Regulatory Affairs Associate – B.Pharm/M.Sc. – Ahmedabad
Apply for Associate Regulatory Affairs at Amneal, Ahmedabad. Openings for B.Pharm/M.Sc. with 1–3 years’ experience. Apply before 31st Aug 2025.
Amneal Pharmaceuticals, a global pharmaceutical leader, is hiring an Associate – Regulatory Affairs for its Ahmedabad office. This opportunity is ideal for life sciences and pharmacy graduates with a passion for regulatory publishing, eCTD submissions, and compliance. If you are detail-oriented and eager to advance your career in regulatory affairs, this role could be your next big step.
Company Overview
Amneal Pharmaceuticals (NYSE: AMRX) is one of the fastest-growing pharmaceutical companies with a diverse portfolio of generic and specialty medicines. With a strong commitment to innovation, compliance, and patient care, Amneal has established itself as a trusted partner across regulated markets including the US, EU, and other global territories. The company fosters a culture of excellence, inclusivity, and career growth, making it a preferred workplace for ambitious pharma professionals.
Job Role & Responsibilities
As an Associate – Regulatory Affairs (Document Level Publishing Specialist), your role will include:
- Collaborating with submission publishers to ensure accurate and timely document publishing.
- Performing daily PDF processing including bookmarking, hyperlinking, and Table of Contents creation.
- Conducting quality checks (QC) of PDF files and implementing corrections based on feedback.
- Troubleshooting document issues using ISI Toolbox and escalating unresolved challenges.
- Supporting eCTD submissions, ensuring adherence to regulatory authority requirements (FDA, EMA, etc.).
- Maintaining compliance with Amneal’s internal file naming conventions.
- Participating in team activities and providing peer support for regulatory submissions.
Eligibility / Qualifications
- Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related fields.
- Experience: 1–3 years in regulatory publishing, document management, or regulatory operations.
- Hands-on knowledge of eCTD submissions and regulatory document standards.
- Technical proficiency in PDF editing tools, ISI Toolbox, or similar systems.
- Certifications (preferred but not mandatory):
- Regulatory Affairs Certification (RAC)
- Training in eCTD publishing/document management tools
Location & Salary
- Job Location: Amneal Pharmaceuticals, 9th Floor, 901-911, Ahmedabad, Gujarat – 380051.
- Schedule: Full-time
- Salary: Competitive, aligned with industry standards.
- Work Environment: Collaborative, compliance-driven, and growth-oriented.
Application Process
Interested candidates can apply online through the official Amneal Careers portal:
👉 Click Here to Apply
📅 Application Deadline: 31st August 2025 (Apply before 08:15 AM IST)
Why Join Amneal?
- Work with a globally recognized pharma leader.
- Gain exposure to regulatory submissions in international markets.
- Competitive salary with opportunities for career advancement.
- Be part of an inclusive, innovative, and compliance-driven culture.
FAQs
Q1: Who can apply for this role?
Candidates with B.Pharm, M.Pharm, M.Sc. or related degrees, along with 1–3 years of regulatory publishing experience.
Q2: Do I need eCTD publishing experience?
Yes, candidates with eCTD submission knowledge will be preferred.
Q3: Is this an on-site role?
Yes, the position is based at Amneal’s Ahmedabad office.
Q4: What is the last date to apply?
The application deadline is 31st August 2025. Early applications are encouraged.
Summary Table
| Company | Amneal Pharmaceuticals |
|---|---|
| Vacancies | 1 (Regulatory Affairs Associate) |
| Required Education | B.Pharm, M.Pharm, M.Sc., Regulatory Affairs |
| Experience | 1–3 years in regulatory publishing/eCTD |
| Location | Ahmedabad, Gujarat |
📢 Apply today to advance your career in Regulatory Affairs with Amneal! Secure your spot before 31st August 2025.
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