Indegene MBBS Jobs – MDS, BDS Apply Online
Looking for an exciting career in regulatory solutions and medical writing? Join Indegene, a global leader in healthcare and technology, as an Associate Manager – Regulatory Solutions in Bangalore. This role offers an opportunity to contribute to clinical and regulatory filings while working in a dynamic, innovation-driven environment.
About Indegene
Indegene is a technology-driven healthcare solutions provider committed to transforming the future of healthcare. By blending deep industry expertise with cutting-edge technology, Indegene helps global pharmaceutical, biotech, and life sciences companies optimize their commercial, medical, regulatory, and R&D operations. With a strong focus on innovation, data-driven insights, and digital transformation, Indegene empowers healthcare organizations to stay future-ready. The company operates across multiple geographies, delivering AI-powered solutions, medical content services, regulatory support, and patient engagement strategies to enhance healthcare outcomes. At Indegene, professionals find dynamic career growth opportunities in a fast-paced, entrepreneurial work culture that fosters collaboration, innovation, and continuous learning.
Job Details
Job Role: Associate Manager – Regulatory Solutions
Location: Bangalore, KA, IN
Education: MBBS/PhD/MDS/BDS/MPharm/PharmD
Experience: 10 to 12 years’ experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5)
Role Purpose
The Associate Manager – Regulatory Solutions at Indegene is responsible for handling complex medical writing projects and supporting clinical and regulatory filings for global submissions. This role involves leading regulatory documentation efforts, providing review support, and ensuring compliance with international regulatory standards. Additionally, the candidate will be responsible for mentoring junior medical writers, ensuring high-quality deliverables, and contributing to cross-functional teams that drive regulatory success.
Skills
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- Experience in authoring a broad set of different clinical document types that support regulatory filings
- Lead cross-functional teams to draft agreed-upon scientific/ medical content
- Understanding of clinical development process
- Effective time management and organizational skills
Knowledge Requirement
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- Strong knowledge of regulatory guidelines/requirements
- Ability to interpret data and apply scientific knowledge to support regulatory document writing
Technology Skills
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- Expert authoring in MS Word
- Experience working in document management systems
Responsibilities
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- Prepare/review clinical study reports and other regulatory documents
- Coordinate and initiate activities for document review
Keywords: Indegene, Associate Manager, Regulatory Solutions, Healthcare, Technology, Clinical, Medical Writing, Document Management, Indegene MBBS Jobs – MDS, BDS Apply Online
