Regulatory Affairs Specialist

20 hours ago

Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 9,00,000 - ₹ 12,00,000
Regulatory Affairs Manager Job Description

The role involves developing and executing regulatory strategies, compiling and reviewing regulatory submissions, ensuring product compliance and acting as a key liaison with regulatory agencies.

Key Responsibilities:

  • Submission Management: Preparation, review and submission of regulatory documentation (e.g., dossiers, applications) to health authorities.
  • Import License / Registration for Cosmetics Compliance: Ensure products and processes consistently adhere to all relevant national and international regulations and standards.
  • Regulatory Intelligence: Monitor and interpret changes in regulatory legislation and guidelines, providing actionable insights to internal teams and leadership.
  • Cross-Functional Collaboration: Work with R&D, manufacturing, quality assurance, and commercial teams to align product development and lifecycle management with regulatory requirements.

Requirements:

  • In-depth knowledge of regulatory affairs for Drug products, Nutraceuticals/Health Supplements.
  • Strong ability to analyze regulatory issues, trouble shooting and develop pragmatic solutions.
  • Excellent verbal and written communication skills to effectively interact with regulatory bodies, internal stakeholders and external customers.
  • Strong organizational skills and the ability to manage multiple priorities and projects simultaneously.

This is an exciting opportunity for a professional with expertise in regulatory affairs to join our team. As a Regulatory Affairs Manager, you will be responsible for leading cross-functional teams in regulatory environments, ensuring compliance with national and international regulations and standards.

  • Regulatory Affairs Specialist

    19 hours ago

    Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 18,00,000

    Regulatory affairs specialists play a vital role in ensuring compliance with regulatory requirements and facilitating the smooth operation of businesses.This position requires an individual with expertise in regulatory affairs, including experience with eCTD software and e-publishing requirements throughout the project lifecycle. The ideal candidate will...

  • Product Compliance and Regulatory Affairs Specialist

    16 hours ago

    Mumbai, Maharashtra, India beBeeproduct Full time ₹ 5,00,000 - ₹ 10,00,000

    Job TitleRegulatory Executive - Product Compliance and Regulatory Affairs Specialist

  • Regulatory Affairs Professional

    7 days ago

    Mumbai, Maharashtra, India beBeeSpecialist Full time US$ 40,000 - US$ 80,000

    Regulatory Affairs SpecialistThe role involves the compilation, submission and management of regulatory documentation for assigned projects.Responsibilities include maintaining accurate database records pertaining to products, in line with established systems and processes.Supporting and coordinating regulatory affairs projects, as assigned, including tender...

  • Regulatory Affairs Professional

    3 days ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000

    Regulatory Affairs ProfessionalJob Overview:We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes.Main...

  • Senior Regulatory Affairs Specialist

    3 days ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Regulatory Affairs SpecialistJob Description:We are seeking a detail-oriented Regulatory Affairs Specialist to support end-to-end submissions for global markets. This role involves exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key Responsibilities:Prepare Variation documents and/or evaluate...

  • Manager- Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Piramal Enterprises Full time

    Job DescriptionJob Description :Business: Piramal Critical CareDepartment: Regulatory AffairsLocation: KurlaTravel: LowJob OverviewThe Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities,...

  • Regulatory Affairs Professional

    4 days ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 2,20,00,000 - ₹ 2,54,00,000

    Regulatory Affairs LeaderSr Manager Regulatory Affairs responsible for developing and executing regulatory strategies, compiling and reviewing regulatory submissions, ensuring product compliance, and acting as a key liaison with regulatory agencies.Key Responsibilities:Submission Management:Preparing, reviewing, and submitting regulatory documentation to...

  • Senior Biologics Regulatory Affairs Specialist

    2 days ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000

    Biologics Regulatory Affairs Job OverviewThis role involves strategic planning, execution and delivery of biologics clinical trials across EU and US markets. The ideal candidate will possess expertise in biosimilar clinical development, regulatory affairs, and eCTD submissions.About the RoleThe successful candidate will be responsible for developing and...

  • AGM Regulatory Affairs

    4 weeks ago

    Mumbai, Maharashtra, India NMS Consultant Full time

    Job DescriptionAGM position -Regulatory AffairsB.Pharm / M.Pharm / M.Sc 12-14 years regulatory affairs experience majorly in USA market for Solid oral dosage formsKey Responsibilities:- Ensure timely submission of ANDAs, supplements and amendments- Review of registration dossiers, amendments, supplements and annual reports prepared by subordinates for...

  • AGM Regulatory Affairs

    4 weeks ago

    Mumbai, Maharashtra, India NMS Consultant Full time

    AGM position -Regulatory AffairsB.Pharm / M.Pharm / M.Sc– 12-14 years regulatory affairs experience majorly in USA market for Solid oral dosage formsKey Responsibilities:Ensure timely submission of ANDA's, supplements and amendments Review of registration dossiers, amendments, supplements and annual reports prepared by subordinates for adequacy and...