Pharma Apply at Cipla For Regulatory Affairs Role, Apply Online
Posting Date: 4 Feb 2025
Country: India
State: Maharashtra
Location: Vikhroli
Req Id: 91953
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 teams to obtain all necessary documentation specific to products in compliance with regulatory requirements.
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 a regular basis
- Actively participate in regular discussions and planning with cross-functional teams (RA/ Portfolio/ Medical/ Clinical/ R&D/ FDA licensing Teams) and provide insights 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 prepare a regulatory monitor capturing key regulatory developments on a monthly basis.
Key Accountabilities (5/6) – Dossier review and coordination for submission
- Actively coordinate with internal stakeholders for preparation of regulatory dossiers as per DCGI requirements and follow up for submission.
- Ensure the reduction of repeated queries and reduce timelines for approvals.
Key Accountabilities (6/6) – Major Challenges
- Managing internal stakeholders and meeting approval timelines.
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.
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 the DCGI office, internal coordination, and pathway for key projects.
Key Decisions (2/2)
- Recommendations on approval pathway, reduction of timelines, projects that are getting delayed/held up, any new projects to be considered, and streamlining processes.
Education Qualification:
- B. Pharm/M. Pharm/ other regulatory certified courses will be preferred.
Relevant Work Experience:
- Threshold skills and capabilities required to execute the role: Technical knowledge of the India Regulatory landscape, inter-personal skills.
- Relevant experience: Minimum 5-10 years of experience in Regulatory Affairs.
