Cadila Pharmaceuticals Limited has announced an excellent career opportunity for experienced pharmaceutical professionals in the Regulatory Affairs department. The company is inviting applications for the position of Executive – Regulatory Affairs (USA Injectables) at its Dholka location. Candidates with relevant experience in USA Injectable Regulatory Affairs can apply through email.

If you are looking for a rewarding career in one of India’s leading pharmaceutical companies, this opportunity offers a competitive salary package and the chance to work on global regulatory submissions.

Job Overview

Company Name: Cadila Pharmaceuticals Limited

Position: Executive – Regulatory Affairs (USA Injectables)

Department: Regulatory Affairs (Injectables)

Job Location: Dholka, Gujarat, India

Regulatory Market: USA

Experience Required: 4+ Years

CTC: Up to ₹6.90 LPA

Employment Type: Full-Time

Key Responsibilities

The selected candidate will be responsible for:

• Compilation, review and submission of registration dossiers for Injectable dosage forms in the USA.
• Handling regulatory queries and deficiency responses related to injectable products.
• Preparation and submission of supplements, amendments and variations.
• Reviewing functional documents including specifications, test procedures, product development reports, stability protocols, process validation protocols, media fill validation, sterility-related documents, and Change Controls & Deviations.
• Keeping updated with current US FDA, ICH and other applicable regulatory guidelines.
• Creating and maintaining Regulatory Databases for submissions.
• Coordinating with internal departments to ensure timely submissions and query responses.
• Working closely with R&D, QA, QC, Manufacturing and Supply Chain teams for regulatory compliance.

Required Qualifications

Candidates should possess relevant educational qualifications in Pharmacy or Life Sciences suitable for Regulatory Affairs roles.

Preferred Qualification:

• B.Pharm
• M.Pharm
• M.Sc. (Relevant Life Sciences)

Experience Required

• Minimum 4+ years of experience in Regulatory Affairs.
• Hands-on experience in USA Injectable Regulatory Affairs is required.

Salary & Benefits

• CTC: Up to ₹6.90 LPA
• Opportunity to work with a reputed pharmaceutical organization.
• Exposure to international regulatory submissions.
• Professional growth in USA regulatory operations.
• Collaborative and quality-driven work environment.

How to Apply

Interested and eligible candidates can send their updated resume to:

Email: ayushi.rana@cadilapharma.com

Candidates are advised to mention the position name in the email subject while applying.