Regulatory Affairs Professional

2 weeks ago


Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

Job Description:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for authoring high-quality CMC documentation for US FDA submissions, ensuring technical congruency and regulatory compliance.

Responsibilities:

  • Document Authoring: Identify required documentation for US regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Review and Quality Control: Review and identify content, quality, and/or timeliness issues with source documents or any other potential authoring issues proactively.
  • Knowledge Management: Keep knowledge up-to-date with regard to regulatory guidelines and requirements in all global regions as well as new technical trends.
  • Stakeholder Coordination: Coordinate with stakeholders on a regular basis to extend all technical support required from a regulatory perspective.

Desired Skills:

  • eCTD Software Experience: Hands-on experience using eCTD software and attending e-publishing requirements throughout the project lifecycle.
  • Technical Knowledge: Good technical knowledge, review skills, and understanding of regulatory submissions.
  • Regulatory Submissions: Strong knowledge of CTD/eCTD requirements for submission of dossiers.
  • Problem-Solving: Ability to try new approaches when faced with challenges.
  • Analytical Skills: Should have good analytical and learning attitude.


  • Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 4,00,000 - ₹ 9,00,000

    Regulatory Affairs SpecialistOur ideal candidate will manage regulatory registrations, oversee certification renewal documents, and conduct internal audits.Job Description:Lead the management of REACH registrations across EU, Korea, Turkey, and UK, including tonnage upgrades and compliance letters.Handle customer inquiries and provide necessary declarations...


  • Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 30,00,000

    Job Overview:This role is responsible for overseeing the regulatory compliance and approval processes for new and existing products.Key Responsibilities:Develop and implement product registration strategies to ensure timely approvals.Collaborate with regulatory agencies to expedite pending registrations and resolve any discrepancies.Provide regulatory...


  • Navi Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 6,00,000 - ₹ 8,00,000

    Regulatory Affairs SpecialistOur organization is seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of US FDA regulations and ICH guidelines.Key Responsibilities:• Develop and implement regulatory strategies for new and existing products• Collaborate with cross-functional teams to...


  • 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...

  • Regulatory Affairs

    3 weeks ago


    Mumbai, Maharashtra, India CliniLaunch Research Institute Full time

    Job DescriptionPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB DESCRIPTION Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile...

  • Regulatory Affairs

    2 weeks ago


    Navi Mumbai, Maharashtra, India Peoplefy Full time

    &## ; We're Hiring: Regulatory Affairs – CMC Associate &## ; Location: Navi Mumbai &## ; Years of Experience:4+ years &## ; Work from Office &## ; Notice Period: Looking for immediate joiners Skills Required: &## ; Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field. &## ; 4+ years of experience in Regulatory Affairs...


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

    Regulatory Affairs Manager - Submission Publishing Job DescriptionJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to lead our submission publishing efforts. As a key member of our team, you will be responsible for delivering high-quality submissions while ensuring compliance with global health authority requirements.Key...


  • Mumbai, Maharashtra, India Tek Support Full time

    Job DescriptionJob Title: Regulatory Affairs Specialist Med/Pharma (Female)Location: RemotePosition Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities,...


  • Mumbai, Maharashtra, India Tek Support Full time

    Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring...


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

    Job Title: Regulatory Affairs Specialist Objective:The ideal candidate will prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements.Key Responsibilities:Screen and analyze documents received for product registration requests as per country-specific guidelines.Prepare, compile,...