Associate Regulatory Affairs Specialist

5 days ago

Mumbai, Maharashtra, India Akaasa Infotech Noida Full time ₹ 6,00,000 - ₹ 18,00,000 per year

Job Title: Associate Regulatory Affairs Specialist

Experience: 5+ Years

Location: Mumbai(Hybrid mode)

Job Type: 12 months contract

REQUIREMENTS:

  • 5+ years supporting a regulatory or compliance organization.
  • Experience in Regulatory Affairs or a related field, particularly within a compliance function.
  • Hands-on experience with ETQ, RIMS, and document management systems.
  • Familiarity with Indian regulatory guidelines and global compliance standards.
  • Advanced proficiency in Microsoft Excel (VLOOKUP, Pivot Tables) and exposure to Power BI.
  • Experience with SAP ERP systems and EQT or similar quality tracking tools.

SUMMARY:

We are seeking a detail-oriented and collaborative Regulatory Affairs Analyst to support global regulatory processes and compliance initiatives. This role will contribute to the automation and maintenance of regulatory documentation within a RIMS workflow solution, ensuring data integrity and timely reporting across multiple geographic regions. The ideal candidate will be based in Mumbai and work closely with cross-functional teams, with flexibility to support global operations across time zones.

Key Responsibilities

  • Manage the global Registration, Notification, and Certification (RNC) process, including data entry, maintenance, and reporting in ETQ and other systems.
  • Generate and analyze SAP reports to ensure regulatory compliance; identify new stop codes using Excel functions like VLOOKUP.
  • Maintain and update master databases in Excel and Power BI; support monthly reporting and follow-ups with GRA teams.
  • Validate and monitor data in EQT systems for accuracy and compliance.
  • Collaborate with global teams to ensure timely regulatory submissions and documentation.
  • Support audits and maintain documentation aligned with regulatory standards.
  • Drive continuous improvement initiatives for data integrity and reporting processes.
  • Provide functional expertise in regulatory documentation and RIMS workflows.
  • Assist in maintaining standardized system approaches aligned with industry best practices.

Basic Qualifications

  • Bachelors degree in Sciences, Engineering, Regulatory Affairs, Pharmaceutical Sciences, Life Sciences, or a related discipline.
  • 2-3 years of experience in a regulated industry (e.g., medical device, pharmaceutical, cosmetic).
  • Proven ability to communicate effectively in written and spoken English.

Preferred Qualifications

  • 5+ years supporting a regulatory or compliance organization.
  • Experience in Regulatory Affairs or a related field, particularly within a compliance function.
  • Hands-on experience with ETQ, RIMS, and document management systems.
  • Familiarity with Indian regulatory guidelines and global compliance standards.
  • Advanced proficiency in Microsoft Excel (VLOOKUP, Pivot Tables) and exposure to Power BI.
  • Experience with SAP ERP systems and EQT or similar quality tracking tools.
  • Strong analytical, organizational, and leadership skills.
  • Demonstrated ability to work independently, manage multiple priorities, and meet deadlines.
  • Collaborative, responsive, and innovative problem solver with a global mindset.
  • Ability to work effectively in virtual teams across cultures and time zones.

Additional Skills

  • Ability to influence and engage across organizational levels.
  • Strong attention to detail and ability to retain confidential information.
  • Experience working in quality systems aligned with global regulations for Medical Devices, Consumer Products, and Cosmetics.
  • Technical aptitude to assess needs, identify issues, recommend solutions, and lead change initiatives.

Share your resume to:

Vishal Kumar

  • Regulatory Affairs Specialist

    3 days ago

    Navi Mumbai, Maharashtra, India CELOGEN PHARMA PVT LTD Full time ₹ 2,00,000 - ₹ 4,00,000 per year

    Company OverviewCelogen Pharma Pvt. Ltd. is a leading pharmaceutical formulations exporter & manufacturer based in India. The company provides it products and services in multiple countries globally including West Africa, East Africa, South Asia, South East Asia, the Middle East, South America & Europe. Apart from promoting our branded products in the retail...

  • Drug regulatory affairs

    1 week 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...

  • Global Regulatory Affairs Specialist

    2 weeks ago

    Navi Mumbai, Maharashtra, India G&L Scientific Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Contract: Permanent Full-TimeClosing Date: 05/12/25We are seeking Global Regulatory Affairs Specialists to provide critical subject matter expertise and backfill internal SMEs during a major regulatory transformation initiative. These roles will ensure continuity of day-to-day regulatory operations - particularly across CMC, labelling, and lifecycle...

  • Regulatory Affairs Executive

    5 days ago

    Mumbai, Maharashtra, India AMN Life Science Pvt. Ltd. Full time US$ 6,150 - US$ 7,600 per year

    Regulatory Affairs Executive - Pharma IndustryLocation:KurlaCompany:AMN Life Science Pvt Ltd (EU-GMP Pharmaceutical Manufacturing -100% Export)Experience:2-3 Years |Industry:Pharmaceuticals (OSD)Reports To:Manager Regulatory affairsRole Type:Full-TimePosition Overview:We are seeking a highly motivated and experiencedRegulatory Affairs Executiveto join our...

  • Manager - Regulatory Affairs

    3 days ago

    Mumbai, Maharashtra, India Digvijaya Management Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Candidate should be M.Pharmacy with 12 to 15 years of experience inRegulatory Affairs department from a reputed injectable manufacturing company,Manage regulatory affairs for injectable products, ensuring compliance with global regulations and guidelines.Develop and implement effective strategies to maintain product registrations, variations, and renewals...

  • Head -- Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Inventia Healthcare Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Title: Head Regulatory AffairsDepartment: Regulatory AffairsExperience: 20 + yearsLocation: ThaneReports To: R&D HeadPosition Summary:We are seeking an accomplished Regulatory Affairs leader with over 20 years of experience to head our global regulatory function. The ideal candidate will possess deep domain expertise in regulatory requirements across...

  • Regulatory Affairs Interns

    1 week 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...

  • Head of Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Inventia Healthcare Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Inventia is into pharmaceutical development and manufacturing from last 40 yrs. We partner with pharma companies to research, develop, manufacture and distribute OSD. Our Manufacturing plant is in Ambernath which produces range of OSD including capsules, tablets, Granules and Pellets.We are there in 45 countries and have 10 plus facility approvals including...

  • Regulatory Affairs Executive

    3 days ago

    Mumbai, Maharashtra, India Olive PharmaScience Ltd Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Company DescriptionOlive PharmaScience Ltd, an Indian pharmaceutical manufacturer with over five decades of experience, specializes in developing and manufacturing high-quality pharmaceuticals, OTC products, and dietary supplements. Renowned for its focus on advanced soft gelatin dosage forms, the company leverages its expertise in research and development...

  • Specialist Regulatory Affairs LCM

    1 week ago

    Mumbai, Maharashtra, India AdvanzPharma Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Location: Andheri, Mumbai(Hybrid working opportunity)About ADVANZ PHARMAADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on.Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare...