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Job Advert Title
Associate Director Regulatory Affairs Labeling Strategy
Function/Business Area
Regulatory Affairs
Regulatory Affairs
Arbeidsovereenkomst voor onbepaalde tijd


Associate Director Regulatory Affairs Labeling Strategy

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 collaborating with strategic regulatory for development of regulatory strategy and support in the area of CCDS and product labeling for products in development programs as well as life cycle management of existing portfolio for key country labeling. Provide oversight to other Regulatory personnel including regional leads and ROW labeling implementation leads who are responsible for developing labeling/packaging or managing labeling content and ensure consistency across product labels.

Advise global internal stakeholders and business partners on best practices regarding planning and execution of labeling strategies. Collaborates to assure labeling-relevant aspects of global and local regulatory strategies reflect best in class applications and meets all applicable regulatory and business requirements.

Amongst the main responsibilities for this role are the following:

  • Functions as the CCDS Labeling Lead responsible for leading the creation, implementation and maintenance of the Company Core Data Sheets applying scientific and clinical knowledge to the process.
  • Manages labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.
  • Provide oversight to other Regulatory personnel including regional leads and ROW labeling implementation leads who are responsible for developing labeling/packaging or managing labeling content and ensure consistency across product labels. .
  • Uses the appropriate company systems, processes, and operations for development of and changes to labeling. Assures that cross-functional labeling processes are compliant with approved company procedures and manages process improvement initiatives.
  • Advises cross-functional teams on labeling content consistency and best practices regarding planning and execution. Participate in identification of risk areas and develops alternative courses of action including anticipation of HA responses through scenario planning and development of contingency plans.
  • Effectively applies strong working knowledge of FDA, EU, Japan, and China guidance, labeling standards and medical and scientific content.
  • Actively supports the systems, processes, and operations for development of and changes to CCDS and key labeling, and assures compliance to those procedures.
  • Establishes strong working relationships with local and global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply. Works closely with individuals/groups to influence others to facilitate consistency, efficiency, quality and compliance.
  • Makes and executes challenging decisions based upon sound regulatory knowledge, but also recognizes when a decision should be elevated to upper management for further consideration. Keep management apprised of critical issues which may impact the success of the organization.

Essential Knowledge & Experience:

  • Bachelor's degree.
  • Previous industry experience; solid experience in Regulatory Affairs in the area of labeling development.
  • Demonstrated expert proficiency in managing and control of pharmaceutical labeling in accordance with local and global regulatory requirements. Direct pharmaceutical labeling development experience required.
  • Proven proficiency with relevant key country local health authority regulations and guidelines for labeling development, implementation, and compliance requirements, and applies understanding to business situations.
  • Proven effectiveness with stakeholders in the labeling system from content development through commercial supply.
  • Previous experience working with US and ex-US labeling requirements, company core data sheet (CCDS) implementation and execution, and other regulatory requirements impacting or associated with labeling.
  • Must be able to effectively influence peers both inside and outside the organization and maintain effective working relationships.
  • Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously Excellent written and verbal communication skills (native and non-native English speakers).
  • High integrity with respect to maintenance of proprietary, confidential information.

Additional information:

  • Currently this position has the flexibility to work from home and in the office.
  • This position is based in Leiden.
  • 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.