Associate Regulatory Affairs Director, Chemistry Manufacturing and Controls
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.
About this role
As an Associate CMC Regulatory Affairs Director, you'll lead global Regulatory Affairs for Chemistry, Manufacturing, and Controls (CMC) in regulatory documents and submissions. Your role involves overseeing multiple regulatory tasks, collaborating with various stakeholders (such as other RA functions, Pharmaceutical Technology, Quality Assurance, and Business Partners). You'll develop global CMC regulatory strategy, drive related activities globally, and execute regulatory plans in collaboration with stakeholders. Additionally, you'll handle crucial interactions within and outside Astellas Regulatory Affairs concerning complex CMC issues in partnership with local and global stakeholders.
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
In this role you will:
Essential Knowledge & Experience:
Preferred Experience:
Required qualification:
Additional information:
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.
Functie: | Associate Regulatory Affairs Director, Chemistry Manufacturing and Controls |
Startdatum: | 21-12-2023 |
Ervaring: | Ervaren |
Educatielevel: | HBO |
Contracttype: | Vast |
Salaris: | onbekend – onbekend |
Uren per week: | 32 – 40 |
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Deel de vacature:
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