Regulatory Executive

2 weeks ago

Mumbai, Maharashtra, India Fiza Healthcare Pvt Ltd Full time ₹ 3,00,000 - ₹ 4,00,000 per year

Key Responsibilities:

  • Regulatory Compliance & Monitoring:
  • Ensure that the company's products comply with the regulatory requirements of the regions in which they are distributed.
  • Stay current with national and international legislation, guidelines, and customer practices.
  • Regulatory Submissions & Documentation:
  • Prepare and submit regulatory dossiers, documents, and samples for participation in tenders, adhering to market-specific requirements.
  • Collect, collate, and evaluate scientific data from various sources, preparing dossiers in CTD/ACTD formats as per market demands.
  • Product Registration & Approvals:
  • Monitor timelines for registration, variations, renewal approvals, and submissions to ensure timely completion.
  • Follow up with the marketing team to ensure marketing authorization, registration data, and status are up-to-date.
  • Labeling & Documentation:
  • Write clear, accessible product labels and patient information leaflets to comply with regulatory standards.
  • Strategic & Advisory Role:
  • Provide strategic regulatory advice to senior management during new product development.
  • Advise country sales managers on regulatory requirements to ensure market compliance.
  • Team Management & Collaboration:
  • Lead and manage teams of colleagues involved in the development of new products, ensuring adherence to regulatory processes.
  • Work closely with cross-functional teams, including marketing, legal, and R&D, to ensure compliance.
  • Regulatory Audits & System Review:
  • Undertake and manage internal regulatory audits to ensure compliance with internal and external standards.
  • Review company practices and advise on necessary changes to systems and procedures to align with regulatory requirements.
  • Stakeholder Liaison:
  • Liaise with regulatory authorities and stakeholders, including making presentations and participating in meetings as needed.
  • Packaging & Advertising Approvals:
  • Participate in the development of marketing concepts and approve packaging and advertising materials prior to product release to ensure they comply with regulatory standards.

Job Type: Full-time

Pay: ₹300, ₹400,000.00 per year

Benefits:

  • Paid sick time
  • Paid time off
  • Provident Fund

Work Location: In person

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