DRA (Drag Regulatory Affair) Assistant Manager

22 hours ago

Gurgaon, Haryana, India Bal Pharma Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Roles and Responsibilities (5 days working)

  • Manage regulatory dossiers for solid oral products, including CTD and ACTD preparation and submission to global markets.
  • Handle team responsibilities related to dossier compilation, review, and approval.
  • Ensure compliance with GMP regulations and provide guidance on regulatory affairs matters within the organization.
  • Collaborate with cross-functional teams to ensure timely completion of tasks and meet project deadlines.
  • Provide expertise in ASEAN, LATAM markets Team Handling, and Dossier Preparation.

Desired Candidate Profile

  • M.Pharma degree from a recognized university with 10-12 years of experience in drug regulatory affairs.
  • Strong understanding of CTD ACTD format for regulatory submissions (USFDA & EU).
  • Experience working on Solid Orals formulations is essential.
  • Excellent communication skills for effective collaboration with internal stakeholders and external partners.

  • Associate- Regulatory Affairs

    3 days ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Job PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for EU and emerging markets.Key...

  • Associate- Regulatory Affairs

    5 days ago

    Gurgaon, Haryana, India DDReg Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    DDReg PharmaDDReg PharmaFull TimeGurgaonPosted 14 minutes agoJob Purpose:We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier...

  • DRA (Drug Regulatory Affair) Assistant Manager

    3 days ago

    Gurgaon, Haryana, India Bal Pharma Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Roles and Responsibilities (5 days working)Dossier (CTD, ACTD & Country Specific Format) review for Latam, ASEAN, CIS & African countries.Collaborate with various departments within the organization, such as Plant (QA, QC, Production, Packing & Purchase) and R&D, to gather the necessary inputs for regulatory submissions.Compilation and timely submission of...

  • DRA Executive

    1 week ago

    Gurgaon, Haryana, India Sidhaant Life Sciences Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Drug Regulatory Affairs will be responsible for compiling, reviewing, and submitting dossiers and regulatory documents for drug product approvals in international markets. Prepare, review, & submit (CTD/eCTD/ACTD formats) for new drug applications. Required Candidate profileB.Pharm/ M.Pharm in Life Sciences.2–5 years of experience in Regulatory...

  • Regulatory Affairs Associate

    5 days ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    JOB PURPOSE:We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support globalregulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for EU and emerging markets.Key...

  • Regulatory Affairs Intern

    1 week ago

    Gurgaon, Haryana, India Philips Full time ₹ 4,00,000 - ₹ 6,00,000 per year

    Job TitleRegulatory Affairs InternJob DescriptionYour role:Tracking and establishing Process of PC& PNDT (Pre Conception & Pre Natal Diagnostic Techniques) regulations at the District / State level for the sale / supply / demonstration of medical devices that come under PC& PNDT regulations.Tracking and establishing Process of AERB (Atomic Energy Regulatory...

  • Associate- Drug Regulatory Affairs_Canada_

    6 days ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time US$ 60,000 - US$ 1,20,000 per year

    Job PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for Canada Markets.Key...

  • Associate- Drug Regulatory Affairs_US_

    6 days ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Job PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for US Markets.Key...

  • Drug Regulatory Affairs Specialist

    5 days ago

    Gurgaon, Haryana, India Sam Global Bio care Pvt. Ltd. Full time ₹ 3,00,000 - ₹ 3,60,000 per year

    Company: Sam Global Biocare Pvt. Ltd.Location: Gurgaon (Gurugram), Sector 67, HaryanaJob Description:Sam Global Biocare Pvt. Ltd. is looking for a skilled Drug Regulatory Affairs Specialist with a strong understanding of international regulatory guidelines. Our focus is on exporting to the Middle East and expanding into African markets, so familiarity...

  • Manager - Aeropolitical Affairs

    1 week ago

    Gurgaon, Haryana, India IndiGo (InterGlobe Aviation Ltd) Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Manager – Aeropolitical AffairsReporting to: Senior Manager – Aeropolitical & Industry AffairsThe Manager – Aeropolitical Affairs will be responsible for supporting the Department in expanding traffic rights and market access for IndiGo and will also be responsible for ensuring adherence to regulatory requirements as required to expand and maintain...