Senior Regulatory Affairs Specialist

7 days ago

Ghaziabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000
Regulatory Affairs Professional

We are seeking a detail-oriented Regulatory Affairs Associate to support end-to-end submissions for global markets. This role involves managing initial submissions, variations, and full lifecycle management deliverables.

Key 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 various countries including the US, EU, SA, WHO, ANZ, and others.
  • 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 various 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.

Required Skills and Qualifications:

  • A minimum of 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 various countries.
  • Hands-on experience in initial dossier compilation for various countries (Module 2 & 3).
  • Experience in providing Regulatory strategies/Evaluation by performing assessment of post-approval CMC Changes considering global regulatory requirements.

Benefits:

This position offers a unique opportunity to work with a dynamic team and contribute to the success of our organization. If you are a motivated and detail-oriented individual with a passion for Regulatory Affairs, we encourage you to apply.

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Ghaziabad, Uttar Pradesh, India beBeeGovernment Full time ₹ 15,82,500 - ₹ 25,17,500

    Job Title: Senior Regulatory Affairs SpecialistWe are seeking a seasoned professional to build and maintain relationships with government officials and regulatory bodies, ensuring our company's compliance with relevant laws and regulations. This role requires strong communication, negotiation, and relationship-building skills, as well as a deep understanding...

  • Regulatory Affairs Specialist

    5 days ago

    Ghaziabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000

    Job Opportunity: Regulatory Affairs ProfessionalThe Regulatory Affairs Executive plays a crucial role in ensuring compliance with international guidelines and country-specific requirements. This involves preparing, reviewing, and maintaining regulatory documents to support product registrations, timely dossier submissions, query responses, and compliance...

  • Regulatory Affairs Expert

    2 weeks ago

    Ghaziabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000

    Regulatory Affairs Expert WantedWe are seeking a seasoned Regulatory Affairs expert to join our team. The ideal candidate will have extensive knowledge of international food regulations and experience in leading regulatory intelligence across multiple markets.Key Responsibilities:Monitor, analyze, and interpret global regulatory updates and translate them...

  • Life Sciences Regulatory Specialist

    2 weeks ago

    Ghaziabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 80,00,000

    About the RoleAs a regulatory solutions specialist, you will play a pivotal role in monitoring and analyzing the global regulatory landscape within the life sciences industry. You will support our products and services by actively participating in global surveillance and data acquisition activities.Key ResponsibilitiesMonitor global regulatory intelligence...

  • Lead Food Regulatory Affairs Specialist

    5 days ago

    Ghaziabad, Uttar Pradesh, India beBeeFoodRegulation Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job OpportunityWe seek a highly skilled and motivated professional to lead and manage activities in the Food Regulatory Affairs. This role is focused on driving policy initiatives, liaising with government departments, engaging with industry stakeholders, generating revenue, and organizing impactful initiatives.The ideal candidate will possess a strong...

  • Medical Device Regulatory Professional

    2 weeks ago

    Ghaziabad, Uttar Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

    **Regulatory Affairs Specialist: Secure Global Product Compliance**We are seeking an experienced Regulatory Affairs professional with a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.Key Responsibilities:Prepared, reviewed, and...

  • Senior Medical Affairs Professional

    5 days ago

    Ghaziabad, Uttar Pradesh, India beBeeMedicalAffairs Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Medical Affairs Lead RoleJob Description:The Medical Affairs Lead will spearhead the development and execution of a comprehensive medical affairs strategy. This includes providing strategic support to the marketing team, facilitating collaboration between medical and marketing teams, and ensuring alignment with business goals and regulatory...

  • Senior Medical Device Compliance Expert

    2 weeks ago

    Ghaziabad, Uttar Pradesh, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000

    Job Title: Executive Quality Assurance and Regulatory Affairs Specialist"],

  • Regulatory Compliance Specialist

    6 days ago

    Ghaziabad, Uttar Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title:Regulatory Compliance SpecialistJob Summary:This role involves working with regulatory bodies, ensuring that vehicles meet the required standards. As a Regulatory Compliance Specialist, you will be responsible for analyzing and implementing new regulations to ensure compliance.About the Role:Develop process knowledge in vehicle homologation...

  • Executive Director of Government Affairs

    1 week ago

    Ghaziabad, Uttar Pradesh, India beBeeStrategist Full time ₹ 1,50,00,000 - ₹ 2,20,00,000

    Job Overview">The successful candidate will lead our policy advocacy and influence efforts to ensure a favorable business environment.This role involves managing stakeholder relationships, including government officials, to advance our company's interests.Key responsibilities also include developing and executing crisis communication protocols to protect our...