Genedrift is hiring for the position of Senior Executive – Regulatory Affairs for its Regulatory Affairs team. The role offers a remote work opportunity in India and involves projects across Biologics, Biosimilars, Injectables, Vaccines, and Medical Devices.
Job Details
| Details | Information |
|---|---|
| Company | Genedrift |
| Position | Senior Executive – Regulatory Affairs |
| Location | India |
| Work Mode | Remote |
| Experience | 2–5 Years |
| Qualification | B.Pharm / M.Pharm |
| Areas | Biologics, Biosimilars, Injectables, Vaccines & Medical Devices |
Position
Senior Executive – Regulatory Affairs
The position is part of Genedrift’s Regulatory Affairs team and involves working on projects across biologics, biosimilars, injectables, vaccines, and medical devices.
Responsibilities
The role requires expertise in:
- CTD/ACTD dossiers
- Health Authority (HA) submissions
- Regulatory coordination
- Compliance documentation
Eligibility / Qualifications
Candidates should meet the following criteria:
- B.Pharm or M.Pharm
- 2–5 years of experience
- Expertise in CTD/ACTD dossiers, HA submissions, regulatory coordination, and compliance documentation
Required Skills
Relevant expertise includes:
- CTD/ACTD dossier preparation
- Health Authority submissions
- Regulatory coordination
- Compliance documentation