Regulatory Affairs Associate - Clinical Trial Application (Parexel)

Roles and Responsibilities

• 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