Senior Manager GRAAS Operations

Amgen Inc; Hyderabad; On-site; INR 3,500,000 - 6,500,000; Full time

Job summary

Amgen Inc in Hyderabad seeks a Regulatory Data Systems Senior Manager to drive the strategic vision for regulatory technology, lead a team, and partner with stakeholders to improve enterprise systems and data models. You will influence vendor roadmaps and ensure regulatory compliance while delivering measurable business results.

The role emphasizes data standards, IDMP alignment, and enterprise-wide user support in a dynamic Biotech environment with Agile practices.

Qualifications

• Experience leading regulatory information systems programs.
• Strong knowledge of regulatory information management and data standards.
• Familiarity with IDMP and regulatory data models.

Responsibilities

• Lead the strategic roadmap for regulatory information systems.
• Serve as SME on regulatory information management and technology trends.
• Identify opportunities to simplify system-based processes and interfaces.
• Direct a team responsible for implementation and improvement of regulatory info systems.
• Collaborate with vendors to optimize capabilities and roadmaps.
• Ensure alignment with evolving regulatory data standards.

Skills

Leadership

Subject Matter Expertise

System Process Simplification

Team Leadership

Vendor Management

Data Model Expertise

Enterprise User Base Support

Compliance Assurance

Education

Doctorate degree

Masters degree

Bachelors degree

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

• Masters degree and 10 years of regulatory systems experience OR

• Bachelors 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