🔬 Navigate Indian Regulatory Pathways for Global Clinical Research
We are seeking an experienced Senior Regulatory Affairs Specialist with deep expertise in Indian clinical trial regulations to support and lead regulatory submissions, stakeholder engagement, and compliance for global sponsors. This remote role requires in-depth knowledge of NDCT Rules, SUGAM, and CTRI, along with the ability to manage end-to-end clinical trial applications and amendments in India.
📍 Role: Remote (India-based) | Experience: 4-7 years
📋 Key Responsibilities:
- Serve as the subject matter expert on Indian clinical trial regulations, including NDCT Rules, SUGAM portal, and CTRI.
- Prepare, review, and submit Initial Clinical Trial Applications (CTA/iCTA), amendments, and responses via the SUGAM portal.
- Liaise effectively with global sponsors, cross-functional teams, and Health Authorities to ensure alignment and timely approvals.
- Prepare documentation, presentations, and briefing materials for SEC (Subject Expert Committee) meetings.
- Manage clinical trial registrations on the Clinical Trials Registry-India (CTRI) portal.
- Monitor and interpret updated guidelines and gazette notifications, providing actionable insights to sponsors and authorities.
- Develop and maintain submission delivery plans, content plans, and timelines, proactively updating stakeholders.
- Guide and mentor junior team members, fostering knowledge sharing and best practices.
👤 Essential Requirements:
- 4–7 years of hands-on experience in Indian clinical trial regulatory affairs.
- In-depth knowledge of NDCT Rules, SUGAM portal, CTRI, and SEC processes.
- Proven ability to prepare and submit CTA/iCTA, amendments, and query responses within strict timelines.
- Strong understanding of global regulatory expectations and harmonization with Indian requirements.
- Excellent oral and written communication skills in English.
- Ability to work independently, manage multiple priorities, and adapt to different time zones.
- Experience liaising with global sponsors and cross-functional teams.
- Cultural adaptability to collaborate efficiently with diverse stakeholders.
🌟 Preferred Qualifications:
- Experience in pharma, biotech, or CRO environments supporting global clinical trials in India.
- Familiarity with additional regulatory platforms and health authority interactions beyond SUGAM/CTRI.
- Mentoring or team leadership experience.
💼 Why Join This Role?
- Strategic Impact: Play a key role in enabling clinical trials in India for global drug development.
- Remote Flexibility: Work from anywhere in India with autonomy and responsibility.
- Expert Development: Deepen your expertise in evolving Indian regulations and global regulatory strategy.
- Global Collaboration: Interface with international sponsors and teams, expanding your professional network.
- Career Growth: Pathway to Regulatory Lead, Manager, or Consulting roles in clinical trial operations.
🌐 Ready to Lead Indian Clinical Trial Submissions for Global Sponsors?
👉 Apply Now for the Senior Regulatory Affairs Specialist (Remote) Position.
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We are an equal opportunity employer committed to diversity and inclusion in the workplace.
