Job Description
Key Responsibilities:
- Develop global regulatory CMC strategies to ensure rapid approval of marketing applications, clinical trial submissions, and variations.
- Prepare and compile CMC sections for regulatory submissions (eCTD, CTAs, variations, supplements) worldwide.
- Lead a team of Subject Matter Experts (SMEs) in ensuring compliance with global eCTD requirements for Quality modules.
- Review and assess CMC data for gaps and risks, providing mitigation strategies.
- Manage Health Authority queries efficiently to secure timely approvals.
- Engage with global regulatory agencies (FDA, EMA, etc.) on CMC-related matters.
- Develop project plans and timelines for CMC submissions.
- Conduct global impact assessments for manufacturing changes and recommend regulatory strategies.
- Provide expert guidance on ICH, FDA, and EU CMC guidelines.
- Collaborate with internal teams, CMOs, and partners to align regulatory strategies.
- Represent Regulatory Affairs CMC in cross-functional project teams.
- Ensure Veeva compliance for CMC dossier management.
About IQVIA
IQVIA is a world leader in clinical research, commercial insights, and healthcare intelligence, supporting the life sciences and healthcare industries. We accelerate the development and commercialization of innovative treatments to improve patient outcomes and global health.
How to Apply
- Last Date: May 12, 2025
