Dir Labeling Strategy

Director, 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.

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

About this job:

As the Director of 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.