Senior Regulatory Affairs Manager
Astellas

Job Info

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 a Senior Regulatory Affairs Manager opportunity in Northbrook, IL.



Purpose & Scope:


* Reports to a RA Team Lead within a TA. 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 RA TA Heads or Team leads 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 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 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 RA 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 RA team members, Regional Regulatory Leads or other RA 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 RA.
* 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 RA, Medical and Development, Technology/PPM and Astellas (e,g, MS, regional commercial businesses, Medical Affairs, Legal, affiliates, etc).
* Represents RA 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 Astellas business and indirect impact on the development strategy for projects with the assigned area with budgets <$50 million.
* Direct impact on the successful registration of new products, indications, line extensions and/or on the revenue generation from a given mature product (range) < $100 million per year per region.

Organizational Context:


* Position reports to a RA Team Lead within a TA
* May lead an Extended Regulatory Team including Regional Regulatory Leads and other RA staff for global projects and other RA staff for regional projects and products. Peers to this position include peer RA staff, peers across functions within MD 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'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 guidances.
* 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 RA 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.



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