Senior Manager-Regulatory Affairs-EU/US

15 hours ago


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

Full Time

Gurgaon

Posted 4 hours ago

Sr. Manager-Regulatory Affairs- US/EU

Experience: -15+ Years

Location: 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 excellence. The ideal candidate will bring 15+ years of proven experience in regulatory affairs, with a strong command of CMC regulations and a successful track record of managing complex global submissions.

Roles & Responsibilities
  • Lead CMC review of technical documentation for regulatory filings in US and EU markets, including Gap Analysis and Remediation for Module 3 (CMC).
  • Develop and implement regulatory strategies, processes, and timelines for new product registrations, variations, renewals, and post-approval changes in the US and EU.
  • Oversee the preparation, review, and submission of CTD dossiers, ensuring conformance with FDA, EMA, and ICH guidelines.
  • Critically evaluate submission documentation for scientific accuracy, compliance, and internal consistency.
  • Provide regulatory intelligence by tracking changes in US and EU regulations, guidelines, and best practices.
  • Collaborate closely with cross-functional teams (R&D, QA, Manufacturing, and Commercial) to ensure regulatory strategies are aligned with business objectives.
  • Represent the company in discussions with regulatory authorities (FDA, EMA, and other relevant agencies).
    • Mentor and guide junior regulatory team members, fostering a culture of regulatory excellence.
Education & Experience
  • Master's degree in Pharmacy (Pharma) or a related field.
  • 15+ years of regulatory affairs experience, with significant exposure to US and EU CMC submissions.
Knowledge, Skills & Abilities
  • In-depth knowledge of US FDA, EMA, and ICH CMC guidelines.
  • Strong ability to interpret and analyze complex technical and scientific data.
  • Exceptional oral and written communication skills, with strong presentation abilities.
  • Proven leadership and mentoring skills with a collaborative, results-driven style.
  • Excellent problem-solving and decision-making capabilities.
  • Proficiency with document management systems and Microsoft Office Suite (Word, PowerPoint, Excel, Outlook).
  • Ability to manage multiple priorities and deliver high-quality outputs under pressure.
Why Join Us?
  • Play a key leadership role in shaping regulatory strategies for high-priority US and EU markets.
  • Opportunity to lead impactful submissions and contribute to global product approvals.
  • Exposure to cross-functional teams and business strategies.
  • Work in a collaborative environment with a focus on innovation and regulatory excellence.
Related
Job Features
Job Category

Regulatory Affairs



  • 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...


  • 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...


  • Gurgaon, Haryana, India Glanbia Performance Nutrition Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    We are seeking a highly experienced and detail-oriented Regulatory Affairs professional to manage regulatory compliance for our Sports Nutrition portfolio across India and international markets. This individual contributor role involves reviewing product formulations, labels, and claims, ensuring alignment with FSSAI and global regulatory frameworks, and...


  • 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...


  • 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...


  • Gurgaon, Haryana, India Johnson & Johnson Innovative Medicine Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...


  • Gurgaon, Haryana, India myGwork - LGBTQ+ Business Community Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,...


  • Gurgaon, Haryana, India Evergreen Renewables Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    OverviewEvergreen Power is a US-based renewable energy company engaged in developing end-to-end infrastructure, construction and financing of wind and hybrid power projects, in India and US. Team capabilities span over 5000 MW of projects commissioned collectively.Evergreen Renewables is currently offering the position of Manager where you will be playing a...


  • Gurgaon, Haryana, India Sun Pharmaceutical Industries, Inc. Full time ₹ 25,00,000 - ₹ 50,00,000 per year

    Title: DGM/SM - Regulatory Affairs - CMC - BrandedDate: Sep 24, 2025Location: Gurgaon - R&DCompany: Sun Pharmaceutical Industries LtdJob Title:Sr. Manager / DGMBusiness Unit:Sun Global OperationsJob GradeG9A/G8Location :GurgaonAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take...


  • 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...