Partner, RA Data Governance

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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
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at www.astellas.com
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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 Partner RA Data Governance should know how the Regulatory systems interact,
and how they interface with other aspects of the Astellas information ecosystem.
Responsibilities involve identifying and ensuring adherence to relevant data
standards; and establishing relationships with key personnel within the global
RAPV organization to identify process improvements. The position also requires
collaboration to ensure consistency in interactions with multiple regional
health authorities and other Astellas functions such as Marketing Operations,
Data Science, Supply Chain, Manufacturing and other relevant areas across
Astellas. The Partner RA Data Governance also leads or otherwise participates in
significant and complex project teams/task forces.

Responsibilities and Accountabilities:

* Incorporates industry specifications/initiatives into our processes and
deliverables
* Contributes to and sometimes leads cross-functional and/or industry
initiatives including IT system

implementations and process re-engineering projects

* Contributes to RAPV strategy by implementing actionable plans for near- and
long- process improvements involving RAPV systems as well as interactions
with other functions such as supply chain, or Pharm Tech.
* Monitors the availability of and identifies ways to leverage opportunities
provided by evolving Artificial Intelligence and other advanced digital
capabilities
* Ensures compliance in processes and systems with both internal and external
procedure and guidelines/legislation
* Tracks alignment of operating models across all concerned RAPV functional
departments during vendor/system selection activities, while preparing for
new/major system implementations, and evaluating ongoing process improvement
opportunities in steady-state
* Implements methods to evaluate processes and standards against Key
Performance Indicators, leveraging methodologies such as Lean Six Sigma where
applicable
* Leads or participates in cross-functional initiatives involving regulatory
information, with particular emphasis on integrations with systems outside of
RAPV, shared information taxonomies and data dictionaries
* Leads or participates in industry working groups to represent Astellas, often
in collaboration with other RA members including Regulatory Intelligence
colleagues, spanning information needs for all RA functional departments
* Liaises with Information Systems and other Planning and Administrative
functions on a variety of topics including platform strategies and IT roadmap
prioritization

Qualifications

Required Qualifications:

* Bachelor’s degree (science or technology is preferred)
* At least seven years’ experience in a regulatory operations role or similar
position associated with regulated processes and content in the pharma
industry
* Demonstrated accomplishments and/or education will be evaluated and
substituted for extent of experience, as needed
* Proven ability to coordinate priorities and tasks across project teams,
committees, etc. to attain group objectives
* Proven ability to anticipate and proactively resolve project or procedural
issues
* Demonstrated experience championing new processes and leading change
management activities
* If managing staff, the incumbent should have experience managing people
and/or teams or otherwise demonstrate the ability to do so
* Strong ability to communicate effectively in writing and verbally in English
* Ability to multi-task across multiple projects and deliverables
* High integrity to maintain confidential and proprietary information
* Ability to keep calm under pressure

Preferred Qualifications:

* Advanced degree (e.g., Masters, PhD, etc.)
* 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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