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Astellas Pharma Asc Development and/or LCM Dir Regulatory Lead IC 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 an Asc Development and/or LCM Dir Regulatory Lead IC opportunity in Northbrook, IL.

Purpose & Scope:

Responsible for the development and successful execution of regulatory strategies, plans and processes for assigned projects and/or products with significant technical complexity and diversity requiring direct impact on internal decision making. The assigned area responsibility may be focussed on global and/or regional development compounds and new indications / formulations of commercial products and/or life cycle management of commercial products within a global GRA TA or within a region. Responsible to be a regulatory lead, which may include Global Regulatory Lead, for advanced, late-stage development programs, or as a regulatory representative for strategic commercial products requiring complex problem solving and internal decision making. Collaborates to assure global and local regulatory strategies reflect best in class application of 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 to support Astellas' strategic goals; influences internally and externally to contribute to project/product decision making ensuring viable regulatory approaches, and plays a primary role in interactions with regulatory agencies.

Accountable for project-related and marketed product-related communications and interactions with project and/or product team members, regulatory authorities, health agencies, key opinion leaders and business partners requiring direct impact on decision making; interprets and incorporates regulatory environment trends to ensure the projects/products reflect the most up-to-date regulatory strategies.

May lead an Extended Regulatory Team including Regional Regulatory Leads and other GRA professionals across regions and functions to develop and implement regulatory strategies and accomplish project/product objectives for global and/or regional products. Monitors the knowledge and expertise of involved regulatory staff and advises project/product teams in the application of regulatory strategies and solving of complex regulatory issues.

Collaborates with Astellas GRA TA Heads and regions on global regulatory strategies and with Astellas functions for regional programs and products.

Essential Job Responsibilities:

Regulatory Excellence:

Leads the development, implementation and successful application of robust regulatory strategy input to assigned areas for large, complex submissions such as MAA, NDA and variations associated with development programs and/or commercial products leveraging deep understanding of scientific and therapeutic area knowledge to teams, which may include Development Core Teams, Extended Regulatory Teams and Core Medical Teams, and is accountable for the expert review of major deliverables from a regulatory perspective. Leads regulatory development in GRL roles in the context of Development TAs and Core Teams and Regulatory Extended Teams for programs of high technical complexity and diversity such as global late stage development for a new molecular entity requiring direct impact on internal and external decision making. Applies in depth understanding of regulatory requirements and trends into the development of aligned regulatory strategies.

Develops and ensures 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.

Accountable for the leadership, oversight and governance of the preparation and submission of complex technical documents to regulatory authorities for assigned projects/products. Ensures data summaries from research, development, and manufacturing reports are adequate in content, quality, interpretation,and regulatory/scientific rigor in order to drive success with regulatory authorities and builds consistency in the messaging of data globally. 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. Assures submissions reflect the best in class application of regulatory standards and Astellas SOPs and are executed on time. Ensures viable strategies are established for regulatory applications.

Collaborates with GRA management to provides oversight on regulatory matters; and where needed, directs the contributions to meetings with regulatory authorities, key opinion leaders and similar experts and bodies.

Guides Extended GRA team members, Regional Regulatory Leads or other GRA staff in a matrix organization on challenging, complex regulatory and decision making issues. Shares relevant information and drives development of viable strategies and/or methodologies which reflect the most up-to-date regulatory and compliance standards. Identifies and escalates where appropriate to resolve significant issues and risks.

Provides regulatory expertise for planning, approving regulatory content and reviews/participates in the evaluation of in-licensing opportunities and due diligence activities.

Monitors regulatory developments, guidelines, and industry trends, particularly with respect to assigned projects/products, and prepares recommendations and robust opinions for management in a timely manner.

Interprets, identifies, recommends, and advises project/program teams and Company on regulatory guidelines and risk matters and is accountable for the development and implementation of plans to address regulatory and/or product issues.

Provides 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. Builds and maintains good relationships with Regulatory Authorities.

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 be responsible for mentoring and training and may supervise GRA staff directly or indirectly. Effectively delegates responsibilities to achieve goals and effectively develops and aligns individuals to the best of their abilities, while ensuring optimal oversight and supervision to ensure goals are achieved and appropriate growth in technical, leadership and team membership skills.

Ensure the alignment between GRA strategy and mid- and long-term Astellas strategy and conformity with Corporate guidelines.

Represents GRA within project/product teams and collaborates with global Astellas stakeholders to affect global strategies and consistency in regulatory messaging.

Quantitative Dimensions:

Input into global and/or regional project development and life cycle management strategies will have a significant impact on the company's success including sales and risk management. Must be able to negotiate the regional position in global forums.

Failure to perform functions could have substantial implications on operations, sales, revenue, and/or credibility of Astellas up to $100 million or more.

Indirect impact on the development strategy for projects with the assigned area. Typical clinical development programs include budgets in excess of $100 million per project.

Direct impact on the successful registration of new products, indications, line extensions. The estimated revenue generation from a given product is between $10-500 million per year per region.

Organizational Context:

Position reports to a GRA TA Head, Regional Head, Group Lead or Team Lead Development and/or Life Cycle Management. May lead an Extended Regulatory Team including Regional Regulatory Leads and other GRA staff for global projects and other GRA staff for regional projects and products.. Peers to this position include peer GRA staff, peers across functions within GMD and those participating in the global project team, a region, Core Medical Team members, Technology/PPM staff and representatives of commercial organizations.

Qualifications:

Required:

  • Bachelor of Science degree; advanced science degree preferred
  • 8 years in a discipline associated with pharmaceutical development or product oversight; 3 years in regulatory affairs preferred.
  • Strong scientific knowledge and regulatory experience applicable to the role. Solid basis in scientific approach, an ability to deal with in-depth technical information from a variety of disciplines and a proven, successful track record of establishing and maintaining a high degree of scientific credibility with regulatory authorities.
  • Proficient technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and including knowledge of regulatory requirements and ICH guidances.
  • Demonstrated successful experience in applying current and evolving regulatory requirements to projects/programs.
  • A proven track record in leading submissions, interactions with regulatory authorities, approvals and complex programs applicable to the responsibility of the specific role.
  • Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders.
  • Excellent verbal and written communication skills
  • Strong analytical and problem solving skills
  • Proven leadership and negotiation skills
  • Roles within a GRA development TA require a proven track record in development and a strong foundation for global responsibilities in a late stage project including communication, alignment and success in association with regulatory strategies for large, complex submissions with a demonstrated ability to effectively influence development team decision making.

Preferred

  • Experience leading in a multi-national environment
  • Proven track record in leading submissions and achieving approvals for an NME across the EU, Japan and the US based upon a global development plan.

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Regulatory Affairs

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