Associate- Regulatory Affairs

1 hour ago

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

Job 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 preparation, particularly for EU and emerging markets.

Key Responsibilities

  • Compliance & Lifecycle Management: Prepare variation and requalification dossiers. Manage regulatory product maintenance across EU, UK, WHO, and other emerging markets.
  • eCTD/CTD Sequence Review: Perform Level-1 review of CTD/eCTD sequences for DKT, FHI, and BO product submissions. Ensure submission quality and compliance with productivity and regulatory standards.
  • Query Handling & Documentation: Draft and review regulatory authority responses. Ensure clarity, regulatory alignment, and timely submission.
  • Functional File Preparation: Handle electronic publishing tasks including hyperlinking, bookmarking, redactions, and formatting. Ensure technical accuracy and reduce rework.
  • Artwork & Labeling Review: Review annotated artwork and comparative labeling texts. Ensure accuracy, consistency, and regulatory compliance.
  • Project Tracking & Documentation: Maintain trackers, task planners, product history logs, and query records. Ensure accurate and timely updates for internal and client reporting.
  • Team Collaboration & Communication: Facilitate smooth communication with internal stakeholders and external clients. Ensure timely follow-ups, documentation clarity, and professional engagement.

Educational Qualifications
B Pharm/ M Pharm

Soft Skills

  • Strong communication and interpersonal skills
  • Time management and multitasking
  • Analytical thinking and collaboration
  • Positive, adaptable attitude

Related Blog Post
Senior Manager-Regulatory Affairs-EU/US

Sr. Manager-Regulatory Affairs- US/EU Experience: -15+ YearsLocation: Gurgaon We 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 across these key markets, ensuring compliance and regulatory…

September 29, 2025

Assistant Manager – Regulatory Affairs – EU

Job Title: Assistant Manager – Regulatory Affairs (EU & UK)Location: Gurgaon, Haryana (India)Experience: 4–6 YearsQualification: Master's Degree in Pharmacy (M.Pharm or equivalent) Role OverviewWe are seeking a proactive and detail-oriented Assistant Manager – Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation,…

October 7, 2025

Project Manager – Regulatory Affairs

Job Summary: We are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successful product registration, market authorization, and compliance with relevant regulatory requirements. The ideal candidate will have a deep understanding of global regulatory frameworks,…

September 23, 2025

  • 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...

  • 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...

  • 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...

  • 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...

  • 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, 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...

  • Associate- Drug Regulatory Affairs_US_

    1 week 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...

  • R&D SRA Associate Analyst

    15 minutes ago

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

    OverviewR&D Regulatory Affairs Associate Analyst (L6) role provides:Support for PepsiCo concentrate business in India BU markets, to meet demand for compliant business-to-business beverage concentrates enabling innovation and reformulation, leading on critical regulatory compliance programmes meeting fast-paced dynamic regulatory landscape in South Asia...

  • R&D SRA Associate Analyst

    2 hours ago

    Gurgaon, Haryana, India Pepsico Full time ₹ 45,00,000 - ₹ 55,00,000 per year

    Overview R&D Regulatory Affairs Associate Analyst (L6) role provides:Support for PepsiCo concentrate business in India BU markets, to meet demand for compliant business-to-business beverage concentrates enabling innovation and reformulation, leading on critical regulatory compliance programmes meeting fast-paced dynamic regulatory landscape in South Asia...