June 24, 2022

Senior Manager Regulatory Labelling

 Astellas Pharma B.V.

Senior Manager Regulatory Labelling

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

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.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

Amongst the main responsibilities for this role are the following:

  • Responsible for development, implementation, and change control of new and revised labeling for assigned Astellas products and areas within the Rest-of-World (ROW) region.
  • Ensures compliance with Company Core Data Sheets, applicable regional health authority requirements, and internal procedures and alignment with business needs.
  • Researches government initiatives related to labeling and packaging, and assures that Astellas adopts new initiatives according to prescribed timelines.
  • Requires significant interaction outside the Regulatory Affairs department on complex issues and questions.
  • Maintains a positive working relationship with global internal stakeholders and business partner

Essential Knowledge & Experience:

  • Drives labeling development for regional product launches and ensures that all labeling meets company and regulating health authority specifications.
  • Manages English Master files and translation of text into local languages according to individual country requirements (where appropriate).
  • Serves as leader of cross-functional labeling review team meetings; organizes, compiles, and maintains all documentation and assures compliance of manual and electronic label history files.
  • Assures compliance of local labeling by evaluating all CCDS/CCSI changes and implementing according to prescribed timelines.
  • Advises cross-functional teams on labeling content consistency and best practices regarding planning and execution.
  • Collaborates with Regulatory Affairs cross-functional teams on submission and implementation strategy for labeling.
  • Actively supports the systems, processes, and operations for development of and changes to labeling, and assures compliance to those procedures.
  • Establishes strong working relationships with global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply.
  • 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.

Additional information:

  • Currently this position has the flexibility to work from home and in the office.
  • Full time.
  • The role can be based in different locations: UK, Netherlands, US or Japan.

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.

Jessica Poznelli

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