Drug Regulatory Affairs Specialist

2 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, Haryana

Job 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 with global regulatory standards is essential.

Key Responsibilities:

  • Prepare and submit regulatory dossiers for various international markets (Middle East, Africa).
  • Ensure compliance with ICH, WHO, and other international regulatory frameworks.
  • Collaborate with internal teams to facilitate smooth product approvals globally.

Qualifications:

  • B.Pharm or M.Pharm with strong knowledge of international regulatory requirements (beyond CDSCO India).
  • Excellent documentation and communication skills.

Salary:
 Annual package: ₹3,00,000 to ₹3,60,000 (approx.)

How to Apply:

Please contact us via WhatsApp at or email your CV to

  • Associate- Drug Regulatory Affairs_US_

    4 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...

  • Associate- Drug Regulatory Affairs_Canada_

    4 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- Regulatory Affairs

    2 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...

  • Associate- Drug Regulatory Affairs_US_

    7 days ago

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

    DDReg PharmaDDReg PharmaFull TimeGurgaonPosted 4 hours 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...

  • Regulatory Affairs

    2 days ago

    Gurgaon, Haryana, India Vivchar Global Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Responsibilities:* Prepare regulatory dossiers for product approvals* Collaborate with cross-functional teams on dossier updates* Ensure compliance with drug regulations according to NAFDAC standards.* Manage LOAs, COAs & BDNAF submissions

  • Regulatory Affairs Associate

    2 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...

  • Senior Regulatory Specialist

    6 days ago

    Gurgaon, Haryana, India SUN PHARMA Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    We're hiring Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon.Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of ResponsibilityNew submissions:a. Review & prepare CMC...

  • Associate- Drug Regulatory Affairs_ GHC/KSA_

    1 week ago

    Gurgaon, Haryana, India e6f468b3-f068-4078-b55c-52e84010ae1f Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    DDReg PharmaDDReg PharmaFull TimeGurgaonPosted 11 hours 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...

  • 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...

  • Senior Manager-Regulatory Affairs-EU/US

    2 weeks ago

    Gurgaon, Haryana, India DDReg Pharma Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Full TimeGurgaonPosted 4 hours agoSr. Manager-Regulatory Affairs- US/EUExperience: -15+ YearsLocation: GurgaonWe are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US and EU regulatory frameworks. The role will drive regulatory strategy, dossier submissions, and lifecycle management activities...