Regulatory Affairs Specialist

1 day ago


Dombivli, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 17,00,000 - ₹ 25,15,000
Job Title: Regulatory Affairs Specialist Job Summary:

We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for preparing, reviewing, and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements.

 Key Responsibilities:
  • Document Preparation and Review: Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements.
  • Regulatory Query Management: Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
  • Audit Support: Ensure timely preparation and submission of documents related to audit findings.
 Requirements:
  • Education: Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
  • Experience: 3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
  • Skills: Strong understanding of global regulatory guidelines, dossier preparation, MS Office (Word, Excel, PowerPoint), and document management systems.
 

At our organization, we promote diversity and equality. We encourage applications from talented individuals who share our values and are committed to excellence.



  • Dombivli, Maharashtra, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 20,00,000

    Regulatory Affairs ProfessionalThe role of a Regulatory Affairs Professional is crucial in ensuring compliance with regulatory frameworks. The ideal candidate will have expertise in handling filings, tariff determination, and other regulatory submissions.Key Responsibilities:Manage regulatory filings, tariff determination, and petitions before...


  • Dombivli, Maharashtra, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

    Regulatory Affairs ExpertiseWe are seeking a detail-oriented Regulatory Affairs-CMC Professional to support the development of comprehensive regulatory strategies for global markets.Key Responsibilities:Develop and implement Variation documents and evaluate post-approval CMC changes in compliance with international regulatory requirements.Contribute to...


  • Dombivli, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Opportunity:We are seeking an accomplished Regulatory Affairs professional to join our team.Key Responsibilities:Compliance Management: Ensure regulatory compliance with international, federal, and local requirements across pharmaceuticals and medical devices.Documentation Submission: Prepare, review, and submit regulatory filings, including IND, NDA,...


  • Dombivli, Maharashtra, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,30,00,000

    Senior Regulatory Affairs Specialist Job DescriptionThis role oversees the management of CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing. The ideal candidate will lead cross-functional teams to gather required documentation and data.Main Responsibilities:Manage CMC regulatory activities for USFDA...


  • Dombivli, Maharashtra, India beBeeMedicinal Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Medical Affairs Strategy LeaderThe Medical Affairs Strategy Leader will drive the medical affairs strategy at our organization, focusing on providing robust medico-marketing support and facilitating collaboration between the medical and marketing teams.This role encompasses the development of medical materials, training programs, and evaluation of new...


  • Dombivli, Maharashtra, India beBeeCompliance Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

    Regulatory Compliance SpecialistWe are seeking an experienced Regulatory Compliance Specialist to join our esteemed organization in the Medical Device Industry.Key Responsibilities:Ensure compliance with regulatory requirements such as ISO 13485, MDD, MDR, GMP, GDP, and QMS.Coordinate with local authorities for obtaining required permissions and...


  • Dombivli, Maharashtra, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,20,00,000

    Job Overview:">We are seeking a detail-oriented and proactive professional to join our team as a Senior Compliance Analyst. This role requires someone with excellent analytical skills, attention to detail, and the ability to collaborate across departments to maintain the highest standards of corporate governance and ethics.">Key Responsibilities:">">Employee...


  • Dombivli, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

    Compliance LeadThe role of the Senior Compliance Manager is a pivotal one, ensuring our organization remains in compliance with regulatory requirements. Key responsibilities include preparing and reviewing compliance reports, monitoring investment limits, drafting policies and procedures, and overseeing day-to-day compliance tasks.Candidates for this...


  • Dombivli, Maharashtra, India beBeeRegulatory Full time ₹ 25,00,000 - ₹ 30,00,000

    Job Title: AI Regulatory SpecialistWe are seeking a skilled AI Regulatory Specialist to join our team. The successful candidate will have experience in designing and deploying AI-driven regulatory change monitoring solutions.The ideal candidate will have a strong understanding of prudential and transaction reporting frameworks, including Basel III/IV, EMIR...


  • Dombivli, Maharashtra, India beBeeRegulatory Full time US$ 50,000 - US$ 80,000

    Job DescriptionWe are seeking a highly skilled Regulatory Intelligence Coordinator to join our team. The successful candidate will be responsible for monitoring and analyzing the global regulatory landscape within the life sciences industry.This role is ideal for someone who enjoys diving deep into data, has strong analytical skills, and thrives in a...