Regulatory Affairs Associate, Clinical Trial Application

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee timelines for query responses and guarantee timely submissions via the SUGAM portal or other regulatory platforms

• Implement and uphold submission delivery strategies, content planning, and proactively update designated stakeholders on progress

• Excellent communication skills with a talent for guiding and mentoring team members

• Capability to operate across various time zones

⛳️ Requirements

• 2-4 years of comprehensive knowledge of Indian regulatory guidelines pertaining to clinical trials, including NDCT Rules

• Practical experience with the SUGAM portal for Initial Clinical Trial Application (CTA/iCTA) submissions and amendments

• Proficiency in effectively liaising with global sponsors and cross-functional teams

• In-depth understanding of global regulatory standards and their alignment with Indian regulations

• Gained hands-on experience in managing and finalizing clinical trial registrations on the Clinical Trials Registry-India (CTRI) portal

• Current awareness of Guidelines and Gazette Notifications to provide suggestions/comments to relevant Regulatory authorities and Government bodies

• Familiarity with Indian regulatory processes, including the ability to adapt to strict Health Authority and Sponsor deadlines for submissions

• Strong oral and written communication abilities

• Openness to diverse cultural perspectives to collaborate effectively with client counterparts and internal stakeholders

• Capacity to work autonomously

🏝️ Benefits

• Health insurance

• Professional development opportunities