Regulatory Affairs Specialist

2 days ago

Pune, Maharashtra, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Compliance Manager

The Compliance Manager plays a pivotal role in ensuring that our organization adheres to regulatory standards and maintains a culture of ethics and trust.

  • Draft and review policies aligned with regulatory and organizational requirements.
  • Design and deliver compliance training programs across business units, promoting awareness and understanding of relevant regulations.
  • Maintain accurate audit trails of documentation related to the TPO framework, policies, and training (internal and external).
  • Conduct risk-based reviews and present findings to leadership, identifying areas for improvement.
  • Collaborate with cross-functional teams to foster a culture of ethics and compliance, promoting transparency and accountability.
  • Support the deployment of AI-based applications in compliance monitoring, ensuring alignment with DPDP regulations.
  • Ensure adherence to pharma-specific regulations, including UCPMP guidelines and NMC regulations.
  • Conduct field reviews to assess compliance and operational integrity, addressing any deviations or issues.
  • Monitor regulatory changes and update internal frameworks accordingly, staying informed on evolving requirements.
  • Assist in internal investigations and reporting of compliance breaches, taking corrective action as necessary.
  • Develop dashboards and reports for compliance metrics and insights, providing valuable information to stakeholders.

Key Responsibilities:

  • Review and implement policies aligned with industry regulations and organizational goals.
  • Develop and deliver comprehensive compliance training programs.
  • Manage and maintain accurate records of all compliance-related documentation.
  • Perform regular risk assessments and provide recommendations for improvement.
  • Collaborate with various departments to promote a culture of ethics and compliance.
  • Support the integration of AI technology into compliance monitoring processes.
  • Ensure adherence to industry-specific regulations and guidelines.
  • Conduct thorough reviews of compliance and operational practices.
  • Stay up-to-date on regulatory changes and updates internal frameworks accordingly.
  • Lead internal investigations and report compliance breaches.
  • Provide valuable insights and data through compliance metrics and dashboards.

Qualifications and Experience:

  • Postgraduate degree in Law, Business Administration, or a related field is preferred.
  • Minimum 8-10 years of experience in compliance, corporate governance, or a related field.
  • Strong understanding of pharmaceutical regulations, including UCPMP and NMC.
  • Experience in risk assessment, reporting, and internal investigations.
  • Familiarity with AI tools and data protection regulations.
  • Excellent communication, analytical, and collaboration skills.
  • Ability to manage multiple stakeholders and drive cross-functional initiatives.
  • Prior experience in implementing ethics and compliance programs in pharma or healthcare settings is an advantage.
  • Proficiency in preparing compliance dashboards and reports.
  • Certification in compliance, ethics, or data privacy is an added advantage.
  • Experience working with international regulatory frameworks and cross-border compliance issues.
  • Strong project management skills and ability to lead initiatives independently.

This role requires a deep understanding of regulatory requirements, strong analytical skills, and excellent communication abilities. The ideal candidate will have a proven track record in compliance and be able to drive positive change within our organization.

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