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ClosedPosted 430 days ago

425370 CTA IND Submission Lead (Open)

ScaleneWorks INC

Where
Bengaluru Luxor North Tower

This posting closed on 2026-10-23.

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This job: posted 430 days ago

The posting

425370 CTA IND Submission Lead (Open)

## Job Summary The CTA IND Submission Lead is responsible for leveraging detailed submission requirement knowledge and technical capabilities to deliver fit-for-purpose and quality submission packages per agreed schedules. This role plays a critical part in the preparation and management of Clinical Trial Application (CTA) packages, ensuring compliance with regulatory standards and efficient processes.

## Responsibilities - Prepare Clinical Trial Application (CTA) packages for both EU and Non-EU submissions, including authoring EU Application forms and market-specific documents. - Compile submission components such as the Investigator's Brochure (IB), protocol, and Investigational Medicinal Product Dossier (IMPD). - Manage the planning and project execution of authoring and compiling Development Safety Update Reports (DSURs) and new US Investigational New Drug applications and amendments (INDs). - Follow Regulatory System processes aligned with Global Regulatory Affairs (GRA) Standard Operating Procedures (SOPs), Work Instructions, and How to Guides. - Drive the implementation of efficient end-to-end processes while maintaining a patient-focused mindset. - Advocate for the use of Regulatory Systems with stakeholders and submission deliverable providers. - Ensure adherence to agreed Service Level Agreements (SLAs) and assess individual and team performance. - Participate in defining Ways of Working (WoWs) with stakeholders, focusing on continuous improvement and compliance with regulatory authority requirements.

## Qualifications - Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, or related discipline). - Strong knowledge of regulatory submission requirements and processes. - Excellent project management skills with the ability to manage multiple submissions simultaneously. - Proficient in authoring regulatory documents and understanding of clinical trial processes. - Strong communication and interpersonal skills to collaborate with cross-functional teams. - Detail-oriented with a focus on quality and compliance. - Ability to identify and implement automation opportunities for process improvement. - Familiarity with Global Regulatory Affairs (GRA) standards and practices.

## Preferred Skills - Experience with electronic submission systems and regulatory databases. - Knowledge of emerging investigational regulatory requirements across various regions. - Previous experience in a similar role within the pharmaceutical or biotechnology industry.

## Experience - Minimum of 5 years of experience in regulatory affairs or related field, with a focus on clinical trial submissions.

## Environment - Work setting is hybrid, combining both in-office and remote work. The position is based in Bengaluru Luxor North Tower.

## Salary - Estimated salary range: ₹4,000,000 per annum.

## Growth Opportunities - Opportunities for career advancement within the regulatory affairs team and potential leadership roles in submission management.

## Benefits - Comprehensive benefits package including health insurance, paid leave, and professional development opportunities.

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