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Astellas is announcing a Regulatory Affairs Manager (Urology), Location, Northbrook, IL
Purpose & Scope:
Responsible for the successful development of regulatory strategies, plans and processes for assigned projects and/or products. The assigned area responsibility may be focused on global and/or regional development compounds and new indications / formulations of commercial products and/or life cycle management of commercial products within a within a region.
• May be responsible as a regional regulatory lead for development programs, or as a regulatory representative for commercial products. May participate on extended regulatory teams and support a global regulatory lead.
• Collaborates to assure local regulatory strategies reflect scientific, therapeutic and regulatory expertise and knowledge and ensures Astellas' programs meet all applicable regulatory and business requirements. Provides regional input and ensures regional alignment with regulatory strategies for global programs and products.
• Responsible for interacting with global and regional peers and regulatory management to align Astellas' regulatory strategies; contributes to project/product decision making ensuring viable regulatory approaches, and may interact with regulatory agencies.
• Under supervision, communicates and interacts with project and/or product team members, regulatory authorities and health agencies and incorporates regulatory environment trends to ensure the projects/products reflect up-to-date regulatory strategies.
Essential Job Responsibilities:
• Under supervision, contributes to the development, implementation and successful application of regulatory strategy input to assigned areas for submissions such as MAA, NDA and variations associated with development programs and/or commercial products, and reviews major deliverables from a regulatory perspective.
• Under supervision, contributes to regulatory development in the context of Development TAs and Core Teams and Regulatory Extended Teams for programs.
• Applies understanding of regulatory requirements and trends.
• Contributes to the successful adoption and execution of appropriate regulatory strategies and processes, which ensure project and/or product programs meet established timelines and are aligned with Astellas' short and long-term business strategies and goals.
• Under supervision, responsible for the preparation and submission of technical documents to regulatory authorities for assigned projects/products. Reviews data summaries from research, development, and manufacturing reports for adequacy in content, quality, interpretation and regulatory/scientific rigor. Under supervision, responsible for execution of the regulatory strategy into regulatory applications (i.e. Scientific Advice, IND, MAA, NDA, BLA and variations) across assigned development projects and/or commercial products.
• Participates in Extended GRA team, or contributes to activities of Global or Regional Regulatory Leads or other GRA staff in a matrix organization on regulatory and decision making issues. Shares relevant information and identifies and escalates where appropriate to resolve significant issues and risks.
• Monitors regulatory developments, guidelines, and industry trends, particularly with respect to assigned projects/products, and contributes to the preparation of recommendations and robust opinions for management in a timely manner.
• Under supervision, interprets, identifies, recommends, and advises project/program teams on regulatory guidelines and risk matters and contributes to the development and implementation of plans to address regulatory and/or product issues.
• May provide regulatory advice to ad hoc teams/task forces set up for process improvements, alignment with new regulatory requirements or business initiatives on behalf of GRA.
• Contributes to the strategy for interaction with Health Authorities or business partners for the assigned projects/products.
Organization & People Management:
• Supports an environment to enable each member of the Regulatory Affairs team to optimally operate in the matrix environment of GRA, Global Medical Development, Technology/PPM and Astellas (e,g, GMS, regional commercial businesses, Medical Affairs, Legal, affiliates, etc).
• May represent GRA within regional project/product teams
• Input into regional project development and life cycle management strategies will have a significant impact on the company's success including sales and risk management.
• Failure to perform functions could have substantial implications on operations, sales, revenue, and/or credibility of Astellas
• Indirect impact on the development strategy for projects with the assigned area.
• Direct impact (<$2 million) on the successful registration of new products, indications, line extensions and/or on the revenue generation from a given product (range).
• Position reports to a GRA TA Head, Regional Head, Group Lead or Team Lead Development and/or Life Cycle Management.
• Peers to this position include peer GRA staff, peers across functions within GMD and those participating in the regional project team, a region, Technology/PPM staff and representatives of commercial organizations.
• Bachelors; science degree required.
• 4-5 years in a discipline associated with pharmaceutical development or product oversight; 2-3 years in regulatory affairs preferred.
• Scientific knowledge and regulatory experience applicable to the role. Solid basis in scientific approach, an ability to deal with technical information from a variety of disciplines.
• Good technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and including knowledge of regulatory requirements and ICH guidances.
• Good interpersonal, verbal and written communication skills.
• Good verbal and written communication skills
• Strong analytical and problem solving skills
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled