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Team Member - Regulatory Affairs

5-10 years
Not Disclosed
10 Feb. 7, 2025
Job Description
Job Type: Full Time Education: B. Pharm/M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Team Member – Regulatory Affairs

Posting Date: February 4, 2025
Country: India
State: Maharashtra
Location: Vikhroli
Req ID: 91953

Division: Corporate Affairs

Department: Corporate


Job Purpose

The Team Member – Regulatory Affairs will be responsible for coordinating dossier checklists, preparing submissions, following up for regulatory approvals, and ensuring compliance with Indian regulatory requirements. The role involves close collaboration with Regulatory Affairs (RA), IPD, Portfolio, Medical Affairs, Marketing, and other internal teams to secure approvals efficiently.


Key Responsibilities

1. Product Approval & Regulatory Tracking

  • Monitor the approval status of products in India (DCGI) and globally.
  • Track the CDSCO banned product list and analyze its impact on Cipla’s brands.
  • Maintain regulatory approval checklists and ensure compliance with requirements.

2. Cross-Functional Collaboration

  • Engage with Regulatory Affairs, Portfolio, Medical, Clinical, R&D, and FDA licensing teams to align on regulatory timelines.
  • Ensure regulatory compliance is fully met for India.
  • Provide insights during discussions to improve regulatory timelines and streamline approvals.

3. DTAB/DCC/SEC Meetings & Regulatory Intelligence

  • Track DTAB, DCC, SEC, and other key regulatory meetings.
  • Document and summarize meeting outcomes relevant to Cipla.
  • Provide regulatory intelligence updates for strategic decision-making.

4. Market Intelligence & Regulatory Monitoring

  • Analyze and share market intelligence data.
  • Prepare monthly regulatory monitoring reports capturing key regulatory developments.

5. Dossier Preparation & Submission

  • Coordinate dossier preparation with internal stakeholders as per DCGI requirements.
  • Ensure timely submission and reduce approval delays by minimizing repeated queries.
  • Optimize submission timelines and approval processes.

Key Challenges & Solutions

Challenges Proposed Solutions
Managing multiple internal stakeholders Proactive coordination & structured workflow
Meeting strict approval timelines Process optimization & regulatory intelligence tracking

Key Interactions

Internal Stakeholders

  • Regulatory Affairs, IPD, Portfolio, Medical Affairs, Clinical, Plant FDA Team, Supply Chain, Corporate QA

External Stakeholders

  • Zonal CDSCO Office, DCGI Office

Decision-Making & Business Impact

Key Impact Areas

  • Faster regulatory approvals with efficient dossier management.
  • Compliance with evolving regulatory frameworks.
  • Enhanced regulatory intelligence for strategic planning.

Key Decisions

  • Dossier review & submission strategies.
  • Approval pathways & process streamlining.
  • Recommendations to reduce approval timelines & mitigate project delays.

Qualifications & Experience

Education:

  • B.Pharm / M.Pharm
  • Regulatory certification courses preferred

Experience:

  • 5-10 years of experience in Regulatory Affairs.
  • Strong understanding of the Indian regulatory landscape and stakeholder management.

Job Location: Vikhroli, Maharashtra

Shift Hours: [Specify]