Required Regulatory Affairs Associate at Indegene, M. Pharm, B. Pharm, M. Sc Apply before 20th December, 2023


Website Indegene

About Indegene

Indegene is a company that aims to revolutionize the healthcare industry through a combination of deep medical and scientific knowledge, cutting-edge technology, and innovative thinking. At Indegene, teams work on groundbreaking projects, pushing the boundaries of what’s possible, and striving to modernize an industry that has traditionally followed conventional practices. It’s clear that Indegene is committed to challenging the status quo and making a significant impact on healthcare.

Heading: Regulatory Associate Position Available

Subheading: Join a Dynamic Team Revolutionizing Regulatory Affairs in ASEAN Markets

Job Description

Role Purpose:

As a Regulatory Associate, you will play a pivotal role in planning, preparing, and submitting top-tier regulatory dossiers to the Health Authorities across ASEAN markets. This includes high-profile regions such as Australia, Cambodia, Hong Kong, Korea, Malaysia, Macao, Indonesia, Pakistan, Philippines, Singapore, Taiwan, Thailand, and Vietnam. Your expertise in global regulatory submission formats, including ACTD/eCTD/NeeS/Paper dossiers, will be essential.

Principal Responsibilities & Accountabilities:

  • Utilize basic medical/pharma/scientific knowledge to develop regulatory submission documents.
  • Demonstrate a thorough understanding of major Health Authority global/regional/national country requirements and regulatory affairs procedures.

Markets Handled: Australia, Cambodia, Hong Kong, Korea, Malaysia, Macao, Indonesia, Pakistan, Philippines, Singapore, Taiwan, Thailand, Vietnam

  • Prepare and compile global regulatory dossiers in ACTD, eCTD, and non-eCTD formats, aligning with ASEAN HA legislations and client-specific requirements.
  • Prioritize, plan, and monitor submissions for allocated products, while maintaining transparent communication on progress.

Additional Responsibilities:

  • Support and prepare Module 1 documents such as submission forms, cover letters, notification forms, and comparison tables.
  • Assist in post-approval regulatory filings, variations, and renewal applications.
  • Hands-on experience with regulatory document management systems and publishing tools.
  • Create submission packages aligned with regulatory strategy for pharmaceutical drugs, vaccines, generics, GMOs, and biological products.

Qualifications Required at Indegene:

  • Experience: 2-4 years in ASEAN markets.
  • Qualification: BPharm / MPharm / Pharm D / MSc
  • Location: Bangalore
  • Industry Type: Pharma/ Healthcare/ Clinical Research
  • End Date: 20th December, 2023

Join us and contribute to reshaping the future of regulatory affairs in the healthcare industry!

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