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.