Sam Global Biocare Hiring Drug Regulatory Affairs Associate
- Sam Global Biocare Hiring Drug Regulatory Affairs Associate in Gurugram | Pharma Regulatory Jobs
- Company Overview
- Job Role & Responsibilities
- Drug Regulatory Affairs Associate Responsibilities
- Eligibility / Qualifications
- Educational Qualification
- Experience
- Required Skills
- Preferred Skills
- Location & Salary
- Job Location
- Work Mode
- Expected Salary
- Application Process
- Frequently Asked Questions
- Who can apply for the Sam Global Biocare Drug Regulatory Affairs role?
- What experience is required for this regulatory affairs job?
- Which markets are preferred for this role?
- What are the major responsibilities in this DRA role?
- What skills are important for pharmaceutical regulatory affairs jobs?
- Is immediate joining preferred for this vacancy?
Sam Global Biocare Hiring Drug Regulatory Affairs Associate in Gurugram | Pharma Regulatory Jobs
Sam Global Biocare Pvt. Ltd. is hiring for the position of Drug Regulatory Affairs Associate at its Gurugram location. Candidates with experience in pharmaceutical regulatory affairs, CTD dossier preparation, export documentation, international market registrations, and regulatory compliance can apply for this opportunity.
This opening is suitable for pharmaceutical professionals searching for regulatory affairs jobs in Gurugram, pharma dossier preparation careers, CTD documentation roles, export regulatory jobs, and international pharmaceutical compliance opportunities.
The pharmaceutical regulatory affairs sector continues to witness strong hiring demand as Indian pharmaceutical companies expand into regulated and semi-regulated international markets including the Middle East, Africa, and CIS regions. Companies are actively recruiting professionals skilled in regulatory documentation, product registration, dossier management, and global pharmaceutical compliance.
Candidates with expertise in CTD/ACTD dossier preparation, regulatory coordination, pharmaceutical export documentation, and market registration processes will find this opportunity highly relevant.
Company Overview
Sam Global Biocare Pvt. Ltd. is a pharmaceutical company engaged in healthcare product development, regulatory operations, pharmaceutical exports, and international market business coordination. The company supports pharmaceutical product registrations, regulatory compliance, documentation management, and export operations for global markets.
The organization focuses on maintaining pharmaceutical quality standards, regulatory compliance systems, and documentation accuracy while supporting healthcare product registrations across multiple countries.
Sam Global Biocare provides career opportunities for professionals interested in pharmaceutical regulatory affairs, export compliance, dossier preparation, product registration, and international market operations.
Candidates joining the company gain exposure to international pharmaceutical regulations, CTD dossier systems, export-oriented regulatory workflows, packaging compliance, and global documentation standards.
Job Role & Responsibilities
Drug Regulatory Affairs Associate Responsibilities
The selected candidate will support regulatory affairs operations related to pharmaceutical dossier preparation, international market registrations, regulatory documentation, and compliance coordination.
Key responsibilities include:
- Prepare CTD and ACTD dossiers for international pharmaceutical markets
- Review regulatory documents including COPP, FSC, COA, and stability data
- Coordinate with manufacturers regarding regulatory compliance requirements
- Handle dossier review and documentation verification activities
- Support variation filings and product renewal processes
- Respond to regulatory queries from international authorities
- Assist in pharmaceutical product registration activities
- Support packaging and artwork compliance management
- Maintain regulatory documentation and submission records
- Coordinate with cross-functional regulatory and export teams
- Ensure documentation accuracy and regulatory compliance
- Support international pharmaceutical market expansion activities
This role is suitable for candidates searching for:
- Drug Regulatory Affairs jobs in Gurugram
- CTD dossier preparation jobs
- Pharma regulatory affairs associate careers
- Pharmaceutical export documentation jobs
- Regulatory compliance officer roles
- International market registration jobs
- DRA executive jobs in pharma companies
- ACTD dossier preparation careers
- Pharma export regulatory jobs
- Pharmaceutical documentation specialist jobs
Eligibility / Qualifications
Educational Qualification
Candidates with the following educational backgrounds are eligible: B.Pharm, M.Pharm, Pharm.D, MSc Chemistry, MSc Pharmaceutical Chemistry, Biotechnology, Life Sciences, Regulatory Affairs, Pharmaceutical Sciences, and related pharmacy or life science degrees.
Experience
Candidates should have 2 to 3 years of experience in pharmaceutical regulatory affairs, dossier preparation, regulatory documentation, or export regulatory operations.
Required Skills
Applicants should possess:
- Experience in pharmaceutical regulatory affairs operations
- Strong knowledge of CTD and ACTD dossier preparation
- Understanding of regulatory documentation processes
- Experience handling COPP, FSC, COA, and stability documentation
- Knowledge of dossier review, renewals, and variations
- Good communication and coordination skills
- Strong documentation and analytical abilities
- MS Office and MS Excel proficiency
- Attention to detail and compliance management skills
- Ability to coordinate with manufacturers and regulatory stakeholders
Preferred Skills
Candidates with the following experience will have an added advantage:
- Experience in export-oriented pharmaceutical companies
- Exposure to Middle East, Africa, and CIS pharmaceutical markets
- International pharmaceutical registration experience
- Packaging and artwork compliance knowledge
Location & Salary
Job Location
Gurugram
Work Mode
- Full Time
- On-site Role
- Immediate Joining Preferred
Expected Salary
₹4.5 LPA to ₹7 LPA approximately, depending on regulatory affairs experience, CTD dossier exposure, international market knowledge, and interview performance.
Application Process
Interested candidates can share their updated CV through the official email ID mentioned below:
Email: dra@samglobalbiocare.com
Candidates are advised to mention the following details in their CV:
- Individual dossiers prepared
- Countries handled or worked for
Immediate joiners may receive preference during the recruitment process.
Frequently Asked Questions
Who can apply for the Sam Global Biocare Drug Regulatory Affairs role?
Candidates with B.Pharm, M.Pharm, Pharm.D, MSc, Biotechnology, and related pharmacy or life science qualifications can apply.
What experience is required for this regulatory affairs job?
Candidates should have 2 to 3 years of experience in pharmaceutical regulatory affairs, dossier preparation, or regulatory documentation.
Which markets are preferred for this role?
Candidates with exposure to Middle East, Africa, and CIS pharmaceutical markets are preferred.
What are the major responsibilities in this DRA role?
The role includes CTD dossier preparation, regulatory documentation review, product registration support, renewals, and compliance coordination.
What skills are important for pharmaceutical regulatory affairs jobs?
Knowledge of CTD/ACTD dossiers, documentation management, regulatory compliance, MS Office, and communication skills are important.
Is immediate joining preferred for this vacancy?
Yes. Immediate joiners are preferred for this role.
| Company | Sam Global Biocare Pvt. Ltd. |
|---|---|
| Department Vacancies | Drug Regulatory Affairs Associate |
| Qualification | B.Pharm, M.Pharm, Pharm.D, MSc, Biotechnology |
| Experience | 2 to 3 Years |
| Location | Gurugram |
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