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.
The Opportunity:
As the Regulatory Affairs Manager, you will be responsible for the successful development of regulatory strategies, plans and processes for assigned clinical trials and/or projects. The assigned area of responsibility may be focused on global and/or regional clinical trials for compounds in development or compounds already marketed for certain indications. You are responsible as a regional study team member for obtaining and maintaining clinical trial authorizations
Hybrid Working:
At Astellas we recognise 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; optimising the most productive work environment for you to succeed and deliver.
Key Responsibilities:
- Provide clinical trial input and ensures alignment with regulatory strategies for global programs and products in study teams and GRETs (Global Regulatory Extended Team)
- Submit and maintains clinical trial applications globally and ensures all applicable regulatory requirements are met.
- Collaborate with Global Regulatory Lead (GRL) and Regional Regulatory Leads (RRLs) to assure clinical trial regulatory strategies reflect scientific, therapeutic, and regulatory expertise and knowledge and ensures Astellas’ clinical trial programs meet all applicable regulatory and business requirements.
- Interact with global and regional peers, project and/or product team members and regulatory management to align Astellas’ regulatory clinical trial strategies.
- Responsible for the preparation of and submission to regulatory authorities of technical documents for assigned clinical trials. Reviews data summaries from research, development, and manufacturing reports for adequacy in content, quality, interpretation, and regulatory/scientific rigor.
- Responsible for execution of the agreed regulatory strategy into regulatory clinical trial applications across assigned development projects and/or commercial products
Essential Knowledge & Experience:
- Proven experience in a discipline associated with pharmaceutical development or product oversight.
- In-depth knowledge in Scientific and regulatory experience applicable to the role. Solid basis in scientific approach, ability to deal with technical information from a variety of disciplines.
- Strong knowledge in technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and including knowledge of regulatory requirements and ICH guidance’s.
- Strong interpersonal, verbal, and written communication skills.
- Excellent analytical and problem-solving skills.
- Fluent in written and spoken business English.
Preferred Knowledge and Experience:
- Experience in Regulatory Affairs.
Education/Qualifications:
- Bachelor’s degree or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is based in the Netherlands.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in the Netherlands office. Flexibility may be required in line with business needs. 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.
