Senior Pharmaceutical Regulatory Manager
4 dagen geleden
About Astellas: At Astellas, we are a progressive health partner dedicated to delivering value and outcomes where needed. We pursue innovative science, focusing on 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 healthcare professionals on the front line to ensure patient and clinical needs guide 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.
We believe all staff have a role to play in creating a patient-centric culture and integrating awareness of the patient into our everyday working practices, regardless of our role, team, or division. As the Senior Pharmaceutical Regulatory Manager, you will play a key role in a global leadership position.
Your responsibilities will include driving global CMC RA-related activities, successfully executing regulatory strategies in collaboration with stakeholders, and supporting business-critical interactions inside and outside Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders.
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.
You will manage a small team or mentor one or more individuals, act as a CMC regulatory expert for global project teams, recommend CMC regulatory strategies, and ensure alignment with global and local stakeholders.
You will oversee the preparation and review of complex global registration packages, ensuring effective data presentation and compliance with regulatory requirements. You will collaborate with stakeholders to enhance submission quality and prepare summary tables from research and manufacturing reports.
You will also ensure timely compilation and submission of global documents, reviewing for consistency and quality across regions, including eCTD Module 3 documents. Your ability to stay informed on corporate/global strategy and regulatory positions will enable you to contribute to strategic planning in the therapeutic area and CMC aspects with global stakeholders.
The ideal candidate will be detail-oriented, goal-driven, quality-conscious, and customer-focused, with excellent analytical thinking skills and the ability to manage complex projects independently.
A fluent written and spoken business English speaker, you will hold a Doctorate in Chemistry/Biochemistry/Engineering, PharmD, or equivalent degree, and possess relevant experience in CMC regulatory or a role with CMC regulatory submission responsibilities.
Experience managing direct reports is preferred, and additional experience beyond small molecules, such as biologics, vaccines, cell/gene therapy, or medical devices, might be a preference.
This is a permanent, full-time position based in the United Kingdom or the Netherlands. The role requires a blend of home and a minimum of 1 day per week in the Netherlands office.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
£80,000 - £110,000 per annum (dependent on experience) + benefits package
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