Career Category

Job Description

The Global Submission and Information Management (GSIM) team designs and implements process improvements, digital technologies, data standards, training, and organizational change management to deliver business results

The Regulatory Data & Systems Senior Manager is a key position responsible for executing the strategic vision of our regulatory technology landscape. This role involves leading a team, providing subject matter expertise, and collaborating with stakeholders to help drive innovation and efficiency in regulatory affairs. The Senior Manager will also be responsible for helping to deliver continuous improvement to enterprise regulatory systems, streamlining data models, and influencing vendor partnerships to ensure regulatory compliance and deliver measurable business results.

Roles & Responsibilities:

• Leadership: Execute the strategic roadmap for regulatory information systems, aligning technology initiatives with organizational goals and regulatory compliance requirements.

• Subject Matter Expertise: Serve as an in-house subject matter expert (SME) on regulatory information management, keeping abreast of evolving regulatory landscapes and technology trends.

• System Process Simplification: Identify opportunities to simplify and streamline system-based processes and user interfaces

• Team Leadership: Lead a team of professionals responsible for the implementation, maintenance, and continuous improvement of regulatory information systems and data management processes.

• Vendor Management: Collaborate with external vendors and technology partners to optimize system capabilities and influence product roadmaps to meet organizational needs.

• Data Model Expertise: Serve as a data model expert with a focus on IDMP, ensuring that the organization's regulatory information aligns with evolving data standards and requirements

• Enterprise User Base Support: Provide guidance, training, and support to a large user base, ensuring successful utilization of regulatory information systems.

• Compliance Assurance: Ensure that all regulatory information systems and adhere to relevant regulatory requirements, standards, and data security protocols.

Required Knowledge and Skills:

• Leadership: Execute the strategic roadmap for regulatory information systems, aligning technology initiatives with organizational goals and regulatory compliance requirements.
• Subject Matter Expertise: Serve as an in-house subject matter expert (SME) on regulatory information management, keeping abreast of evolving regulatory landscapes and technology trends.
• System Process Simplification: Identify opportunities to simplify and streamline system-based processes and user interfaces
• Team Leadership: Lead a team of professionals responsible for the implementation, maintenance, and continuous improvement of regulatory information systems and data management processes.
• Vendor Management: Collaborate with external vendors and technology partners to optimize system capabilities and influence product roadmaps to meet organizational needs.
• Data Model Expertise: Serve as a data model expert with a focus on IDMP, ensuring that the organization's regulatory information aligns with evolving data standards and requirements
• Enterprise User Base Support: Provide guidance, training, and support to a large user base, ensuring successful utilization of regulatory information systems.
• Compliance Assurance: Ensure that all regulatory information systems and adhere to relevant regulatory requirements, standards, and data security protocols.
   

Preferred Knowledge and Skills:

• Advanced knowledge of Enterprise Information management systems such ERP, QMS, & Change Management,  
• Familiarity with global regulatory requirements and standards beyond the organization's primary market.
• Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment.

Basic Education and Experience:

• Doctorate degree and 8 years of regulatory systems experience OR
• Master’s degree and 10 years of regulatory systems experience OR
• Bachelor’s degree and 12 years of regulatory systems experience OR

Preferred Education and Experience:

• Experience with regulatory documents in Regulatory Affairs, Research, Development, Quality Management, or related area
• 5+ years’ experience in implementing large scale enterprise systems in the Biotech/Pharmaceutical industry