Vacatureadvertentie
Manager, Regulatory Affairs Netherlands & Ireland
Locatie
Nederland
Functie/Business Area
Missing req details TBC
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd
Functiebeschrijving
Manager, Regulatory Affairs Netherlands & Ireland
About Astellas:
At Astellas, experience is coupled energised with a relentless challenger spirit.
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 are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.
We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.
We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.
The Opportunity:
As Regulatory Affairs (RA) Manager Benelux & Ireland, you will be responsible for arranging the provision of regulatory expertise and execution of regulatory strategy and activities, including contact with and submissions to the local Health Authority (HA) and management of Product Information and artwork.
In this position, the submissions under your scope may include, but are not limited to, initial Marketing Authorization Applications and its associated submissions, variations, Product Safety Updates Reports (PSURs), promotional materials and notifications.
You will work to ensure regulatory compliance with Astellas policies, regional/local regulations and the registered dossier including review/approval of promotional materials.
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:
Regulatory strategy and compliance: Ensure timely preparation, submission and follow up of regulatory applications to ensure maintenance of marketing authorizations, including preparation of regional-specific documents. Executes tasks related to EU licenses (e.g ,translations).
Contribute to the Regional regulatory strategy wherever possible and needed and communicate the local affiliate input to regional RA, including advising on optimal labeling, EAP/CDx.
Communicate RA milestones and outcomes to the relevant stakeholders, including internal and external systems. Perform data entry in relevant databases and trackers.
Product Information (i.e., SmPC / aPI / PIL / aRMM) and artwork management. Provide advice to regional RA on label strategy. Make the approved Summary of Product Characteristics (SmPC) or/and the leaflets, available for internal and external use. Advises on implementation tactics for PI updates.
Promotional materials: Review/approve promotional materials with an in-depth understanding of code. Provide input to above-country materials review. Understand and interpret scientific data and make recommendations and informed decisions.
Internal stakeholders: Provide strategic support and maintain close collaboration within global and regional Regulatory Affairs and Pharmacovigilance (RAPV) groups and local affiliate. Participate in launch and brand teams and align RA activities with other departments. Participate in local affiliate and other project team meetings as needed.
External stakeholders: Autonomously communicate with HA. Ensure regulatory compliance and reputation. Develop and maintain professional relationships with relevant external contacts including the Health Authority and Trade Associations. Monitor, apply and communicate local regulatory intelligence within regional RA and the affiliate.
Essential Knowledge & Experience:
Extensive experience in Regulatory Affairs area.
Fluency in English language (read, write, speak).
Education/Qualifications:
Bachelor’s degree in life sciences 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 minimum 2 days per week in our respective local affiliate office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
We offer:
A challenging and diversified job in an international setting.
Opportunity and support to continuous development.
Inspiring work climate.
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.
#LI-Leiden #LI-Hybrid #LI-CC1
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