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.
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 and pharmacovigilance (safety) 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.
- The role additionally provides global leadership for pharmacovigilance (PV) data governance to ensure safety data and related master/reference data are reliable, compliant, and interoperable with Regulatory Affairs (RA) and enterprise data assets to support regulatory reporting, safety surveillance, and inspection readiness.
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 and safety reporting 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 RAPV organization to champion the adoption of new systems and process improvements and to drive harmonized governance, controls, and sustainable operational models across RA and PV.
Responsibilities and Accountabilities:
- Ensures strategic alignment of RA and PV data capabilities and interoperability across shared data domains.
- Ensures alignment of operating models and use of RAPV systems across RAPV functions during vendor/system selection activities, while contributing to new/major system implementations, and when evaluating ongoing process improvement opportunities in steady-state.
- Establishes data quality and governance KPIs for RA/PV critical data within scope; 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, and develops the team through successful recruitment, performance management, and by identifying professional growth opportunities for internal staff. Leads a global team responsible for RA and PV data governance and RA compliance oversight
- Champions and sometimes leads cross-functional and/or industry initiatives including IT system implementations and process re-engineering projects, representing RAPV Data Governance and RA Compliance,
- Is accountable for resolving complex business problems with decision-making under time pressure, that impacts area of responsibility
• 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• Is accountable for RA compliance in processes and systems with both internal and external procedures and guidelines/legislation; ensures governance controls support compliance for RA processes and systems and PV data domains within scope.
- Collaborates with the RA Vendor Management team to strive for optimal external resource utilization and oversight
- Participates in and sometimes leads industry working groups to represent Astellas, often in collaboration with other RAPV members including Regulatory Intelligence colleagues.
- • Responsible for monitoring internal and external data standards for Regulatory Affairs and Pharmacovigilance , safeguarding interoperability within RA and PV and with other functions (E2B(R3), eCTD4, ISO IDMP, EMA SPOR....).
- Accountable for the RAPV data blueprint, including data lineage and its implementation in RAPV processes and systems.
- Accountable for data consistency within RAPV and with other functions including shared master/reference data and reporting-critical attributes used across regulatory submissions and PV reporting/surveillance.
- Sponsors, leads, or participates in cross-functional initiatives involving regulatory and safety information, with particular emphasis on integrations outside RAPV, shared information taxonomies, and data dictionaries; ensures consistent definitions, ownership, and controlled changes.
- Serves as escalation point for RA and PV data stewardship and ownership issues within scope; brokers decisions on data definitions, ownership, and controls with key stakeholders.
- Aligns RA and PV stakeholders on appropriate usage and governance of shared data assets to support both regulatory submissions and safety reporting/surveillance, in line with enterprise Data Governance and Data Integrity committees
- Responsible for directing and leading the development of RA and PV data governance metrics.
- Responsible for optimization of performance of the Regulatory Affairs’ activities driven by NC/CAPAsEnsure 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.
- Ensures coordination of RA involvement in audits and inspections and partners with PV, Quality, and IT to support inspection readiness for RAPV data governance–relevant topics (e.g., data integrity controls, traceability/lineage,) and RA Compliance.
- Establishes and maintains clear data ownership and stewardship for PV data domains within scope, including shared master/reference data and reporting-critical .
Required Qualifications:
- Master degree or equivalent level is strongly recommended (science or technology is preferred)
- At least 10 years’ experience in a (global) regulatory operations role or similar position associated with regulated processes and content in the pharma industry
- At least 6 years’ experience managing people and/or teams in a cross-cultural / global setting
- Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed
- Proven ability to define priorities and tasks across project teams, committees, etc. to attain group objectives
- Demonstrated leadership championing new processes and leading change management activities
- High integrity to maintain confidential and proprietary information
- Experience managing budgets for IT projects and external staffing needs
- Strong communication and collaboration skills
- Strong ability to communicate effectively in English, both writing and verbally in English speaking
Participation in one or more industry groups, demonstrating knowledge of current and upcoming industry trends and initiatives
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Preferred Qualifications:
- PhD degree, preferably in a science or technology field
- Experience with managing IT systems
- Proven expertise in document management, submission publishing, registration management, labeling, quality
control and/or change control systems
- Experience in defining or interacting with information taxonomies, master data management or other
structured data constructs
- Experience with data warehousing, data lakes and reporting/analytics platforms
- Proficiency in other language(s) –most common/useful are Dutch, Japanese, Spanish, Portuguese, French,Russian, Chinese.
- Experience in pharmacovigilance processes and/or safety data management, including safety reporting and compliance expectations
- Experience with PV/safety systems and structured safety data standards/terminologies
- Experience working at the interface of RA and PV data domains (e.g., shared master/reference data governance and reconciliation)
Working Environment
The role operates in a global matrix and partners closely with RA and PV stakeholders across regions, Quality, IT, and external vendors.
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