Director Labeling Strategy - Nederland - Astellas Europe

Beschrijving

Director Labeling Strategy

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.

This opportunity is located in the Netherlands for the Director Labeling Strategy, Global Labeling Lead.

About this job

As the Director Labeling Strategy, Global Labeling Lead at Astellas Pharma Global Development, you will be at the forefront of driving innovation and excellence in regulatory strategies for CCDS and product labeling within the dynamic field of Oncology. Your pivotal role will empower you to shape the future of pharmaceutical labeling, guiding the development of life-saving treatments and ensuring their seamless integration into global markets. By leading labeling development initiatives and fostering collaboration across regulatory teams, you will inspire transformative change and uphold the highest standards of regulatory compliance. Join us in making a meaningful impact on healthcare worldwide.

Hybrid working

At Astellas we recognize the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimizing the most productive work environment for you to succeed and deliver.

In this job, you will:

• Lead CCDS Labeling activities for Oncology products, overseeing labeling development, updates, and maintenance.
• Serve as the EMA Labeling Lead, ensuring consistency across product labels and implementing process improvements.
• Liaise with key regulators including FDA, Health Canada, PMDA, and EMA for formal negotiations.
• Identify risk areas and develop contingency plans, anticipating regulator responses.
• Collaborate cross-functionally with commercial, legal, safety, medical, and other teams to achieve labeling objectives.

Essential Knowledge & Experience:

• Experience in Regulatory Affairs in the area of labeling development and review for prescription pharmaceuticals or similarly regulated industry.
• Demonstrated a proficient understanding of regulations, guidelines, and industry precedents pertinent to pharmaceutical product development and marketing, specialized focus on product labeling and packaging, ensuring adherence to stringent regulatory standards and best practices.
• Ability to exercise sound judgment and operate with a high degree of independence regarding routine and non-routine assignments.
• Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved and in-use labeling.

Preferred Knowledge & Experience:

• Excellent planning, organizational, analytical, problem-solving, and decision-making skills.
• Possesses excellent written and verbal communication skills.
• Proficiency in a second language is a plus.

Education:

• Bachelor's degree preferably in a life sciences field or equivalent.

Additional information:

• Permanent position.
• This position follows our hybrid working model. Role requires a blend of home and 1 Day in our office. Flexibility may be required in line with business need. 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.