Cipla Hiring Regional Regulatory Affairs (RA) Team Member
- Join Cipla as Team Member – Regional Regulatory Affairs (RA) in Vikhroli
- About Cipla
- Key Responsibilities in the Role
- Skills and Qualifications
- Location & Work Culture
- Call to Action
- Quick Job Overview Table
M.Pharm, B Pharm, BSc/MSc Jobs in Regulatory Affairs – Cipla Hiring in Vikhroli (5+ Years Exp.)
Apply for Cipla’s Regulatory Affairs job in Vikhroli. B Pharm, M.Pharm, BSc or MSc with 5+ years’ experience in eCTD submission eligible. Multiple dossier/DMF tasks.
Join Cipla as Team Member – Regional Regulatory Affairs (RA) in Vikhroli
Are you an experienced Regulatory Affairs professional looking for a career in one of India’s top pharmaceutical companies? Cipla is inviting skilled candidates to join its Regulatory Affairs (RA) team at its Vikhroli, Maharashtra location. This is a full-time role for professionals with expertise in dossier submission, DMF compilation, and post-approval regulatory updates.
This position is ideal for candidates with M.Pharm, B Pharm, BSc, or MSc qualifications and a minimum of 5 years of experience in eCTD submission and related RA activities.
About Cipla
Cipla is a globally recognized pharmaceutical leader known for its robust portfolio across major therapeutic areas. Committed to “Caring for Life,” Cipla has transformed healthcare through high-quality generics and research-driven drug development. This role at Cipla offers professionals a chance to work in a regulatory-rich environment, interacting with health authorities, consultants, and cross-functional teams.
Key Responsibilities in the Role
Submission & Lifecycle Management
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Compile and submit dossiers, DMFs, and deficiency responses per region-specific regulatory guidelines.
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Collaborate with cross-functional teams to ensure timely responses to queries.
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Create and manage DMF masters and Letters of Access (LoAs).
Post-Approval Activities
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Submit variations to improve productivity, compliance, and cost-effectiveness.
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Coordinate for product renewals, labelling updates, and drug listings.
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Maintain SPL documentation and perform sunset clause filings.
Dossier & Document Management
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Ensure dossiers are updated with internal changes and evolving regulatory guidelines.
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Track product registration data via PRC/SAP-RA databases.
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Maintain acknowledgment and deficiency letters from regulatory health agencies.
Stakeholder Coordination
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Liaise with internal teams like R&D, QA/QC, production, packaging, supply chain, PV, and patent divisions.
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Interface with regulatory authorities (EU, NZ, TGA) for submission status and queries.
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Maintain contact with software providers and consultants for troubleshooting and document management.
Skills and Qualifications
Minimum Education Required:
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B Pharm / M.Pharm
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BSc / MSc in a relevant life science discipline
Experience:
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Minimum 5 years in Regulatory Affairs
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Hands-on experience with eCTD submission
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Exposure to dossier compilation, post-approval maintenance, and regulatory audits
Preferred Skills:
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Excellent documentation and technical writing skills
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Familiarity with regulatory databases and tracking tools
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Strong communication for cross-functional coordination
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Knowledge of Para IV submissions and SPL labelling is a plus
Location & Work Culture
Location:
Cipla, Vikhroli, Maharashtra, India
Call to Action
If you meet the criteria and are passionate about contributing to global regulatory compliance, don’t miss this opportunity at Cipla.
📍Location: Vikhroli, Maharashtra
📨 For internal referrals or inquiries, visit the Cipla career portal.
Quick Job Overview Table
| Company Name | Current Vacancies |
|---|---|
| Cipla Ltd. | Regulatory Affairs |
| Required Education | Experience Required |
|---|---|
| B Pharm, M.Pharm, BSc, MSc | Minimum 5 years in RA |
To apply for this job please visit careers.cipla.com.
