Regulatory Affairs Expert Lead

3 days ago


Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 21,00,000
Job Description

The Regulatory Affairs Expert Lead is a senior professional responsible for leading the preparation and submission of product registration dossiers, supplements, amendments, progress reports, and periodic experience reports.

This individual will interact with regulatory agencies to facilitate and expedite product approvals, serving as a regulatory liaison throughout the product lifecycle. The goal is to ensure compliance with global and local regulatory requirements.

The successful candidate will contribute to product planning and implementation, including regulatory strategy, risk management, and chemistry manufacturing control (CMC). They will also ensure timely approval of new drugs, biologics, or medical devices, and continued approval of marketed products.

This role requires strong expertise in submissions, regulatory strategy, and agency interactions. Experience in drug development, biologics, or medical devices is preferred. In-depth knowledge of regulatory requirements and processes is essential.

Required Skills and Qualifications
  • Bachelor's or Master's degree in a relevant field
  • Minimum 7 years of experience in Regulatory Affairs
  • Strong understanding of global and local regulatory guidelines
  • Excellent project management, analytical, and problem-solving skills
  • Strong written and verbal communication skills
  • Ability to work independently as a subject matter expert while collaborating with cross-functional teams


  • Mumbai, Maharashtra, India beBeeSpecialist Full time ₹ 15,24,000 - ₹ 2,01,12,000

    Job Description:We are seeking an experienced Regulatory Affairs Specialist to operate as an individual contributor under limited supervision. The role requires applying subject matter expertise in Regulatory Affairs to ensure compliance and successful product approvals. The ideal candidate will have the capacity to adapt their skills and knowledge to meet...

  • Project Lead

    1 week ago


    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job Title: Project Lead - Regulatory AffairsWe are seeking a highly skilled Project Lead to manage and coordinate project registrations for complex filings, including new product introductions. The ideal candidate will have a strong understanding of global regulatory requirements and be able to communicate effectively with cross-functional teams.Key...


  • Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 28,00,000 - ₹ 35,00,000

    Regulatory Affairs Expert RoleMain Objectives of the Position:A highly skilled and knowledgeable professional contributor with in-depth knowledge in Regulatory Affairs. The position demands executing complex or specialized projects, adapting precedent, and developing innovative solutions to overcome traditional approaches.Key Responsibilities:Leads the...


  • Mumbai, Maharashtra, India beBeeChemistry Full time US$ 8,00,000 - US$ 14,00,000

    Regulatory Affairs Lead PositionWe are seeking an experienced and skilled Regulatory Affairs Sub-Function team leader to oversee product registration submissions, progress reports, supplements, amendments, or periodic experience reports.Key Responsibilities:Supervise a team of professionals in directing product registration submissions, progress reports,...


  • Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 14,40,000 - ₹ 21,60,000

    Job Title: Regulatory Affairs ManagerAbout the RoleThis is an exciting opportunity for a highly skilled Regulatory Affairs professional to join our organization and contribute to the success of our team. We are seeking an experienced Regulatory Affairs Executive to lead our regulatory strategy, manage regulatory submissions, and maintain strong relationships...


  • 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,...


  • Mumbai, Maharashtra, India beBeeRegulatoryAffairsManager Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Regulatory Affairs Manager Job OpportunityJob Overview:The Regulatory Affairs Manager is responsible for overseeing the portfolio of pharmaceutical products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities, country distributors or external partners.Key Responsibilities:Manage the...


  • Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 9,00,000 - ₹ 12,00,000

    Regulatory Affairs Manager Job DescriptionThe 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,...


  • Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 90,00,000 - ₹ 1,50,00,000

    Regulatory Affairs SpecialistMain Purpose of Role:We are seeking a highly experienced and knowledgeable Regulatory Affairs Specialist to join our team. The ideal candidate will have comprehensive knowledge in the area of Regulatory Affairs and be able to execute complex projects.The Regulatory Affairs Specialist will direct the development of product...


  • Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Overview:">Lead Consultant - Regulatory Affairs Specialist. At our company, we are seeking an experienced and skilled professional to support our clients in regulatory affairs. The ideal candidate will have a strong background in chemistry, manufacturing, and controls (CMC) with excellent analytical and problem-solving skills.">The role involves...