PIL Hiring India Regulatory Affairs (DRA)

Explore the latest Regulatory Affairs Executive job opening at PIL India for B.Pharm/M.Pharm graduates with 4–5 years of experience. Location: India. Apply now!

Regulatory Affairs Executive Job for B.Pharm/M.Pharm with 4-5 Years Experience | PIL India

Exciting Opportunity for Regulatory Affairs Professionals at PIL India

Are you a seasoned Regulatory Affairs expert with 4–5 years of experience and a background in B.Pharm or M.Pharm? PIL India invites applications for the position of Executive – Drug Regulatory Affairs (DRA). This full-time opportunity is ideal for professionals looking to contribute to global pharmaceutical registration and regulatory operations.

About PIL India

PIL India is a trusted pharmaceutical company known for its commitment to quality, compliance, and innovation. With a presence in multiple international markets, PIL continues to expand its global regulatory footprint.

Position Overview: Executive – Drug Regulatory Affairs

This role focuses on supporting regulatory submissions, lifecycle management of registered products, and ensuring documentation compliance for ROW markets.

Key Responsibilities

• Global registration of pharmaceutical products.
• Lifecycle management and post-approval updates for existing products.
• Compilation and continuous update of dossiers for Rest of World (ROW) markets.
• Coordination and review of CMC (Chemistry, Manufacturing, and Controls) data.
• Preparation of variation application documents.
• Collaboration with cross-functional departments for data and sample collection.
• Drafting product questionnaires, SMPCs, PILs, and artwork in line with country-specific guidelines.
• Monitoring regulatory updates and implementing changes accordingly.
• Submitting applications for legal documents like CoPP, FSC, Product Approvals, and WHO GMP certifications.
• Maintaining a robust regulatory database for real-time tracking and planning.

Qualifications and Experience

• Education: B.Pharm or M.Pharm (preferred in Pharmaceutical Sciences).
• Experience: 4–5 years in Regulatory Affairs with exposure to international markets.
• Skills: Excellent communication, knowledge of regulatory guidelines (WHO, EU, USFDA, etc.), CMC documentation, and regulatory databases.

Location

India (Exact location to be confirmed based on final selection)

How to Apply

Interested candidates are requested to email their updated CVs to regulatory@pilindia.in with subject line “Application for Executive – DRA.”

Courses Relevant to B.Pharm/M.Pharm
Pharmaceutical Sciences, Pharmaceutical Chemistry, Pharmaceutics, Pharmacology, Regulatory Affairs, Drug Development, Clinical Pharmacy, and Pharmaceutical Biotechnology

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