IQVIA is seeking a Regulatory Affairs Specialist in Bangalore, India, to join our dynamic team. As a Regulatory Team Leader, you will handle complex projects, prepare and review regulatory documents, and ensure compliance with global regulatory standards. This role is ideal for professionals with 3-4 years of experience in regulatory affairs who are looking to grow in a fast-paced, innovative environment.
Key Responsibilities:
✔ Act as a Regulatory Team Leader for complex projects, including technical writing.
✔ Prepare, review, and submit regulatory documentation in compliance with guidelines.
✔ Build strong relationships with clients and stakeholders, providing regulatory expertise.
✔ Serve as a Subject Matter Expert (SME) in Chemistry, Manufacturing & Controls (CMC), Lifecycle Maintenance, Marketing Authorization Transfers, Labeling, or Publishing.
✔ Manage project scope, deliverables, and budgets efficiently.
✔ Mentor junior team members and assist in their training and development.
✔ Present regulatory strategies at client meetings and bid defenses.
✔ Review and contribute to Standard Operating Procedures (SOPs).
✔ Conduct regulatory training sessions for internal teams.
Qualifications & Skills Required
✅ Bachelor’s or Master’s Degree in Life Sciences or a related field.
✅ 3-4 years of experience in regulatory affairs within the pharmaceutical or life sciences industry.
✅ Strong understanding of R&D processes (CMC, Preclinical, Clinical) and regulatory guidelines.
✅ Excellent communication, organizational, and project management skills.
✅ Proficiency in Microsoft Office, regulatory publishing tools, and software.
✅ Ability to work on multiple projects with minimal supervision.
✅ Strong problem-solving skills and adaptability in a fast-changing regulatory landscape.
✅ Knowledge of global regulatory submissions (US FDA, EMA, CDSCO, etc.) is a plus.
About IQVIA
IQVIA is a world leader in clinical research, healthcare analytics, and commercial solutions for the life sciences industry. We help biopharmaceutical companies accelerate drug development and commercialization while improving patient outcomes worldwide.
🔹 Why Join IQVIA?
✔ Work with a global leader in healthcare intelligence.
✔ Collaborative and innovative work environment.
✔ Opportunities for career growth and professional development.
✔ Competitive salary and benefits.
