Regulatory Operations Assoc Dir

Northbrook, Illinois

Posted in Pharmaceuticals

Job Info

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 at 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

This position is based in Northbrook (Illinois, USA), Leiden (The Netherlands) or Tokyo (Japan). Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

Regulatory Operations - a group within the Regulatory Affairs Department - consists of three areas: Publishing and Submission, Regulatory Product Information Management, and Data Integration and Optimization (DIO).

This position is part of Regulatory Operations of Data Integration and Optimization. The DIO Associate Director is expected to be an expert in this area and should have substantial knowledge of the other two Regulatory Operations areas and how they relate to one another, how our Regulatory systems interact, and how they interface with other aspects of the Astellas' information ecosystem.

Responsibilities involve organizing underlying informatics aspects of projects/products, including the data elements used in submission planning among different systems, registration management and both document- and data-centric submissions to regulatory agencies and establishing relationships with key personnel within the global Regulatory Affairs organization to identify process improvements.

This position also involves the following aspects:

* 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, capable of representing all of Regulatory Operations.
* Proactively resolves complex and diverse business problems with decision-making that impacts area of responsibility and Regulatory Operations as a whole
* Manages one's own tasks and deliverables in alignment with his or her line manager

Essential Job Responsibilities:

* Contributes to Regulatory Operations strategy by implementing actionable plans for near- and long-term process improvements involving RA systems as well as interactions with other functions such as Supply Chain, Pharmaceutical Technology or Pharmacovigilance.
* Leads or participates in cross-functional initiatives involving regulatory information, with particular emphasis on integrations with systems outside of RA, 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
* Tracks alignment of operating models across all concerned RA functional departments (Therapeutic Areas, Affiliates, CMC, Regulatory Intelligence, CCDS & Labeling, Regulatory Operations, Planning and Administration, Compliance and AdPromo groups) during vendor/system selection activities, while preparing for new/major system implementations, and when evaluating ongoing process improvement opportunities in steady state


* Interacts cross-functionally with all concerned RA functional groups (Therapeutic Areas, Affiliates, CMC RA, Regulatory Intelligence, CCDS & Labeling, Regulatory Operations, Planning and Administration, Compliance and AdPromo groups) at all levels in the RA organization.


* The position requires collaboration to ensure consistency in interactions with multiple regional health authorities and other Astellas functions such as Pharmacovigilance, Marketing Operations, Data Science, Supply Chain, Manufacturing and other areas within Medical & Development. The Associate Director also leads or otherwise participates in significant and complex project teams/task forces.
* Liaises with Information Systems and other Planning and Administrative functions on a variety of topics.
* May interact with one or more industry working groups/subgroups such as IRISS or EFPIA.

Quantitative Dimensions:

* Associate Director level staff are expected to provide input on external staffing needs and costs but are not typically accountable for an operating budget.
* Associate Directors in the Publishing & Submission group may be accountable for up to 15-20 products covering countries within multiple geographic regions.
* Globally the Publishing & Submission group supports approximately 2,500-3,000 submissions in approximately 100 countries.
* Globally the Regulatory Product Information Management group supports approximately 3,000-3,500 requests of data entry for Regulatory Information Management system.

Organizational Context:

* Reports to the Director of RA Data Integration and Optimization, currently in the Netherlands.
* Peers are other global Regulatory Operations staff in US, Tokyo and Leiden to promote sense of one Reg Ops team.
* Reg Ops staff are expected to be flexible and willing to work on assignments in any of the three Reg Ops areas based on ability and business need.
* Globally the Reg Ops group has approximately 30 internal staff members which is supplemented by a small number of vendors providing the service-based equivalent of another 20-30 FTE.
* Associate Director level staff are expected to provide input on external staffing needs and costs but are not typically accountable for an operating budget.
* Working location will be the regional headquarters of the residing country. Occasional travel to relevant conferences or team members in other regions.
* Due to the global nature of the position, availability for early morning meetings (in USA) or late- night meetings (in JP) is required.



* 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 within other functions in M&D (eg Development, Pharmacovigilance or Quality Assurance) 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
* 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


* 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
* Proven experience with Lean/Six Sigma
* Experience in defining or interacting with information taxonomies, master data management or other structured data constructs
* Working knowledge of industry standards (such as IDMP, eCTD) and standards bodies (such as ISO, ICH)
* 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


* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Referral bonus program


Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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