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