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Lead, Regulatory Affairs Intelligence


General Information

Job Advert Title
Lead, Regulatory Affairs Intelligence
Function/Business Area
Regulatory Affairs
Regulatory Intelligence
Employment Class


Lead, Regulatory Affairs Intelligence

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.

The Opportunity:

As a Lead of Regulatory Affairs Intelligence, you will be accountable for gathering and disseminating regulatory intelligence, delivering situational analyses, and making recommendations that encompass both the present regulatory landscape and the anticipated/desired future healthcare environment to bolster global and regional regulatory policy advocacy endeavors. You will be responsible for policy advocacy topics on global scale. Your position will be pivotal in engaging with internal departments across the organization and external stakeholders such as Trade Associations, Key Opinion Leaders (KoLs), and regulatory bodies.

Hybrid working:

At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

In this role, you will:

  • Monitor and track upcoming regulatory legislations, providing analysis and targeted dissemination of regulatory intelligence to Regulatory Affairs and cross-functional stakeholders via various channels.
  • Manage internal processes concerning draft/final guidelines, contributing to guideline consultancy processes in line with company strategy.
  • Contribute to cross-functional initiatives, representing the Regulatory Intelligence and Policy function and/or Regulatory Affairs department and contribute to the development of Company positions and Action Plans for policy advocacy globally.
  • Participate in industry working groups such as PhRMA, JPMA, EFPIA, RDPAC and BIO and participate and in Public-Private Partnerships or consortia such as IHI to represent Astellas
  • Provide internal consultancy on regulatory information, interpretation of regulatory documents, and regulatory advice upon request.

Essential Knowledge & Experience:

  • Significant experience within Regulatory Affairs, pharmaceutical industry, or related experience..
  • Scientific knowledge and regulatory experience applicable to the role and solid basis in scientific approach, an ability to deal with technical information from a variety of disciplines.
  • Experience in information searching and associated technology.
  • Skilled networker and strong communication and collaboration skills
  • High integrity to maintain confidential and proprietary information.

Required qualification:

  • Health Science Diploma or equivalent.

Additional information:

  • This is a permanent full-time position.
  • Position is based in the Netherlands.
  • This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per month in our Leiden office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

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.

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