Team Lead, RAPV Data Governance and Compliance

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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
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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.

Qualifications

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

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

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