IQVIA is seeking a Regulatory Affairs Specialist in Bangalore, India, to join our dynamic team. This role is ideal for a highly skilled regulatory professional with 3-4 years of experience in the pharmaceutical or life sciences industry. As a Regulatory Team Leader, you will handle complex regulatory projects, including technical writing, documentation review, and client interactions.
If you have expertise in Chemistry, Manufacturing & Controls (CMC), Lifecycle Maintenance, Marketing Authorization Transfers, or Labeling, this could be the perfect opportunity for you!
Key Responsibilities (Job Description)
- Act as a Regulatory Team Leader on complex projects, ensuring compliance with global regulations.
- Prepare and review regulatory submissions (IND, NDA, MAA, etc.) and ensure timely approvals.
- Serve as a Subject Matter Expert (SME) in CMC, Labeling, or Regulatory Strategy.
- Build and maintain strong client relationships, addressing regulatory queries and presenting lessons learned.
- Manage project scope, budget, and timelines while ensuring high-quality deliverables.
- Guide and mentor junior regulatory staff, providing training and feedback.
- Represent IQVIA in client meetings, bid defenses, and regulatory discussions.
- Support SOP development, regulatory training, and process improvements.
- Stay updated with global regulatory guidelines (FDA, EMA, CDSCO, etc.).
Qualifications & Skills Required
Education:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
Experience:
- 3-4 years in Regulatory Affairs (Pharma/CRO/Healthcare).
- Strong knowledge of R&D processes (Preclinical, Clinical, CMC, Regulatory Submissions).
- Experience in eCTD publishing, labeling, or post-approval changes is a plus.
Skills:
- Excellent technical writing & communication skills.
- Proficiency in Microsoft Office, regulatory publishing tools (Veeva, DocuBridge, etc.).
- Ability to work independently & manage multiple projects.
- Strong problem-solving & decision-making abilities.
About IQVIA
IQVIA is a world leader in healthcare intelligence and clinical research, helping biopharma companies accelerate drug development and commercialization. With a presence in 100+ countries, we combine data science, technology, and human expertise to improve patient outcomes worldwide.
How to Apply
If you meet the qualifications and are ready to take on this exciting regulatory role, apply before the deadline:
📅 Last Date to Apply: June 21, 2025
📍 Location: Bangalore, India
