Senior Manager - Regulatory Data Management

Senior Manager of Regulatory Data Management

Roles & Responsibilities

• Build and lead an impactful team, focused on delivering global

  regulatory data management services

  within the regulatory information management system.
• Develop a collaborative and inclusive team culture that promotes innovation and continuous improvement.
• Ensure the team meets

  key operational metrics and compliance standards

  , maintaining high levels of accuracy and efficiency.
• Drive continuous improvement initiatives to enhance service delivery and operational processes.
• Minimize potential errors by establishing policies & processes for data usage.
• Supervise the provision of

  high-quality data processing, system utilization, and data management services

  to global clients.
• Develop and implement comprehensive training programs to ensure team members are skilled and knowledgeable in regulatory data management practices.
• Stay abreast of

  regulatory developments

  and ensure the team follows all relevant regulations and standards.

What We Expect of You

Basic Qualifications

• Doctorate degree and 2 years of regulatory systems experience

  OR

• Master's degree and 8 to 10 years of regulatory systems experience

  OR

• Bachelor's degree and 10 to 14 years of regulatory systems experience

  OR

• Diploma and 14 to 18 years of regulatory systems experience

• Advanced knowledge of Veeva Vault RIM

  .
• Proven leadership in

  regulatory data management

  .
• Hands-on ability to work on

  data-centric processes and systems

  .
• Strong knowledge of handling structured and unstructured data.
• Demonstrated excellence in

  change management and key customer engagement

  .

Preferred Qualifications

• Experience with delivering

  compliance assurance

  within a large company.
• Experience with large-scale

  enterprise systems in the Biotech/Pharmaceutical industry

  .
• 5 years of proven experience in

  regulatory operations, submission management

  .
• Excellent understanding of

  Regulatory Affairs business complexity and process interdependencies

  .
• Experience with regulatory data in Regulatory Affairs, Research, Development, Quality Management, or related area.
• Demonstrated experience in

  building and leading successful teams

  .
• Sharp learning agility and analytical thinking.
• Proven and advanced interaction with global key customers.