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!