Amarant Lifescience

Job Title: Executive / Senior Executive Regulatory Affairs (API) Location: Noida or Hyderabad, India Job Type: Full-Time Role Overview: We are seeking a motivated and detail-oriented Regulatory Affairs Professional to join our API regulatory team. The candidate will be responsible for preparing and reviewing eCTD sections of regulatory submissions (ASMF/CEP) and data packages for European markets, ensuring compliance with international regulatory standards. Key Responsibilities: Coordinate with cross-functional departments to arrange required technical data for ASMF/CEP and technical package preparation . Review quality and manufacturing data for APIs for regulatory adequacy as per relevant guidelines. Prepare ASMF/CEP dossier sections and technical documentation for submissions. Review DMFs of intermediates and APIs as part of vendor qualification. Assist in preparation of amendments, deficiency responses, and post-approval variations . Prepare and maintain a repository of API dossiers, regulatory commitments, and records . Support in drafting responses to regulatory authority queries based on available technical data. Experience, Education & Skills: Education: Bachelors degree (or higher) in Pharmacy, Chemistry, Biochemistry, or related scientific discipline . Experience: 2 - 5 years of experience in API regulatory submissions (ASMF/CEP) for European markets. Proficient in CTD/DMF/CEP documentation and submission processes. Familiarity with EMA and MHRA regulatory frameworks. Excellent written and verbal communication skills. Strong analytical, organizational, and problem-solving abilities. IT proficiency (MS Word/Excel) for document management and dossier preparation. High degree of professionalism and accountability with strong work ethics.