Drug Regulatory Affairs Executive opening at Sam Global Biocare

Sam Global Biocare Hiring Drug Regulatory Affairs Executive in Gurugram: 2–3 Years Experience, Immediate Joining Preferred

Sam Global Biocare Private Limited is hiring a Drug Regulatory Affairs Executive for its Gurugram office, targeting candidates with 2 to 3 years of experience in dossier preparation, regulatory documentation, and international market coordination. The company has flagged this as an immediate-joining opportunity, making it relevant for regulatory affairs professionals who are actively searching for pharma jobs in Gurugram and ready to step into an on-site role quickly. The position centres around preparing and managing regulatory dossiers for export markets, making it a strong fit for candidates with prior exposure to international product registrations.

Company Overview

Sam Global Biocare Pvt. Ltd. is an India-based pharmaceutical export company focused on registering and supplying finished formulations across global healthcare markets, with a particular emphasis on the Middle East and Africa. The company offers a wide portfolio of pharmaceutical products spanning therapeutic categories such as cardiovascular, anti-diabetic, respiratory, gastrointestinal, pain management, neurology, dermatology, oncology, and HIV and antiviral therapies, among others. All products are sourced from EU-GMP and WHO-GMP certified manufacturers, reflecting the company’s emphasis on quality, safety, and regulatory compliance as it expands its presence across international markets. For regulatory affairs professionals, this gives direct exposure to cross-border product registration work rather than a purely domestic regulatory function.

Job Role & Responsibilities

The Drug Regulatory Affairs Executive will be responsible for preparing CTD and ACTD dossiers for international markets, a core requirement for registering pharmaceutical products in countries with varying regulatory frameworks. The role also involves reviewing key regulatory documents such as Certificates of Pharmaceutical Product (COPP), Free Sale Certificates (FSC), Certificates of Analysis (COA), and stability data, ensuring all documentation aligns with target market requirements. Coordination with manufacturers to maintain regulatory compliance is a continuous part of the role, alongside handling dossier reviews, variations, renewals, and responses to regulatory queries raised by health authorities. The position also includes supporting product registration processes and ensuring packaging and artwork compliance across the markets the company serves.

Eligibility & Qualifications

While Sam Global Biocare has not specified a fixed degree requirement in this posting, candidates for regulatory affairs roles in the pharmaceutical export industry typically hold a B.Pharm, M.Pharm, or M.Sc. in a relevant life sciences discipline. Beyond academic qualifications, the company is looking for the following:

• 2 to 3 years of hands-on experience in pharma regulatory affairs, ideally including dossier preparation work
• Strong working knowledge of CTD and ACTD dossier formats and requirements
• Good documentation skills and the ability to coordinate effectively with manufacturers and internal teams
• Proficiency in MS Excel and MS Office for managing regulatory data and reports
• Strong attention to detail and clear communication skills, given the precision required in regulatory submissions

Candidates with prior experience at export-oriented pharmaceutical companies, particularly those who have worked on registrations for the Middle East, Africa, or CIS markets, will be given preference. Applicants are also advised to clearly mention the number of individual dossiers they have prepared and the countries they have worked for directly in their CV.

Location & Salary

This is an on-site position based in Gurugram, Haryana. Sam Global Biocare has not disclosed a specific salary figure for this role. Based on prevailing compensation trends for Drug Regulatory Affairs Executives with 2 to 3 years of experience in export-focused pharmaceutical companies in the Delhi NCR region, candidates can expect an estimated annual package in the range of ₹4 LPA to ₹7 LPA, depending on prior dossier experience and exposure to international markets.

Application Process

Interested candidates can apply by sharing their CV directly over email or by messaging the company’s recruitment contact on LinkedIn.

• Email your CV to: dra@samglobalbiocare.com
• Alternatively, you can reach out via direct message on LinkedIn
• Be sure to mention the number of individual dossiers you have prepared and the specific countries you have worked for, as the company has explicitly asked for this information to be included in your CV

Frequently Asked Questions

What experience is required for this role? Candidates need 2 to 3 years of experience in pharma regulatory affairs, particularly in dossier preparation, regulatory documentation, and international market coordination.

Is prior export market experience necessary? It is not strictly mandatory, but candidates with experience at export-oriented pharma companies, especially with exposure to Middle East, Africa, or CIS markets, will be preferred.

Where is this job located? This is an on-site role based in Gurugram, Haryana.

How do I apply for this position? You can apply by emailing your CV to dra@samglobalbiocare.com or by reaching out directly through LinkedIn. Be sure to mention your dossier preparation experience and the countries you have worked for.

What is the expected salary for this role? Sam Global Biocare has not disclosed a specific figure. Based on industry trends for similar roles, the estimated range is approximately ₹4 LPA to ₹7 LPA.

Tagged as: Pharma Jobs in Gurgaon