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Vacatureadvertentie

Associate Manager, RA, Clinical Trial Unit

Locatie

Nederland

Functie/Business Area

Regulatory Affairs

Afdeling

RA - Clinical Trials & Processes

Werkcategorie

Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

Associate Manager, Regulatory Affairs, Clinical Trial Unit

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 Associate Manager, RA, Clinical Trial Unit, you will be responsible for successfully developing regulatory strategies, plans, and processes for assigned clinical trials and projects. The assigned area of responsibility may be focused on global and regional clinical trials for compounds in development or compounds already marketed for certain indications.
You will also be responsible as a regional study team member for obtaining and maintaining clinical trial authorizations.

Hybrid Working:
At Astellas we recognize 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.

Key Activities for this role:
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 of scientific and regulatory experience applicable to the role. A 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 guidelines.
Strong interpersonal, verbal, and written communication skills.
Excellent analytical and problem-solving skills.
Fluent in written and spoken business English.

Preferred Knowledge & 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.