Team Member - Regional RA

India
Permanent
Full-time

10 days ago

DivisionDepartmentSub Department 1Job PurposeSubmit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycleKey Accountabilities (1/6)Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, 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
*Create DMF master in LoA software & issue LoAs/CEPs
Verify pre-approved documents
Leverage product gap analysis
#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

Key Accountabilities (2/6)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

Key Accountabilities (3/6)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

Review DMF and resolve discrepancies (if any) in co-ordination with CFTs
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.

*Attend launch meetings with internal and external stake-holders
*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

Key Accountabilities (4/6)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

Provide the information on the suitability and availability of dossier for out-licensing and in-licensing

Check the dossier information for due-diligence
Perform drug listing and review labelling

Key Accountabilities (5/6)Check with regulatory authorities (EU, NZ & TGA) for submission activity and approval status for submission done

Check with authorities for safe receipt of submitted DMF/documents as and when required
Communicate to authorities for regulatory support/data requirement to get approvals
Maintaining the acknowledgement letters/deficiency letters received from Regulatory Health Agency

Key Accountabilities (6/6)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

Key Interactions (1/2)

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

Key Interactions (2/2)

Customers - product related queries / additional information required by customers and status updates- (daily)
Regulatory consultants - submissions, queries, status (weekly)
Software provider - trouble shooting (need basis)
Health authorities- follow up- seek advice (need basis)

Dimensions (1/2)Issuance of LoAs/CEPs: Approx. 100/MonthSubmission of DMFs to authorities: Approx. 14/MonthSubmission of AP DMFs to customer: Approx. 12/MonthLegalization of documents: Approx. 20 documents /MonthDimensions (2/2)Key Decisions (1/2)Classification and type of change category for moderate and major changes confirm with group leaderKey Decisions (2/2)Education QualificationB.Pharmacy, M. Pharm, Bsc or MScRelevant Work ExperienceMinimum 5 years' experience in regulatory activity in pharma industry preferably worked for same region/authority. Hands-on experience of eCTD submission

Cipla

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