Regulatory & Pricing Coordination | Corporate Affairs- Cipla

1. Job Purpose:

1. Regulatory dossier review, submission and follow-up for timely approval and response submission.

2. Participate in discussions and coordinate with RA/IPD/Portfolio/Medical Affairs/Marketing team to obtain all the necessary documentation specific to products in compliance to regulatory requirement.

3. Follow up with DCGI/ CDSCO office, IPC among others.

2. Accountabilities:

1. Dossier review, submission and approval for regulatory approvals (Marketing Authorisation/ Registration-IND, New Drugs, Subsequent New Drugs, Biologicals & Registration for import & IPC testing, BE NOC )

• Active co-ordination with internal stakeholders for submission of regulatory dossier as per DCGI requirement.
• Check preparation of quality regulatory dossier as per the respective checklists of documents and ensure their timely submission to the regulatory authority.
• Submission of samples for testing and analysis at IPC labs .
• Prioritizing the project and follow-up with internal stakeholder for early submission and approval of new launches.
• Follow up at DCGI / CSDCO office to obtain on-time/ expedited approvals.

2. Collaborate effectively with internal stakeholders on regular basis

• Meeting/ exceeding approval timelines in accordance with Regulatory master plan.
• Zero Deficiency Submissions, to ensure the reduction of repeated queries and clearance of files smoothly.
• Track DTAB/DCC/SEC/other relevant stakeholder meetings and share intelligence related to our projects/ company.

3. NPPA Pricing approvals and closure of notices

• Timely submission of appropriate response and follow up at NPPA and FDA and ensure notice closure.
• Follow-up and ensure price approval of new drug, special price approvals at NPPA related to Cipla products.

4. Relationship building with external stakeholders

• Establish a knowledge-based and credible relationship with key regulatory personnel through regular interactions and technical discussion.(CDSCO DCGI office/ NPPA)
• Communicate & network with regulatory agencies for getting better clarity on current regulatory requirements and preparation of responses.
• Participate in the technical meetings with the subject experts.