Senior Manager GRAAS Operations

Amgen; Hyderabad; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Amgen is seeking a Senior Leader for Regulatory Submission and Information Management (GSIM) to drive the strategic roadmap for regulatory information systems and serve as the in-house SME on regulatory information management.

You will lead a team to implement, maintain, and continuously improve data management processes and ensure compliance with evolving regulatory standards.

Qualifications

• Experience leading regulatory information systems in biotech/pharma.
• Deep knowledge of regulatory landscapes and data standards.
• Experience implementing large-scale enterprise systems.

Responsibilities

• Lead the strategic roadmap for regulatory information systems and ensure alignment with regulatory requirements.
• Act as SME on regulatory information management and data standards such as IDMP.
• Identify and simplify system-based processes and user interfaces to improve adoption.
• Lead a team responsible for implementation, maintenance, and continuous improvement of regulatory information systems and data management processes.
• Collaborate with vendors and technology partners to optimize system capabilities and influence product roadmaps.
• Ensure enterprise-wide user support and training for regulatory information systems.
• Ensure compliance with relevant regulatory requirements, standards, and data security protocols.

Skills

Leadership

Subject matter expert

System process simplification

Team leadership

Vendor management

Data model expertise (IDMP)

Enterprise user support

Compliance assurance

Education

Doctorate + 8 years

Master’s + 10 years

Bachelor’s + 12 years

Tools

ERP

QMS

Change management

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.

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