Cipla, as an organisation has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.
Post : Team Member - Regulatory Affairs (91953)
Job Description
Job Purpose
1. Coordination for dossier checklist, preparation and submission, follow-up for timely regulatory approval and response submission.
2. Participate in discussions and coordinate with RA/IPD/Portfolio/Medical Affairs/Marketing team to obtain all the necessary documentation specific to products in compliance to regulatory requirement.
• Product approval status for registration in India
• Identify and track the status of a product approval in India (DCGI approval) and globally.
• Track CDSCO banned list of products and its impact on our brands
• Track various approval checklists
• Collaborate effectively with internal stakeholders on regular basis
• Actively participate in regular discussions and planning with cross functional teams (RA/ Portfolio/ Medical/ Clinical/ R&D/ FDA licensing Teams) and provide insight to ensure regulatory timelines are met or improved.
• Drive towards full compliance with regulatory requirements for India.
• DTAB/ DCC/ SEC meetings
• Track DTAB/DCC/SEC/other relevant stakeholder meetings and share intelligence related to our projects/ company.
• Prepare MOM summary of key meetings and projects relevant to Cipla
• Preparation of regulatory monitor and market intelligence data
• Analyse and share market intelligence data and preparation of regulatory monitor capturing key regulatory developments on monthly basis.
• Actively co-ordinating with internal stakeholders for preparation of regulatory dossier as per DCGI requirement and follow up for its submission.
• Ensure the reduction of repeated queries and reduce timelines for approvals
Candidate Profile
• B.Pharm / M.Pharm / other regulatory certified courses will be preferred
• Minimum 5-10 years of experience in Regulatory Affairs
Additional Information
Experience : 5-10 years
Qualification : B.Pharm / M.Pharm
Location : Maharashtra - Vikhroli
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 28th February 2025
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