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

  • Prepare, compile, and submit CTD/ACTD dossiers to global regulatory bodies.

  • Develop regulatory strategies for new and existing OSD products.

  • Collaborate with R&D, QA, QC, Production, Packaging, Clinical, and Legal teams for timely submissions.

  • Monitor and interpret global regulatory requirements (FDA, EMA, TGA, Health Canada, ROW).

  • Maintain regulatory documentation, SOPs, submission trackers and audit responses.

  • Review and approve labeling, artworks, packaging specifications, and promotional materials.

  • Act as the liaison with regulatory authorities for queries and approvals.

  • Track regulatory changes and guide internal teams with regulatory intelligence.

  • Support audit preparedness and participate in regulatory inspections.

Skills & Requirements

  • Strong knowledge of ICH, FDA, EMA and ROW regulatory guidelines.

  • Experience with eCTD preparation and electronic submission tools.

  • Excellent project coordination, communication, and documentation skills.

  • Detail-oriented with ability to multitask and handle tight timelines.

Benefits

  • Work exposure across multiple global markets.

  • EU-GMP compliant environment with advanced R&D capabilities.

  • Opportunity to enhance skills in global regulatory strategy and submissions.

CLICK HERE TO APPLY ONLINE