📍 Job Location: Vikhroli, Mumbai
🏢 Company: Cipla Limited
🧑💼 Position: RA Specialist – API (Active Pharmaceutical Ingredient)
⏳ Experience: Minimum 3 Years
💼 Employment Type: Full-Time (On-Site)
🎓 Qualification: B.Pharm / M.Pharm / M.Sc
📧 Application Mode: Email Submission
🏢 About Cipla
Cipla is one of India’s most trusted pharmaceutical companies with a legacy of over eight decades in healthcare innovation and patient-centricity. Operating across more than 80 countries, Cipla has a significant presence in therapeutic segments like respiratory, HIV/AIDS, oncology, and complex generics.
The company’s motto, “Caring for Life,” is reflected in its dedication to quality, affordability, and regulatory excellence.
👩⚕️ Role Overview: Regulatory Affairs Specialist – API
This is a golden opportunity for experienced Regulatory Affairs professionals to join Cipla’s API division, focusing on compliance, global filings, and dossier management. Candidates must have in-depth experience with international regulatory agencies such as USFDA, WHO, EMA, and others.
This role is based at Cipla’s Mumbai office (Vikhroli) and offers a dynamic working environment, challenging responsibilities, and collaboration with global pharma experts.
✅ Key Responsibilities
✔ Regulatory Documentation & Filing
- Prepare, review, and file dossiers for APIs to various global regulatory bodies (USFDA, WHO, EMA, ANVISA, etc.)
- Ensure timely and accurate regulatory submissions for product registrations and renewals
✔ CMC (Chemistry, Manufacturing & Controls) Handling
- Collaborate with cross-functional teams to compile and validate technical documents related to API manufacturing, specifications, and process validations
- Ensure all submissions adhere to CMC requirements
✔ Global Regulatory Compliance
- Maintain a thorough knowledge of changing international regulations
- Ensure that all documentation and practices comply with global standards and ICH guidelines
✔ Query Resolution
- Proactively respond to regulatory agency queries in a time-bound and professional manner
- Provide scientific justifications and follow-up data as needed
✔ Technical Support & Coordination
- Work closely with QA/QC, Production, R&D, and Supply Chain teams to ensure end-to-end compliance
- Participate in internal audits and risk assessments to maintain regulatory readiness
🧠 Skills & Qualifications
| Requirement | Details |
|---|---|
| Education | B.Pharm / M.Pharm / MSc (Life Sciences or Chemistry) |
| Experience | Minimum 3 Years in Regulatory Affairs (API domain) |
| Knowledge Base | USFDA, WHO, EMA guidelines; ICH Q-series guidelines |
| Technical Skills | API dossier writing, CTD/eCTD formats, CMC handling |
| Soft Skills | Time management, documentation accuracy, teamwork |
| Location | Vikhroli, Mumbai (On-site role) |
🔍 Desired Candidate Profile
- Deep knowledge of global regulatory submission procedures
- Proficient in technical documentation and cross-functional coordination
- Strong understanding of drug development lifecycle, quality compliance, and market authorization requirements
- Good written and verbal communication skills for inter-departmental and external correspondence
🧬 Ideal Background
Candidates coming from formulation regulatory backgrounds or having experience in biotech/pharma plants are preferred, but this position specifically emphasizes API regulatory documentation.
Experience in handling CEP, DMF, LoA, and ASMF filings will be considered a major advantage.
🎯 Why Choose Cipla?
Cipla isn’t just another pharmaceutical company — it’s a legacy brand that empowers professionals, encourages innovation, and maintains the highest compliance standards.
What You Can Expect:
- 🧠 Exposure to complex API filings and global regulatory bodies
- 🚀 Rapid career growth opportunities in a reputed MNC
- 🤝 Collaboration with top minds in QA, R&D, RA, and production
- 🏥 Employee health benefits, insurance, and learning programs
- 🌍 Global working standards and ethical work culture
📍 Location Details
- 📌 Office: Cipla Limited, Vikhroli, Mumbai
- 🧑💻 Mode of Work: In-office (No remote option)
- 🗓️ Schedule: Full-time, Monday to Friday
📩 How to Apply?
Interested candidates should email their updated CV to the Cipla recruitment team at:
- Email: abhijit.dixit@cipla.com
- Subject Line: “API – RA [Your Name]”
Make sure to include your:
- Contact details
- Updated resume
- Relevant experience in API/Regulatory Affairs
- Notice period & current location
✨ Final Take
If you are a Regulatory Affairs professional with a strong background in APIs and global filings, Cipla is offering you a chance to elevate your pharma career.
This role is tailor-made for those who want to work with international guidelines, handle high-level dossier responsibilities, and contribute to a company that values healthcare innovation and regulatory compliance.
Apply now and become part of Cipla’s journey toward building a healthier tomorrow.
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