Jr. Team Member Ra

**Division**:
**Department**:
**Sub Department 1**:
**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 (1/6)**:
**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 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

**Key Accountabilities (2/6)**:
**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**
- 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/)

**Key Accountabilities (3/6)**:
**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
- 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

**Key Accountabilities (4/6)**:
**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

**Key Accountabilities (5/6)**:

- 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 (F