Associate Manager / Manager - Medical Affairs

Role & responsibilities

Regulatory

1. Ensure preparation, review, compilation and submission of regulatory dossiers (API & FDF), resolve agency queries and obtaining approvals on time for domestic market (CDSCO)

2. SPOC for routing all the regulatory queries, requires interaction with CFTs (mainly R&D, QA, BD) and regulatory consultant to facilitate adequate response within the time frame for all the regulatory queries raised.

3. Documents for filing, querys response submission to CDSCO shall be reviewed with regulatory consultant (product basis) & internal team before submission in portal & subsequently track approval timelines

4. Attending SEC meetings of CDSCO along with CRO & regulatory consultant to obtain BENOC/CTNOC/ Waiver for applications, review SEC presentations.

5. Coordinating submission of IPC samples, documents to IP commission and follow-up for IPC test report.

6. Providing regulatory information updates, new product updates to team &BD

7. Devising product strategy to support the business development Team

8. Maintaining regulatory databases and tracking key documents for easy retrieval and reference.

9. Taking budget approvals from management before initiating filing or any activity which requires payments & subsequently manage invoices

10. Travel to CDSCO office, Delhi to follow-up on applications submitted in CDSCO as and when required (once in 45-60 days) & and establishing effective relationships with regulatory authorities & taking appoinments if required

Medical

1. Responsible for submission of clinical trial /BE applications to agency

2. Selection of CRO (BE/CT/Animal toxicology) study center, negotiation with CRO for quotations along with SCM team and finalize CRO for study

3. Responsible for review of BE/CT/Animal toxicology study protocols for submission in CDSCO

4. Preparation of BENOC/BE waiver/CTNOC/CT waiver presentations for SEC meetings.

5. CTRI registration, IP&RLD management, CDSCO query handling

6. Follow-up with CRO from start to end of the CT to ensure smooth execution in terms of quality, cost and timelines

7. Updating study status to team, Onsite/remote site monitoring of studies as per regulations, AE reporting, Handling of audits (if any), review of the CSR, submission of final CSR

8. Communicating with CDSCO regarding the progress of studies (if required) to ensure compliance with regulations Submission of pre & post study documents,

9. Preparation of clinical, non-clinical dossier, leaflets, SMPC for the submission,

10. Preparation of scientific medico-marketing initiatives such as new product slides to circulate to customers. (if required)

11. Scientific Literature search - Collating relevant medical information and analysing it for medico -marketing value, handling queries about the products & related diseases (if required)