Apply for Associate Regulatory Affairs at Amneal

Regulatory Affairs Associate – B Pharm/MSc. – Ahmedabad

Apply for Associate Regulatory Affairs at Amneal, Ahmedabad. Openings for B Pharm/MSc. with 1–3 years’ experience. Apply before 31st Aug 2025.

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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.

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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.

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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.

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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

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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.

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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)

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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.

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FAQs

Q1: Who can apply for this role?
Candidates with B Pharm, M.Pharm, MSc. 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.

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Summary Table

Company	Amneal Pharmaceuticals
Vacancies	1 (Regulatory Affairs Associate)
Required Education	B Pharm, M.Pharm, MSc., Regulatory Affairs
Experience	1–3 years in regulatory publishing/eCTD
Location	Ahmedabad, Gujarat

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📢 Apply today to advance your career in Regulatory Affairs with Amneal! Secure your spot before 31st August 2025.