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Astellas Pharma · 2 days ago

Regulatory Affairs Lead, Oncology (Sr. Manager)

Northbrook, IL

Full-time

Hybrid

Mid, Senior Level

$122K/yr - $192K/yr

5+ years exp

Astellas Pharma Inc. is a pharmaceutical company committed to developing innovative therapies for patients. The Regulatory Affairs Lead will be responsible for developing and executing regulatory strategies for complex projects, ensuring compliance with regulatory requirements, and leading interactions with regulatory authorities.

BiotechnologyHealth CareMedical

Comp. & Benefits

Responsibilities

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

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

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

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

Qualification

Regulatory AffairsPharmaceutical DevelopmentRegulatory StrategyGMP ComplianceICH GuidanceAnalytical SkillsInterpersonal SkillsNegotiation SkillsWritten CommunicationVerbal Communication

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