Regulatory Executive

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: ₹200,000.00 - ₹400,000.00 per year

Benefits:

• Paid sick time
• Paid time off
• Provident Fund

Experience:

• Dossier Preparation: 1 year (Preferred)
• ROW Market: 1 year (Preferred)

Work Location: In person