Regulatory Affairs Specialist

1 day ago

Amrāvati, Maharashtra, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000

Job Description

We are seeking a detail-oriented regulatory specialist to support end-to-end submissions for global markets. The successful candidate will have experience with lifecycle management, Veeva Vault RIM, and complex initial and variation submissions.

Key Responsibilities:

  • Prepare variation documents and/or evaluate post-approval changes in compliance with global regulatory requirements.
  • Contribute to lifecycle management activities by helping to compile and review dossier modules.
  • Compile initial dossiers for US/EU/SA/WHO/ANZ/Other Countries.
  • Provide regulatory strategies and conduct evaluations of post-approval 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 & analytical validations, batch analysis data, and stability data.

Required Skills and Qualifications

  • 3+ years of experience in managing initial submissions, variations, and full LCM deliverables for the global markets.
  • Must have experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
  • 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 assessment of post approval CMC changes considering global regulatory requirements.

About This Role

This is an exciting opportunity to contribute to the success of our regulatory affairs function. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.

  • Regulatory Affairs Professional

    6 days ago

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

    Job Title: Regulatory Affairs SpecialistWe are seeking a skilled Regulatory Affairs professional to join our team.This role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines).Key Responsibilities:Prepare,...

  • Senior Regulatory Affairs Professional

    3 hours ago

    Amrāvati, Maharashtra, India beBeeCompliance Full time ₹ 1,20,00,000 - ₹ 1,50,00,000

    Compliance Specialist: Senior Compliance Manager is responsible for ensuring adherence to regulatory requirements and maintaining the highest standards of compliance across our organization.Regulatory Expertise: A deep understanding of SEBI, FEMA, and RBI regulations is essential in this role. The ideal candidate will have a strong analytical mindset and...

  • Life Sciences Regulatory Expert

    4 days ago

    Amrāvati, Maharashtra, India beBeeRegulatory Full time US$ 85,000 - US$ 1,10,000

    Job Description The Data Solutions Coordinator role is a critical position within the Regulatory Intelligence team. You will play a key part in monitoring and analyzing the global regulatory landscape within the life sciences industry.Responsibilities include:Actively participate in global regulatory intelligence activities, including monitoring, acquiring,...

  • Senior Food Regulatory Compliance Specialist

    4 days ago

    Amrāvati, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

    We are seeking a seasoned Regulatory Expert to lead our efforts in international food regulations.The ideal candidate will have extensive knowledge of global regulatory standards and the ability to stay up-to-date on the latest developments.This is a unique opportunity to join a pioneering organization at the forefront of digitization and compliance in the...

  • Quality Regulatory Compliance Professional

    5 days ago

    Amrāvati, Maharashtra, India beBeeRegulatory Full time ₹ 23,59,385 - ₹ 30,19,713

    Key Positions: Executive – Quality Assurance and Regulatory AffairsWe are seeking an experienced professional to oversee quality systems and regulatory frameworks for medical devices.Responsibilities:Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.Coordinate regulatory submissions, risk management, and post-market surveillance for...

  • Strategic Corporate Affairs Director

    2 days ago

    Amrāvati, Maharashtra, India beBeeCorporate Full time ₹ 1,50,00,000 - ₹ 2,20,00,000

    **Job Description:**As a seasoned corporate affairs expert, you will be responsible for navigating the complex landscape of government relationships and stakeholder engagement. Your role will involve leading regular interactions with government officials, ensuring favorable policy environments for operations, and monitoring compliance with regulatory...

  • Regulatory Risk Manager

    3 hours ago

    Amrāvati, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

    Job TitleSenior Compliance Analyst/Team Lead/AM/ManagerRole OverviewThe firm seeks a detail-oriented and proactive individual to fill the position of Senior Compliance Analyst/Team Lead/AM/Manager. This role plays a crucial part in ensuring that the firm's trading activities and internal practices comply with regulatory standards and internal policies.Main...

  • Head of Academic and Administrative Affairs

    2 days ago

    Amrāvati, Maharashtra, India beBeeLeader Full time ₹ 18,00,000 - ₹ 25,00,000

    Job Title: Head of Academic and Administrative AffairsThe incumbent will be the chief academic and administrative officer, responsible for providing strategic leadership, ensuring academic excellence, maintaining discipline, and fostering holistic student development.Strategic Leadership: Provide visionary guidance in curriculum development, teaching...

  • Real Estate Regulatory Affairs Expert

    4 days ago

    Amrāvati, Maharashtra, India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 15,00,000

    Legal Compliance SpecialistThe Legal Compliance Specialist will be responsible for overseeing the legal compliance of real estate projects across multiple states in India. This role requires a deep understanding of RERA laws and regulations, as well as excellent coordination and communication skills.Key Responsibilities:Handle end-to-end registration of new...

  • Risk Management Specialist

    6 days ago

    Amrāvati, Maharashtra, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job Summary:A Risk Management Specialist is needed to oversee regulatory compliance across the organization, ensuring adherence to laws and regulations.Key ResponsibilitiesStay up-to-date with regulatory changes affecting our business.Evaluate the impact of these changes on company policies and processes.Communicate updates promptly to senior management for...