Team Member - Regional RA

Division

Department

Sub Department 1

Job Purpose

Submit 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-cycle

Key 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/Month

Submission of DMFs to authorities: Approx. 14/Month

Submission of AP DMFs to customer: Approx. 12/Month

Legalization of documents: Approx. 20 documents /Month

Dimensions (2/2)

Key Decisions (1/2)

Classification and type of change category for moderate and major changes confirm with group leader

Key Decisions (2/2)

Education Qualification

B.Pharmacy, M. Pharm, Bsc or MSc

Relevant Work Experience

Minimum 5 years’ experience in regulatory activity in pharma industry preferably worked for same region/authority.  Hands-on experience of eCTD submission