Amneal Pharmaceuticals, a global leader in generic and specialty medicines, is inviting applications for the role of Associate, Regulatory Affairs in Ahmedabad, Gujarat. This is a rewarding opportunity for candidates with expertise in document publishing, eCTD submissions, and regulatory operations.
If you are passionate about regulatory compliance, attention to detail, and contributing to global healthcare access, this role could be your perfect next step.
🔑 Key Responsibilities
As a Document Level Publishing (DLP) Specialist – SIE RA, you will:
- Collaborate with submission-level publishers to ensure timely and accurate document publishing.
- Perform daily PDF processing including bookmarking, hyperlinking, and TOC creation.
- Conduct quality control (QC) checks for accuracy and formatting consistency.
- Troubleshoot technical issues using ISI Toolbox or similar publishing tools.
- Ensure compliance with eCTD structure, timelines, and regulatory authority standards (FDA, EMA).
- Adhere to file naming conventions for document traceability.
- Participate in team activities and support peers in eCTD submissions.
🎓 Qualifications & Skills
- Education: Bachelor’s/Master’s in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
- Experience: 1–3 years in regulatory publishing, document management, or eCTD submissions.
- Technical Skills:
- Proficiency in PDF editing tools (bookmarking, hyperlinking, TOC).
- Hands-on with ISI Toolbox or equivalent regulatory publishing systems.
- Strong quality control and troubleshooting abilities.
- Certifications (Preferred): Regulatory Affairs Certification (RAC), eCTD publishing tool training.
🌟 Why Join Amneal Pharma?
- Work with a leading global pharmaceutical company.
- Gain exposure to international regulatory submission standards.
- Opportunity to grow within regulatory operations and publishing.
- Inclusive and diverse workplace culture.
