Regulatory Specialist-II -CTA/IND Development delivery (Maharashtra)

Position Summary

You will support preparation and delivery of Clinical Trial Application (CTA) and Investigational New Drug (IND) submissions. You will work closely with global regulatory, clinical, CMC, quality and external partners. We value clear communicators who are organised, rigorous and collaborative. This role offers hands-on submission experience, growth in regulatory systems, and the chance to influence work that advances patient-focused science and innovation. This role will provide YOU the chance to lead key activities to progress YOUR career.

These responsibilities include some of the following: - Compile, format and deliver CTA/IND dossiers according to agreed strategy and timelines. - Coordinate document collection from clinical, CMC, quality and external vendors and track completeness. - Perform quality checks on dossier content to ensure compliance with regulatory expectations. - Maintain and update submission records in regulatory systems and carry out routine data checks. - Support responses to health authority questions and follow up on information requests. - Contribute to process improvements, system testing and creation of clear team guidance. Responsibilities - Deliver assigned submission components on time and to defined quality standards. - Identify and escalate risks or missing information that could impact delivery. - Communicate status updates and coordinate with cross-functional project teams. - Prepare regulatory correspondence and support preparation of supporting documentation. - Provide basic user support for submission tools and participate in user acceptance testing. - Help create clear work instructions and share knowledge across the team.

Why You

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals - Bachelor s degree in life sciences, pharmacy, chemistry or a related field. - 2 to 5 years of regulatory affairs, submissions or regulatory operations experience. - Practical experience preparing clinical trial or early-phase regulatory dossiers. - Working knowledge of regulatory requirements for CTA/IND submissions. - Experience with document management or submission systems and MS Office tools. - Good written and verbal English communication and ability to work with global teams.

Preferred Qualification

If you have the following characteristics, it would be a plus - Experience with electronic submission formats or systems such as Veeva Vault. - Familiarity with eCTD publishing or non-eCTD dossier structures. - Understanding of CMC and clinical documentation requirements for early-phase dossiers. - Experience in regulatory information management, data quality checks or tracking. - Prior experience in a regulated environment such as clinical research or manufacturing. - Postgraduate degree or professional certification in regulatory affairs or related field.