Cipla Hiring Regional Regulatory Affairs (RA) Team Member

M.Pharm, B.Pharm, B.Sc/M.Sc Jobs in Regulatory Affairs – Cipla Hiring in Vikhroli (5+ Years Exp.)

Apply for Cipla’s Regulatory Affairs job in Vikhroli. B.Pharm, M.Pharm, B.Sc or M.Sc 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, B.Sc, or M.Sc 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

• Compile and submit dossiers, DMFs, and deficiency responses per region-specific regulatory guidelines.

• Collaborate with cross-functional teams to ensure timely responses to queries.

• Create and manage DMF masters and Letters of Access (LoAs).

Post-Approval Activities

• Submit variations to improve productivity, compliance, and cost-effectiveness.

• Coordinate for product renewals, labelling updates, and drug listings.

• Maintain SPL documentation and perform sunset clause filings.

Dossier & Document Management

• Ensure dossiers are updated with internal changes and evolving regulatory guidelines.

• Track product registration data via PRC/SAP-RA databases.

• Maintain acknowledgment and deficiency letters from regulatory health agencies.

Stakeholder Coordination

• Liaise with internal teams like R&D, QA/QC, production, packaging, supply chain, PV, and patent divisions.

• Interface with regulatory authorities (EU, NZ, TGA) for submission status and queries.

• Maintain contact with software providers and consultants for troubleshooting and document management.

Skills and Qualifications

Minimum Education Required:

• B.Pharm / M.Pharm

• B.Sc / M.Sc in a relevant life science discipline

Experience:

• Minimum 5 years in Regulatory Affairs

• Hands-on experience with eCTD submission

• Exposure to dossier compilation, post-approval maintenance, and regulatory audits

Preferred Skills:

• Excellent documentation and technical writing skills

• Familiarity with regulatory databases and tracking tools

• Strong communication for cross-functional coordination

• 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.

🔗 Apply Now

📍Location: Vikhroli, Maharashtra
📅 Posting Date: July 17, 2025
📨 For internal referrals or inquiries, visit the Cipla career portal.

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