Sam Global Biocare Private Limited is hiring experienced professionals for the position of Drug Regulatory Affairs Associate at its Gurugram location. This is an excellent opportunity for candidates with 2–3 years of pharmaceutical regulatory affairs experience, especially those with expertise in CTD/ACTD dossier preparation, international market submissions, and regulatory documentation.
Candidates with exposure to export-oriented pharmaceutical companies and regulatory markets such as the Middle East, Africa, and CIS regions will have an added advantage. If you are looking for Regulatory Affairs jobs in Gurugram, Pharma Dossier Preparation jobs, or International Regulatory Affairs opportunities in India, this opening could be ideal for your career growth.
Author: pharmabharat editorial team
Job Highlights
| Particulars | Details |
|---|---|
| Job Title | Drug Regulatory Affairs Associate |
| Company | Sam Global Biocare Private Limited |
| Location | Gurugram, Haryana |
| Job Type | Full-Time |
| Experience Required | 2–3 Years |
| Industry | Pharmaceuticals |
| Department | Regulatory Affairs |
| Mode of Work | On-site |
Key Responsibilities
The selected candidate will be responsible for:
- Preparing CTD and ACTD dossiers for international pharmaceutical markets
- Reviewing regulatory documents such as COPP, FSC, COA, and stability data
- Coordinating with manufacturers to ensure regulatory compliance
- Managing dossier reviews, renewals, variations, and query responses
- Supporting product registration activities
- Ensuring packaging and artwork compliance as per regulatory guidelines
- Maintaining proper documentation and submission timelines
Required Qualifications
Candidates applying for this Pharma Regulatory Affairs job should possess:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline
- 2–3 years of experience in pharmaceutical regulatory affairs
- Strong understanding of CTD/ACTD dossier preparation
- Good communication and coordination skills
- Proficiency in MS Excel and MS Office
- Strong attention to detail and documentation accuracy
Preferred Skills
Preference will be given to candidates with:
- Experience in export-oriented pharmaceutical companies
- Exposure to Middle East, Africa, or CIS regulatory markets
- Knowledge of international regulatory submission requirements
- Experience handling regulatory queries and renewals
Why Join Sam Global Biocare?
- Opportunity to work on international pharmaceutical markets
- Exposure to global regulatory documentation processes
- Career growth in pharmaceutical regulatory affairs
- Collaborative and professional work environment
- Hands-on experience in dossier preparation and compliance activities
Important Instructions for Applicants
Candidates are requested to clearly mention the following details in their CV:
- Individual dossiers prepared
- Countries worked for
- Experience in international regulatory submissions
How to Apply
Interested and eligible candidates can send their updated CV to:
📩 Email: dra@samglobalbiocare.com