Senior Regulatory Affairs Associate

Regulatory Affairs Associate (Clinical Trial Application)

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

• 2-4 yrs yrs in-depth knowledge of Indian regulatory guidelines for clinical trials, including NDCT Rules.
• Hands-on experience with SUGAM portal for Initial Clinical Trial Application (CTA/iCTA) submissions and amendments.
• Ability to liaise effectively with global sponsors and cross-functional teams.
• Prepare necessary documentation, presentations, and briefing materials for SEC meetings
• Strong understanding of global regulatory expectations and harmonization with Indian requirements.
• Acquired hands-on expertise in managing and completing clinical trial registrations on the Clinical Trials Registry-India (CTRI) portal.
• Updated with current Guidelines and Gazette Notifications to give suggestions/comments to respective Regulatory authorities and Govt. regulatory bodies.
• Working knowledge of India regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissions
• Manage timelines for query responses and ensure on-time submission through SUGAM portal or other regulatory platforms.
• Clear oral and written communication skills
• Acceptability towards varied cultural mindsets to collaborate efficiently with client counterparts and other internal stakeholders as well
• Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Strong communications skills and ability to guide and mentor team members.
• Ability to work in different time zones
• Ability to work independently

Experience Level

Mid Level