Team Lead RAPV Data Governance and Compliance

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong to Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

Astellas' Global Capability Centers - Overview

Astellas' Global Capability Centers (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are in India, Poland and Mexico.

The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.

Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company's strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

This position is based in Bengaluru and will require some on-site work.

Purpose and Scope:

• The Lead is expected to have extensive experience and provide thought leadership in Data Governance and Compliance, as well as on how the regulatory systems, processes, and data interact and interface with other aspects of the Astellas information ecosystem.
• Responsibilities involve leading and enabling regulatory operations activities supporting all types of product offerings. This includes planning, preparation, submission, and tracking of submission packages, correspondence, and structured data to regulatory agencies. It also includes interpreting and ensuring adherence to internal and external procedures, regulations, and relevant submission and data standards.

Additionally, the role involves establishing unambiguous and reliable source data and systems and harmonizing tools and processes where possible. The Lead will monitor and influence the regulatory environment while identifying future business needs related to industry initiatives, agency requirements, and internal organizational changes.

The position also requires establishing strong relationships with key vendors and with key personnel within the global Regulatory Affairs organization to champion the adoption of new systems and process improvements.

Responsibilities and Accountabilities:

Common Regulatory Operations Responsibilities

• Contributes to and executes against the RAPV strategy by creating 1-3 year plans for the RA system and process capabilities, aligning their group with the other RAPV Enablement groups, considering industry initiatives, Health Authority guidances, software vendor capabilities, corporate strategy, internal RA process improvements, system interactions with other functions and end user input.
• Ensures alignment of operating models and use of RA systems across all concerned RA functional departments during vendor/system selection activities, while preparing for new/major system implementations, and when evaluating ongoing process improvement opportunities in steady-state
• Is accountable for the measurement and evaluation of process effectiveness, vendor service delivery and standards with Key Performance Indicators, and introduces and maintains best practices leveraging methodologies such as Lean Six Sigma
• Manages and Leads staff and consultants as well as mentors junior staff members on regulatory processes, develops team through successful recruitment, performance management and by identifying professional growth opportunities for internal staff members
• Champions and sometimes leads cross-functional and/or industry initiatives including IT system implementations and process re-engineering projects, capable of representing all of Regulatory Operations
• Is accountable for resolving complex business problems with decision-making under time pressure, that impacts area of responsibility and Regulatory Operations as a whole
• Identifies the need for and ensures the assimilation of detailed interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact products and operations; prioritizes short- and long-term projects to implement relevant changes in system configurations and business processes to maximize efficiency and/or improve compliance
• Is accountable for compliance in processes and systems with both internal and external procedures and guidelines/legislation
• Collaborates with the RA Vendor Management team to strive for optimal external resource utilization and oversight, and manages vendor relationships for services used to support their group
• Participates in and sometimes leads industry working groups to represent Astellas, often in collaboration with other RA members including Regulatory Intelligence colleagues

Data Governance and Compliance Specific Responsibilities

• Responsible for monitoring internal and external data standards for Regulatory Affairs and safeguard their interoperability within RA and with other functions
• Accountable for the RA data blueprint, including regulatory data lineage and its implementation in RA processes and systems
• Accountable for data consistency within Regulatory Affairs and with other functions
• Sponsors, leads or participates in cross-functional initiatives involving regulatory information, with particular emphasis on integrations with systems outside of Regulatory Affairs, shared information taxonomies and data dictionaries
• Serves as escalation point for regulatory data stewardship and regulatory data ownership issues
• Aligns RA functions and systems on appropriate usage of data assets across RA for all RA systems to support the submissions and data entry in line with enterprise-wide Data Governance and Data Integrity committees
• Responsible for directing and leading the development of RA metrics and data analysis standards for compliance oversight, strategic insights, and management reporting
• Responsible for optimization of performance of the Regulatory Affairs' activities driven by CAPAs
• Ensure accuracy and on-time completion of data governance, metrics and reporting initiatives
• Ensures oversight of compliance of RA functions to Quality Documents and agreed regulatory action plans for Affiliate functions
• Ensure coordination of RA's involvement in audits and inspections.