Regulatory Affairs Specialist

2 weeks ago

Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 18,00,000

Job Title:

Global Regulatory Affairs Specialist

Description:

We are seeking a highly skilled Global Regulatory Affairs Specialist to support end-to-end submissions for global markets, including lifecycle management (LCM), Veeva Vault RIM, and complex initial and variation submissions.

Responsibilities:

  • Prepare variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to lifecycle management (LCM) activities by helping to compile and review CTD dossier modules.
  • Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / other countries.
  • Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
  • Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/other countries.
  • Utilize Veeva Vault RIM to track queries and manage submission workflows.
  • Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.

Requirements:

  • At least 3 years of experience in managing initial submissions, variations, and full LCM deliverables for global markets.
  • Must have experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/other countries.
  • Review of technical documents from manufacturing sites, such as specifications, batch manufacturing records, and validations, required for compilation of dossier sections/variation.
  • Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/other countries (Module 2 & 3).
  • Experience in providing regulatory strategies/evaluation by performing assessments of post-approval CMC changes considering global regulatory requirements.
  • Compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/other countries as per applicable regulatory guidelines.

  • Regulatory Affairs Specialist

    6 days ago

    Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Job OpportunityWe are seeking an experienced professional to join our team as a Regulatory Affairs Specialist.The successful candidate will be responsible for managing regulatory compliance, ensuring adherence to industry standards, and providing guidance on regulatory requirements.This is an exciting opportunity for someone looking to advance their career...

  • Regulatory Affairs Specialist

    3 weeks ago

    Bengaluru, Karnataka, India Biocon Biologics Full time

    Position SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...

  • Regulatory Affairs Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Biocon Biologics Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Position SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...

  • Regulatory Affairs Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Biocon Biologics Full time

    Position Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations...

  • Regulatory Affairs Specialist

    1 week ago

    Bengaluru, Karnataka, India Biocon Biologics Full time

    Position Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...

  • Regulatory Affairs Specialist

    2 weeks ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 30,00,000 - ₹ 45,00,000

    Job DescriptionAs a Regulatory Affairs Specialist, you will play a critical role in ensuring medical devices comply with regulatory requirements.Develop and manage document packages for regulatory submissions and renewals, focusing on EU Technical Files, MDSAP, and other regulated countries.Author Technical file documentation to support EU MDR requirements,...

  • Regulatory Affairs Specialist

    1 week ago

    Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 24,00,000

    Job Overview\We are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role involves preparing, reviewing, and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements.\The successful candidate will have a strong understanding of global regulatory guidelines and dossier...

  • Bioequivalence Regulatory Affairs Expert

    2 weeks ago

    Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 25,00,000 - ₹ 40,00,000

    Job OpportunityWe are seeking a skilled Regulatory Affairs Professional to manage regulatory activities for biosimilar products in the emerging LATAM market.This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations.Main Responsibilities:Develop and...

  • Global Regulatory Affairs Specialist

    1 week ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Global Regulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Global Regulatory Affairs Specialist to support the development and implementation of regulatory strategies for global markets.Key responsibilities include:Develop and implement regulatory strategies to ensure compliance with global regulatory requirements.Contribute to...

  • Regulatory Affairs Specialist

    2 weeks ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 11,02,300 - ₹ 16,30,500

    Regulatory Affairs ProfessionalOverviewWe are seeking a skilled Regulatory Affairs professional to join our team. The ideal candidate will have expertise in regulatory compliance, technical documentation, and quality assurance.Key ResponsibilitiesPrepare and submit regulatory documents, including technical files and product labeling, for EU and US...