Team Member

1 week ago

Vikhroli Mumbai Maharashtra, India Cipla Full time

**Division**:

- Corporate Affairs

**Department**:

- Corporate

**Sub Department 1**:
**Job Purpose**:

- Coordination for dossier checklist, preparation and submission, follow-up for timely regulatory approval and response submission.
- 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.

**Key Accountabilities (1/6)**:
**Product approval status for registration in India**
- Identify and track the status of a product approval in India (DCGI approval) and globally.
- Track CDSCO banned list of products and its impact on our brands
- Track various approval checklists

**Key Accountabilities (2/6)**:
**Collaborate effectively with internal stakeholders on regular basis**
- Actively participate in regular discussions and planning with cross functional teams (RA/ Portfolio/ Medical/ Clinical/ R&D/ FDA licensing Teams) and provide insight to ensure regulatory timelines are met or improved.
- Drive towards full compliance with regulatory requirements for India.

**Key Accountabilities (3/6)**:
DTAB/ DCC/ SEC meetings
- Track DTAB/DCC/SEC/other relevant stakeholder meetings and share intelligence related to our projects/ company.
- Prepare MOM summary of key meetings and projects relevant to Cipla

**Key Accountabilities (4/6)**:
**Preparation of regulatory monitor and market intelligence data**

Analyse and share market intelligence data and preparation of regulatory monitor capturing key regulatory developments on monthly basis.

**Key Accountabilities (5/6)**:
**Dossier review and coordination for submission**
- Actively co-ordinating with internal stakeholders for preparation of regulatory dossier as per DCGI requirement and follow up for its submission.
- Ensure the reduction of repeated queries and reduce timelines for approvals

**Key Accountabilities (6/6)**:
**Major Challenges**:
Managing internal stakeholders and meeting approval timeline.

**Key Interactions (1/2)**:
Regulatory Affairs, IPD, Portfolio, Medical Affairs, Clinical, plant location FDA team, Supply Chain, Corporate QA

**Key Interactions (2/2)**:
Zonal CDSCO office and DCGI office €'¹â‚¬'¹â‚¬'¹â‚¬'¹â‚¬'¹â‚¬'¹â‚¬'¹

**Dimensions (1/2)**:
Effective coordination with internal stakeholders to support in obtaining on-time / expedited regulatory approvals

**Dimensions (2/2)**:
**Key Decisions (1/2)**:
Decisions pertaining to Dossier review, checklists and submissions at DCGI office, internal coordination, pathway for key projects

**Key Decisions (2/2)**:
Recommendations on approval pathway, reduction of timelines, projects which are getting delayed/held up, any new project to be considered, streamlining processes.

**Education Qualification**:
B. Pharm/M.Pharm/ other regulatory certified courses will be preferred €'¹â‚¬'¹â‚¬'¹â‚¬'¹â‚¬'¹â‚¬'¹â‚¬'¹

**Relevant Work Experience**:
**Threshold skills and capabilities required to execute the role**: Technical knowledge of India Regulatory landscape, inter-personal skills

**Relevant experience**:**Minimum 5-10 years of experience in Regulatory Affairs

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