Sun Pharma M Pharm Regulatory Affairs Job | Biologics

Sun Pharma Hiring Senior Executive in Regulatory Affairs – Biologics | Apply Now for Gurugram, Mumbai, or Vadodara

Explore an exciting opportunity at Sun Pharmaceutical Industries Ltd for the role of Senior Executive – Regulatory Affairs (Biologics). Ideal for candidates with experience in regulatory operations, biologics, and market extension filings, this opening is available at multiple locations including Gurgaon (R&D), Mumbai, and Vadodara.

Career Opportunity: Regulatory Affairs in Biologics at Sun Pharma

Sun Pharma, one of India’s largest and most respected pharmaceutical companies, is inviting experienced professionals to join its regulatory team. This position offers the chance to contribute to the development and global approval of life-saving biologic medicines.

Key Responsibilities

► Regulatory Strategy and Submissions

• Support compilation and submission of MAA, LCM, and post-approval changes.
• Contribute to global submission preparation and lifecycle maintenance.
• Manage market extension filings and address post-approval regulatory requirements.

► Compliance and Documentation

• Perform gap analysis for biologics registration across emerging markets.
• Review Marketing Authorization Applications (MAAs) and variation filings.
• Establish and track effective change controls.
• Develop and update SOPs and Work Instructions aligned with regulatory guidelines.

► Technical and Cross-Functional Collaboration

• Work closely with cross-functional teams to understand technical aspects of biologics.
• Ensure submissions meet local and international regulatory compliance standards.
• Liaise with internal stakeholders and regulatory bodies for timely approvals.

Candidate Profile

Educational Qualification:

• Postgraduate in Pharmacy, Biotech, or relevant Life Sciences field.

Experience Required:

• 4 to 6 years of hands-on experience in Regulatory Affairs of Biologics.

Key Skills:

• Strong knowledge of BLA, NDA, MAA filing, and post-approval submissions.
• Sound understanding of ICH and regional regulatory trends.
• Independent working ability and clear communication.
• Familiarity with regulatory software/tools is a plus.

Location Preferences

• Gurgaon (R&D)
• Mumbai
• Vadodara

Candidates can express their preference; the company is open to all three locations.

How to Apply

Apply through the official Sun Pharma careers portal: 👉 Apply Here

For best consideration, submit your resume with updated project experience and regulatory achievements.

Quick Overview Table

Company Name	Sun Pharmaceutical Industries Ltd
Vacancy Department	Regulatory Affairs – Biologics
Required Education	M.Pharm, M.Sc in Life Sciences
Experience Required	4 to 6 Years
Job Location	Gurgaon, Mumbai, Vadodara (Any Preferred)

M.Pharm/M.Sc job opening at Sun Pharma for Regulatory Affairs Biologics in Gurgaon, Mumbai, or Vadodara. Apply now if you have 4+ years of RA experience.