Pharma Jobs at AMN Life Science Pvt. Ltd – Apply on Pharmanika
Looking for high-growth opportunities in the pharmaceutical sector? Pharma Jobs at AMN Life Science Pvt. Ltd – Apply on Pharmanika to explore top roles in regulatory affairs, quality, manufacturing, and export-focused pharma operations. This update brings you the latest openings, eligibility details, and application information for candidates aiming to build a strong career in the pharma industry.
AMN Life Science Pvt. Ltd.
Regulatory Affairs Executive
Location: Kurla, Mumbai, Maharashtra (On-site)
Experience: 1–3 years
Qualification: B.Pharm / M.Pharm / Regulatory Affairs Certification
Salary: ₹4.5–5.5 LPA
Job Description – Regulatory Affairs Executive
AMN Life Science Pvt. Ltd., an EU-GMP approved pharmaceutical manufacturer specializing in export-focused OSD formulations, is hiring a Regulatory Affairs Executive for its Mumbai location. This role is ideal for professionals with hands-on experience in CTD/ACTD submissions and exposure to global regulatory markets including FDA, EMA, TGA, Health Canada, and ROW.
Key Responsibilities
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Prepare, compile, and submit CTD/ACTD dossiers to global regulatory bodies.
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Develop regulatory strategies for new and existing OSD products.
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Collaborate with R&D, QA, QC, Production, Packaging, Clinical, and Legal teams for timely submissions.
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Monitor and interpret global regulatory requirements (FDA, EMA, TGA, Health Canada, ROW).
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Maintain regulatory documentation, SOPs, submission trackers and audit responses.
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Review and approve labeling, artworks, packaging specifications, and promotional materials.
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Act as the liaison with regulatory authorities for queries and approvals.
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Track regulatory changes and guide internal teams with regulatory intelligence.
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Support audit preparedness and participate in regulatory inspections.
Skills & Requirements
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Strong knowledge of ICH, FDA, EMA and ROW regulatory guidelines.
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Experience with eCTD preparation and electronic submission tools.
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Excellent project coordination, communication, and documentation skills.
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Detail-oriented with ability to multitask and handle tight timelines.
Benefits
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Work exposure across multiple global markets.
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EU-GMP compliant environment with advanced R&D capabilities.
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Opportunity to enhance skills in global regulatory strategy and submissions.
