IQVIA is a global leader in advanced analytics, technology solutions, and contract research services, dedicated to driving healthcare forward. With a strong presence in clinical research and regulatory affairs, IQVIA provides innovative solutions to help pharmaceutical companies bring life-changing treatments to market. If you are passionate about regulatory processes and clinical trial management, this opportunity at IQVIA is perfect for you!
Responsibilities in Job
As a Regulatory & Start-Up Specialist 1, you will play a crucial role in ensuring compliance and facilitating smooth regulatory processes. Your responsibilities include:
- Preparing and submitting regulatory and ethics committee (EC) dossiers.
- Managing Informed Consent Forms (ICF) and ensuring compliance with ethical standards.
- Handling Clinical Trial Information System (CTIS) submissions.
- Utilizing Veeva Vault for regulatory documentation management.
- Collaborating with cross-functional teams to support clinical trials.
- Ensuring adherence to local and international regulatory guidelines.
Qualification
To be eligible for this role, candidates must meet the following qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
- Minimum 3+ years of experience in regulatory affairs and ethics committee submissions.
- Hands-on experience with ICF, CTIS, and Veeva Vault.
- Strong knowledge of clinical trial regulations and compliance standards.
Skills Required
- Expertise in regulatory dossier preparation and submission.
- Proficiency in CTIS and Veeva Vault platforms.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work in a hybrid environment with rotational shifts.
- Detail-oriented with strong organizational abilities.
Location & Work Mode
- Locations: Mumbai, Bangalore.
- Work Mode: Hybrid.
- Shift: Rotational.
How to Apply
If you are driven by innovation and excellence, we would love to hear from you!
📧 Interested candidates can share their resume with Navitha Gouli at navitha.gouli@iqvia.com.
