Manager, Regulatory Compliance Specialist

7 days ago


Hyderabad, Telangana, India Bristol Myers Squibb Full time
About the Role

This position plays a vital role in ensuring compliance with global regulatory requirements and pharmacovigilance guidelines. As a Manager of Regulatory Compliance, you will oversee quality, compliance, and inspection readiness activities within the Worldwide Patient Safety group.

Key Responsibilities
  • Oversight of compliance monitoring programs and processes to ensure continuous compliance with all applicable safety guidelines and regulations.
  • Collaboration with local and global compliance and quality leads for continuous compliance improvement through ongoing communications regarding quality trends and process reinforcement.
  • Contribution to WWPS inspections and audits, both proactively and post-evaluation, to ensure implementation of corrective and preventative actions within areas of expertise.
Requirements

A minimum of 5 years of pharmaceutical industry experience, including 3 years of pharmacovigilance, drug development, clinical development, or regulatory affairs experience specifically involving Safety Database case processing.

Prior experience in IT project management, including skills for JIRA management, HP ALM, and SharePoint management, is preferred.

Strong scientific background in a life science-related field and prior quality-related experience in pharmacovigilance are also highly valued.

Salary Range

The estimated salary for this position is between $120,000 and $180,000 per annum, based on industry standards and the level of experience required.

Benefits and Culture

Bristol Myers Squibb offers a comprehensive benefits package, including competitive pay, stock options, and retirement savings plans. The company values diversity, inclusion, and employee well-being, providing opportunities for professional growth and development.



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