Astellas Pharma Regulatory Operations Associate Director in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Regulatory Operations Associate Director opportunity in Northbrook, IL.
Position & Scope:
· This job description applies within Regulatory Operations of Data Integration and Optimization. The Associate Director is expected to be an expert in this area and should have substantial knowledge of other 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 regulatory operations aspects of projects/products, including managing the planning, preparation, submission and tracking of correspondence, applications and other structured data to regulatory agencies; identifying and ensuring adherence to relevant submission standards; and establishing relationships with key personnel within the global Regulatory Affairs 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 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.
Essential Job Responsibilities:
Common Regulatory Operations responsibilities at this level
· Incorporates industry specifications/initiatives into our processes and deliverables
· Trains other staff members on systems and processes; identifies training needs based on individual performance, evolving team responsibilities and/or industry developments
· 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
· Provides detailed interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact products and operations; identifies short- and long-term strategies to implement relevant changes in system configurations and business processes to maximize efficiency and/or improve compliance
· May be responsible for business system support tasks for key RA systems including user and functional requirement definition, end user testing and technical infrastructure requirements
· May manage internal staff and/or external resources including temporary staff and outsourced services, commonly but not necessarily in one geographic area; develops team by recruiting, coaching, assessing and guiding staff members
· Mentors junior staff members on proximate/regional regulatory processes, systems and standards
· Manages one's own tasks and deliverables in alignment with his or her line manager
Data Integration and Optimization
· Contributes to Regulatory Operations strategy by implementing actionable plans for near- and long- process improvements involving RA systems as well as interactions with other functions such as supply chain, Pharm Tech or Pharmacovigilance
· 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, including disaster recovery and business continuity planning
· 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
· 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 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
- 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
- Reports to a Director or Sr. Director of Regulatory Operations
- Primary assignment will be within one of the three Regulatory Operations groups
- Line manager may be in another geographic location
- May have line management responsibility, within the same office location where possible
- Peers are other global Regulatory Operations staff 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 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
- 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
- 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
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Regulatory Affairs