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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 and Scope:

+ Responsible for the development and successful execution of regulatory strategies, plans and processes for assigned projects and/or products with considerable technical complexity and diversity requiring impact on 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 within a region.

+ Responsible to be a Regional Regulatory lead or Global Regulatory Lead, for development programs (early stage of clinical development), or as a regulatory representative for commercial products requiring multifaceted 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; influences internally and externally to contribute to project/product decision making ensuring viable regulatory approaches and interacts with regulatory agencies.

+ Accountable for project-related and marketed product-related communications and interactions with project and/or product team members, regulatory authorities and health agencies requiring impact on decision making; incorporates regulatory environment trends to ensure the projects/products reflect 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. Advises project/product teams in the application of regulatory strategies and solving of regulatory issues.

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

Responsibilities and Accountabilities:

Regulatory Excellence

+ Leads the development, implementation and successful application of robust regulatory strategy input to assigned areas for submissions such as MAA, NDA and variations associated with early-stage development programs, development of new indications / formulations and/or commercial products and is accountable for the expert review of major deliverables from a regulatory perspective.

+ Leads regulatory development in GRL or regional regulatory lead roles in the context of Development TAs and Core Teams and Regulatory Extended Teams for programs with considerable complexity requiring impact on internal and external decision making.

+ Applies understanding of regulatory requirements and trends into the development of aligned regulatory strategies.

+ Develops and 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.

+ Accountable for the preparation and submission of 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 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 provide oversight on regulatory matters; and where needed, directs the contributions to meetings with regulatory authorities and similar experts and bodies.

+ Guides Extended GRA team members, Regional Regulatory Leads or other GRA staff in a matrix organization on regulatory and decision-making issues. Shares relevant information and drives development of viable strategies and/or methodologies which reflect 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.

+ 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.

+ 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.

+ 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. 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).

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

Qualifications:

Required

+ Bachelor’s degree in science required; Master’s degree in science preferred

+ 5+ (e.g. 5-7) 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 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 guidance.

+ Proven track record of interaction with regulatory authorities.

+ Very good interpersonal, verbal and written communication skills with an ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders.

+ Strong analytical and problem-solving skills

+ Good negotiation skills

Preferred:

+ Experience participating in a multi-national environment

+ Proven track record in submissions and achieving approvals.

+ For roles within a GRA development TA, a track record in development and a foundation for global responsibilities in a development project including communication, alignment and success in association with regulatory strategies is preferred.

Salary Range

$130K – $170K (NOTE: Final salary could be more or less, based on experience)

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 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

\#LI-SS

Category Regulatory Strategy- Oncology

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans