General Information

Job Advert Title
Regulatory Operations Associate Director
Location
Netherlands
Function/Business Area
Regulatory Affairs
Department
Regulatory Affairs
Employment Class
Permanent

Description

Regulatory Operations Associate Director


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 global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

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 Data Integration and Optimization. The Data Integration and Optimization Associate Director is expected to be an expert in this area and should have substantial knowledge of the other two Regulatory Operations areas and how they relate to one another, how our Regulatory systems interact, and how they interface with other aspects of the Astellas' information ecosystem.
  • Responsibilities involve organizing underlying informatics aspects of projects/products, including the data elements used in submission planning among different systems, registration management and both document- and data-centric submissions to regulatory agencies and establishing relationships with key personnel within the global Regulatory Affairs organization to identify process improvements.

This position also involves the following aspects:

  • Incorporates industry specifications/initiatives into our processes and deliverables
  • Contributes to and sometimes leads cross-functional and/or industry initiatives including IT system implementations and process re-engineering projects, capable of representing all of Regulatory Operations.
  • Proactively resolves complex and diverse business problems with decision-making that impacts area of responsibility and Regulatory Operations as a whole
  • Manages one's own tasks and deliverables in alignment with his or her line manager

Key Activities are noted below:

  • Contributes to Regulatory Operations strategy by implementing actionable plans for near- and long-term process improvements involving RA systems as well as interactions with other functions such as Supply Chain, Pharmaceutical Technology or Pharmacovigilance.
  • Leads or participates in cross-functional initiatives involving regulatory information, with particular emphasis on integrations with systems outside of RA, shared information taxonomies and data dictionaries
  • Leads or participates in industry working groups to represent Astellas, often in collaboration with other RA members including Regulatory Intelligence colleagues, spanning information needs for all RA functional departments
  • Liaises with Information Systems and other Planning and Administrative functions on a variety of topics including platform strategies and IT roadmap prioritization
  • Tracks alignment of operating models across all concerned RA functional departments (Therapeutic Areas, Affiliates, CMC, Regulatory Intelligence, CCDS & Labeling, Regulatory Operations, Planning and Administration, Compliance and AdPromo groups) during vendor/system selection activities, while preparing for new/major system implementations, and when evaluating ongoing process improvement opportunities in steady state.
  • Stakeholders

Internal:

  • Interacts cross-functionally with all concerned RA functional groups (Therapeutic Areas, Affiliates, CMC RA, Regulatory Intelligence, CCDS & Labeling, Regulatory Operations, Planning and Administration, Compliance and AdPromo groups) at all levels in the RA organization.

External:

  • The position requires collaboration to ensure consistency in interactions with multiple regional health authorities and other Astellas functions such as Pharmacovigilance, Marketing Operations, Data Science, Supply Chain, Manufacturing and other areas within Medical & Development. The Associate Director also leads or otherwise participates in significant and complex project teams/task forces.
  • Liaises with Information Systems and other Planning and Administrative functions on a variety of topics.
  • May interact with one or more industry working groups/subgroups such as IRISS or EFPIA.

Experience and Knowledge:

  • 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.
  • 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.

Qualifications:

  • BA or BSc in Science.

Additional information:

  • Currently this position has the flexibility to work from home and in the office.
  • This is a permanent full-time position based in the UK or in the Netherlands.

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.