Looking for a Regulatory Affairs Executive API job in Gurugram? Fresenius Kabi Oncology Ltd. has announced an exciting opportunity for professionals in Pharmacy, Chemistry, and Life Sciences. The company is hiring a Research Scientist – Regulatory Affairs (API) at its Gurugram office. Candidates with 1-3 years of experience and strong knowledge of ICH and USFDA guidelines are encouraged to apply.
This Research Scientist Regulatory Affairs job offers exposure to Drug Master Files (DMF), API documentation, regulatory compliance, and global pharmaceutical regulations, making it an excellent career opportunity for regulatory affairs professionals.
Job Details
| Particulars | Details |
|---|---|
| Position | Research Scientist – Regulatory Affairs (API) |
| Company | Fresenius Kabi Oncology Ltd. |
| Location | Sector 32, Gurugram, Haryana |
| Experience | 1-3 Years |
| Qualification | Degree in Pharmacy, Chemistry, or Life Sciences |
| Salary | ₹3,00,000 – ₹6,00,000 per annum (Estimated) |
| Job Type | Full-Time |
Key Responsibilities
As a Research Scientist – Regulatory Affairs, the selected candidate will be responsible for:
- Evaluation of impurities, specifications, and quality-related data.
- Review of R&D documents and analytical documentation related to APIs.
- Review, preparation, and management of Drug Master Files (DMF).
- Ensuring compliance with ICH, USFDA, and global regulatory requirements.
- Supporting regulatory submissions and documentation activities.
- Coordinating with cross-functional teams to ensure timely regulatory compliance.
- Maintaining regulatory records and supporting audit readiness.
Required Qualifications
Candidates applying for this Regulatory Affairs Executive API vacancy should possess:
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, or Life Sciences.
- 1-3 years of relevant experience in Regulatory Affairs.
- Strong understanding of ICH guidelines and USFDA regulations.
- Knowledge of API regulatory documentation and Drug Master Files.
- Excellent analytical and problem-solving abilities.
- Strong communication, presentation, and coordination skills.
Why Join Fresenius Kabi?
Fresenius Kabi is a globally recognized pharmaceutical and healthcare company known for its commitment to quality, innovation, and patient care.
Benefits of Working at Fresenius Kabi
- Opportunity to work with global regulatory standards.
- Exposure to international pharmaceutical compliance processes.
- Career growth in Regulatory Affairs and API documentation.
- Collaborative and professional work environment.
- Learning opportunities across R&D and regulatory functions.
How to Apply
Interested candidates can share their updated CV at:
Email: sonia.kaushik@ext.fresenius-kabi.com
Subject Line: Pharmabharat Candidate – Application for RS- Regulatory Affairs
Candidates are advised to apply at the earliest as applications are currently being accepted.