermo Fisher Scientific careers through this Country Approval Specialist role, one of the most in-demand Pharma Jobs Mumbai offers today. This position is ideal for professionals looking to build a strong future in clinical research, regulatory approvals, and global clinical operations.
Job Details:
- Job Title: Country Approval Specialist
- Location: Mumbai, Maharashtra, India
- Job Id: R-01331388
About The Company
Thermo Fisher Scientific is the world leader in serving science, enabling customers to make the world healthier, cleaner and safer. Through its global brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD, the company delivers innovative technologies and pharmaceutical services worldwide, making it a preferred destination for Thermo Fisher Scientific careers and top Pharma Jobs Mumbai.
Job Description
Thermo Fisher Scientific is seeking a highly skilled Country Approval Specialist to join our Clinical Operations team in India. This outstanding opportunity lets you lead/excel in the clinical operations team and collaboration. As a vital team member, you will ensure flawless execution of study startup phase, meeting all regulatory requirements and industry standards.
Key Responsibilities at Thermo Fischer Scientific Careers
- Determine and prepare country-specific submission dossiers for DCGI & EC meeting regulatory requirements for clinical trial submissions.
- Successfully implement submission strategies to acquire regulatory and ethics committee approvals.
- Forecast timelines for the critical activities.
- Liaise with regulatory authorities and investigators to facilitate approval processes.
- Collaborate with cross-functional teams to ensure timely and accurate documentation, optimise study startup timelines.
- Obtain and review essential documents, ensure systems updation and filing.
- Monitor and ensure compliance with local and international regulations.
- Work and drive the amendments and support the ongoing submissions, notifications for the ongoing studies.
- Provide guidance and support to project teams on local regulatory and GCP requirements, timelines and strategy.
Qualifications Required For Thermo Fischer Scientific Careers
- Demonstrated background in clinical trials (clinical operations) study startup & / or regulatory affairs.
- Strong knowledge of clinical trial regulations and guidelines.
- Outstanding organizational skills and attention to detail.
- Ability to collaborate effectively with diverse teams.
- Excellent communication and interpersonal skills.
- Bachelor’s degree in Pharmacy, or a related field.
Why Join This Company?
At Thermo Fisher Scientific, we offer an ambitious and inclusive work environment where your contributions are valued and recognized. You will have the opportunity to compete on a global scale, working alongside dedicated professionals to make a tangible impact. Join us and be part of a team that drives world-class research and innovation!
