Algemene informatie

Job Advert Title
Associate Director Regulatory Affairs
Locatie
Nederland
Function/Business Area
Legal, Risk, Ethics & Compliance
Afdeling
RA - Regional TA Oncology
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

Associate Director Regulatory Affairs Oncology


About Astellas:


At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.

Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.

Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.


About this job:


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 of 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 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.


Amongst the main responsibilities for this role are the following:


  • 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.
  • 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 ( 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.

Essential Knowledge & Experience:


  • Extensive experience in a discipline associated with pharmaceutical development or product oversight; significant experience 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.
  • Proficient technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and including knowledge of regulatory requirements and ICH guidance.
  • 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.
  • 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.

Additional information:


  • Currently this position has the flexibility to work from home and in the office.
  • This position is based in the Netherlands (Leiden) or in the UK (Addlestone).
  • Full time.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.