General Information

Job Advert Title
Sr Mgr, Regulatory Labeling
Location
Netherlands
Function/Business Area
Regulatory Affairs
Department
CCDS and Labelling
Employment Class
Permanent

Description

Senior Manager Regulatory Labelling

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 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 partners.

Key Activities are noted below:

  • 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.

Experience and Knowledge:

  • Extensive previous industry experience;
  • Significant experience in Regulatory Affairs, including working within a global environment.
  • Direct pharmaceutical labeling development experience required with demonstrated proficiency in managing change control.
  • Experience with managing projects and working within a matrixed organization.
  • Knowledge of Regulatory landscape, systems and procedures for CCDS and Labeling.
  • Proficiency in English language.
  • Excellent communication, influential, planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders.
  • Proven affinity and capability to work within teams where there is no direct reporting relationship.

Qualifications:

  • Bachelor’s or MS Degree in Pharmacy or other Life Science or equivalent by experience

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.