Cipla Ltd is hiring B. Pharma/ M. Pharma/ B. Sc/ M. Sc freshers as a Junior Team Member Regulatory Affairs – Apply Now

Exciting news for aspiring pharmaceutical professionals! Cipla Ltd is on the lookout for dynamic B.Pharmacy, M. Pharm, B. Sc or M. Sc graduates to join as Junior Team Member Regulatory Affairs for the Vikhroli Region. If you’re passionate about ensuring quality in pharmaceutical products and eager to grow in a renowned organization like Cipla, this opportunity is for you. Don’t miss your chance to kickstart a rewarding career journey with a global leader in healthcare. Learn more about how you can become a part of our dedicated team!

Job Purpose

• Regional: Assist in submission of product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and support in handling post-approval changes, maintenance, and updation of documents during the products life-cycle.
• CDT: Assist in compiling dossier in accordance with regulatory strategy, manage deficiencies, evaluate products and submit tenders to ensure adherence to regulatory requirement for various regulated/international markets within agreed timelines.
• LCM: Support in implement Life cycle management activities for Respi/Non-respi products (for US, EU, South Africa, ANZ, WHO, PEPFAR & 150+ countries ) to have business continuity.

Key Accountabilities

• Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by collation, and compiling documents in order to ensure approvals for launch in stipulated time
• Assist in submission of post approval variations for changes that improves productivity, cost-effectiveness, quality of the product by assisting in reviewing, collating, compiling the variation application to meet the delivery within timelines.
• Maintain, and update product dossier as required to meet changes in Cipla’s internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements.
• Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database.
• Assist in reviewing documents and compile and handover quality dossier as per enforcement of/updates in regulatory guidelines for various regulated/ international market, so as to minimize deficiencies from the health authority.
• Support in performing the gap assessment to leverage the application to different market.
• Adopt and disseminate information on new regulatory guidelines through ongoing training and interaction with regional teams to minimize deficiencies.
• Support in achieving timely submission of dossier/DMF and deficiency responses to regulatory authority by assisting in reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time.
• Submit post approval variations for changes that improves productivity, cost-effectiveness, quality of the product by reviewing, collating, compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization, Renewals/Sunset clause to ensure continuous validity of marketing authorisations.
• Maintain, and update product dossier as required to meet changes in Cipla’s internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements.
• Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database.
• Provide Regulatory support throughout the life cycle of the product for smooth functioning.

Major Challenges

• Delay in the availability of the documents from cross functional teams – leads to inadherence to target deadlines
• Changing regulatory environment, constant updates in the regulations-leads to rework and inadherence to target deadlines
• Change proposals affecting dossier sections leads to leads to rework and inadherence to target deadlines
• Inefficient software-leads to inadherence to target deadlines
• Non adherence to committed timelines by cross functional team effects the overall submission timelines and quality of the dossiers
• Changing strategy from CFT, resulting in changing the plan and re-evaluating the new proposal.
• Technical errors in the executed documents effects their timely submissions
• Change in regulatory environment, which leads to rework due to change in regulatory strategy
• Change in filing strategies which leads to sudden prioritisation and de-prioritisation of project
• Inadequate documentation to evaluate change request, variations causing rework.
• Overcome by preparing a checklist document of necessary documentation to be shared with whosesoever raises the CR

Key Interactions

• RnD team (for formulation clarity-need basis)
• Manufacturing Unit-QA/QC/Production for documents procurement -daily
• Packaging Team (for procurement labeling documents – daily)
• CPM, BD & Supply chain – for routine commercial/launch clarity (weekly basis)
• PV – for product approval notification and audit support (daily)
• Patent Team –to get clarity on product patent and exclusivity (need basis)

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