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 : Jr. Team Member RA
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.
Job Description
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
• Co-ordinate with cross-functional teams and external stake-holders for query response discussion and distribute updated work plan
• Assist in verifying pre-approved documents
• Assist in preparing compilation and submission of the dossier documents / deficiency responses to agency as per the region specific requirements(for Para-IV -US)
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
• Assist in verifying pre-approved documents/variation packages as received from LCM.
• Assist in prepare labelling submission package to be in-line with RLD labelling updates and submit to the authority
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
• Assist in reviewing DMF and resolve discrepancies (if any) in co-ordination with CFTs
• Assist in evaluation of proposals related to changes (Facility change con/Notifications) and conveying line of action to manufacturing unit/relevant stakeholders
Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database
• Support in updating tracker for DMF number assigned by Regulatory Health Agencies and maintain the relevant data base (LOA software) upto date
• Include and update registration details in databases (PRC/SAP-RA table/)
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
• Co-ordinate within cross functional teams for information and data required for submission
• Assist in planning the compilation of DMF
• Support in reviewing documents, compilation and filing of dossiers with no transcription errors
• Support in reviewing deficiency database before compilation to avoid repetition of deficiencies
Support in performing the gap assessment to leverage the application to different market
• Co-ordinate within cross functional teams to collate information/data.
• Assist in creating database for product under evaluation
• Support in planning and Compiling the document package as per the update and current guidance requirement
Adopt and disseminate information on new regulatory guidelines through ongoing training and interaction with regional teams to minimize deficiencies
• Gather knowledge about country specific requirements of projects undertaken by attending training session on SOPs and guidelines, self-learning from regulatory guidance
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
• Support in verify pre-approved documents
• Preparation compilation and submission of the dossier documents / deficiency responses to agency as per the region specific requirements(for Para-IV -US)
• Preparation of M1 documents, and collate the dossier/ deficiency responses package/DMF received from CDT and submit to the regulatory authority/customer
• Submit online audit dossier/DMF along with queries
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.
• Verify pre-approved documents/variation packages as received from LCM
• Prepare M1 documents, and collate variation packages and annual report packages received from LCM team and submit to the regulatory authority/customer
• Check for the MA business interest from stakeholders and progress with the renewal/ sunset clause filing
• Prepare labelling submission package to be in-line with RLD labelling updates and submit to the authority
• Prepare SPL and Drug listing for customer/launch products
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
Evaluate proposals related to changes (Facility change con/Notifications) and conveying line of action to manufacturing unit/relevant stakeholders.
Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database
• *Updating tracker for DMF number assigned by Regulatory Health Agencies and maintain the relevant data base (LOA software) upto date
• Notify cross-functional teams and external stake-holders about the approvals and approved documents
• Include and update registration details in databases (PRC/SAP-RA table/)
• # Provide details for APQR compilation
Provide Regulatory support throughout the life cycle of the product for smooth functioning
• Provide the approved product information (labelling) and the relevant documents as requested by the drug safety or quality teams
• Confirm product list and MA details for finalization of TA
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
Candidate Profile
B.Pharmacy, M. Pharm, Bsc or MSc
0-1 year experience in regulatory team will be favorable
Additional Information
Experience : 0-1 year
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Maharashtra - Vikhroli
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : RA
End Date : 31st May 2024
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