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Astellas Pharma Associate Director/Director, Regulatory Affairs (Regenerative Medicine) in Northbrook, Illinois

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 www.astellas.com .

This position is based in Northbrook, Illinois. 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 & Scope:

Reports to RA Team Lead within a TA. Responsible for regulatory leadership and oversight for the assigned area(s), including development and successful execution of regulatory strategies, plans and processes with high impact and complex internal decision making. 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 global RA TA or within a region.

Responsibilities may be as a Global Regulatory Lead for advanced, complex development programs, or as a regulatory representative for commercial products, of high impact requiring complex internal decision making. Assures 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. Ensures regional alignment with regulatory strategies for global programs and products.

Responsible for interacting with Global TA Head to align Astellas' regulatory strategies to support Astellas' strategic goals; influences policy making bodies both internally and externally, and interacts with regulatory agencies. May interact with industry/trade associations to influence policy change.

Accountable for project-related and marketed product-related communications and interactions with regulatory authorities, health agencies, key opinion leaders and business partners which require high impact and complex internal decision making; interprets and incorporates regulatory environment trends and policies ensuring the programs/projects reflect the most up-to-date regulatory strategies.

Collaborates within a matrixed regulatory team to accomplish objectives Ensures the development of knowledge and expertise of regulatory staff, advising project/product teams in the application of regulatory strategies and solving of complex regulatory issues.

Collaborates with Astellas RA Team Lead 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 development programs and/or commercial products leveraging deep understanding of scientific and therapeutic area knowledge to teams, which may include Development Core Teams and Extended Regulatory Teams, and is accountable for the expert review of major deliverables from a regulatory perspective. Leads regulatory development in/for GRL roles in the context of Development TAs and Core Teams and Regulatory Extended Teams for programs requiring high impact. Applies expert 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 across assigned areas. 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.

Provides added oversight to CMC operations, processes, and strategy. Collaborates with RA CMC

to ensure products, projects and regions are aligned in strategy and tactics.

Provides oversight on regulatory matters; and where needed, directs the contributions to meetings with regulatory authorities, key opinion leaders and similar experts and bodies through his/her staff.

Guides other GRLs, Extended RA team members or other RA staff in a matrix organization on

challenging, complex regulatory and decision making issues. Provides expert opinions, advises staff on available strategies and/or methodologies which reflect the most up-to-date regulatory and compliance standards.

Provides oversight of staff, approves regulatory components and reviews/participates in the evaluation of in-licensing opportunities and due diligence activities.

Stays at the forefront of regulatory policy developments, guidelines, and industry trends in drug development, particularly with respect to the therapeutic area(s) assigned, and prepares recommendations and expert opinions for Executive Management in a timely manner.

Interprets, identifies, recommends, and advises project/proRAm 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 expert regulatory advice to ad hoc teams/task forces set up for process improvements, alignment with new regulatory requirements or business initiatives on behalf of RA.

Contributes to the strategy for interaction with Health Authorities or business partners in the assigned area. Builds and maintains good relationships with Regulatory Authorities.

Organization & People Management:

Develops an environment to enable each member of the Regulatory Affairs team to optimally operate in the matrix environment of RA, Medical Development, Technology/PPM and Astellas (e.g.MS, regional commercial businesses, Medical Affairs, Legal, affiliates, etc.).

Responsible for mentoring and training and may supervise RA staff. 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 RA strategy and mid- and long-term Astellas strategy and conformity with Corporate guidelines.

Represents RA within the assigned area 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 major 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 $200 million.

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 RA Team Lead.

Has accountability to the Global RA TA Head for global development programs. Collaborates with a matrix team of regulatory professionals and supports staff which may include GRL, Extended Team members, Core Medical Team members, or other RA staff who are assigned to programs and/or products. Peers to this position include RA TA Liaison, management across functions within MD and within a region, senior MA and PV staff, and senior Technology/PPM staff..

Qualifications:

Required:

  • Bachelor of Science degree; advanced scientific-related degree strongly preferred.

  • 10+ years pharmaceutical drug development (pharmaceutical industry or institutions) with minimum of 5 years in regulatory affairs.

  • 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.

  • In depth technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and an in depth knowledge of regulatory requirements including ICH guidances.

  • Demonstrated successful experience in applying current and evolving regulatory requirements to projects/programs.

  • Ability to navigate a globalizing organization and to act globally and regionally as appropriate.

  • 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.

  • Roles within a RA TAH require a proven track record in global development including alignment and success in association with global regulatory strategies and a demonstrated ability to effectively lead a matrixed team.

  • Excellent verbal and written communication skills

  • Strong analytical and problem solving skills

  • Proven leadership and negotiation skills

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.

  • A track record of success as a manager of staff, including providing direction, building and motivating teams, driving alignment to business goals and individual development.

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Category Regulatory Affairs

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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