Title: Lead- Regulatory Writing

Date: 29 Jul 2025

Location:

Mumbai, MH, IN

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

Prepare and compile global regulatory dossiers in eCTD and non eCTD format in accordance with HA legislations and client specific requirements
• Excellent working knowledge of regional regulations and guidance as it pertains to format and submission structure required. Understand, interpret, and apply Agency regulations and guidelines related to submissions
• Thorough understanding of all aspects of the publishing software, tools, process, and output requirements.
• Perform publishing QC tasks within the electronic publishing system and QC of the published output to ensure high submission quality. Perform document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolution.
• Dispatch submissions to Regulatory Authorities via agency portal, through customers or directly.
• Publish clinical documents (taking into account complexity and size) in accordance with department standards and organization KPIs.
• Ensure published clinical documents meet current internal and external quality standards for electronic and/or paper HA submissions, including minimizing publishing-related technical QC findings and no rework once finalized.
• Timeliness of deliverables meet both individual document and overall project timelines
Experience with global regulatory submission formats, including familiarity with submission publishing activities
• Experience with CSR document publishing, including familiarity with word and PDF formatting
• Thorough knowledge of major HA global/regional/national country requirements/regulatory affairs procedures for initial submission, licensing, post approval submission management
• Markets Handled: EU, US, Canada and GCC

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.