Executive - Regulatory Affairs (ROW)

4 days ago

Mumbai, Maharashtra, India FDC Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

We are seeking an experienced and detail-oriented Executive Regulatory Affairs (ROW) to join our Regulatory team. The ideal candidate will be responsible for preparing, reviewing, and submitting dossiers for semi-regulated and non-regulated markets, ensuring compliance with global regulatory requirements, and coordinating with internal departments and external stakeholders for product registration and documentation.

Key Responsibilities:

  • Prepare and compile regulatory dossiers for semi-regulated and non-regulated markets (ROW).
  • Respond to queries and deficiencies raised by the Ministry of Health (MOH) or buyers related to dossiers and submissions.
  • Coordinate the arrangement and dispatch of product samples, working standards, and other materials required for registration.
  • Gather and organize documentation required for tenders and complete relevant questionnaires accurately.
  • Liaise with manufacturing plants and cross-functional departments to obtain documents, samples, and data necessary for registration and submissions.
  • Support the Section Head in generating regulatory data and documentation as required by the Exports Department.
  • Ensure compliance with applicable international regulatory standards and maintain up-to-date knowledge of evolving global requirements.

Key Skills & Competencies:

  • Strong understanding of regulatory requirements for semi-regulated and non-regulated markets.
  • Excellent documentation, coordination, and communication skills.
  • Proficiency in dossier preparation, query handling, and submission tracking.
  • Ability to work collaboratively across departments and manage multiple projects simultaneously.
  • Attention to detail and strong organizational abilities.

  • Regulatory Affairs

    9 hours ago

    Mumbai, Maharashtra, India Actide International Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Job Description:works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.They must have excellent organizational, analytical, project management, and communication skills.They work frequently with other employees and team members to coordinate complex activities, often with...

  • Regulatory Affairs Executive Pharmaceutical Industry

    2 days ago

    Mumbai, Maharashtra, India Mahesh Bhupatrai Mehta Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Job Title: Regulatory Affairs Executive Pharmaceutical IndustryCompany: Classic EnterpriseLocation: Synergy Court, Malad West, Mumbai – 400064Industry: PharmaceuticalsEmployment Type: Full-timeExperience Required:6-8 yearsAbout Us:Classic Enterprise is a Mumbai-based pharmaceutical company located in the heart of Malad West. With a growing footprint in...

  • Senior Regulatory Affairs Executive

    2 weeks ago

    Mumbai, Maharashtra, India CareerFit Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Designation: Senior Executive Regulatory Affairs & QAJob Profile:Responsible for registration of Pharmaceutical, Nutraceutical, Cosmetic products especially in international markets like ROW, MENA, SEA, LATAM etc.Compile, Review & Submit the Dossiers to the Distributors as per the MOH guidelines.Coordinating & follow-up up with the suppliers and distributors...

  • Executive – Regulatory Affairs

    6 days ago

    Mumbai, Maharashtra, India Svizera Health Remedies Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Summary:We are seeking a detail-oriented and proactive Executive Regulatory Affairs to ensure compliance with all regulatory requirements related to product registration, documentation, and approvals. The role involves preparing and submitting regulatory dossiers, maintaining product licenses, and liaising with authorities to support timely market access...

  • Drug regulatory affairs

    2 days ago

    Mumbai, Maharashtra, India Statistical Insights Full time ₹ 5,00,000 - ₹ 6,95,334 per year

    Regulatory Affairs Specialist duties and responsibilitiesEnsuring compliance with all regulatory requirementsMaintaining regulatory documentation databaseAssisting with the preparation and submission of all regulatory reportsProviding accurate reviews of data and reportsEnsuring accurate and timely submissions to regulatory agenciesAdvising others on...

  • Regulatory Affairs Interns

    2 days ago

    Mumbai, Maharashtra, India Wellbeing Nutrition Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    About the Role:We are looking for a passionate and detail-orientedRegulatory Affairs Internto support our Regulatory team at Wellbeing Nutrition. This role offers a great opportunity to gain hands-on experience inNutraceutical and Nutrition regulatory processes.Key Responsibilities:Assist in ensuring all FSSAI licenses (NLPL, APOB) are up to dateSupport in...

  • Vice President Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Utkarsh Placement Pvt. Ltd. Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    One of our esteemed Pharma client based at Mumbai is looking for AVP/VP Regulatory Affairs for US Markets. Job Description is given below;Job Description – Vice President (VP) Regulatory AffairsIndustry:Pharmaceutical ManufacturingLocation: MumbaiExperience:20+ yearsQualification:BPharm/M.Pharm / Ph.D. in Pharmaceutical SciencesRole OverviewWe are seeking...

  • Associate, Regulatory Affairs

    1 week ago

    Mumbai, Maharashtra, India Colgate-Palmolive Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Relocation Assistance Offered Within Country Mumbai, Maharashtra, IndiaWho We AreColgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories...

  • Manager-Biologics Regulatory Affairs

    2 days ago

    Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    You will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables...

  • Assistant Manager-Regulatory Affairs

    4 days ago

    Mumbai, Maharashtra, India Baader Schulz Laboratories Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    We are seeking a detail-oriented and proactive Assistant Manager for Regulatory Affairs to join our team. The role involves preparing, reviewing and submitting regulatory documents aligned with Dossier preparation for CIS, Asian and African countries. The ideal candidate should have a strong knowledge of regulatory frameworks and experience in the...