Vacatureadvertentie
Manager RA Nordics
Locatie
Denemarken
Functie/Business Area
Missing req details TBC
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd
Functiebeschrijving
Manager RA Nordics
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing 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.
Opportunity:
You’ll arrange the provision of regulatory expertise and oversee the execution of regulatory strategies and activities, including communication with the local Health Authority (HA), submission of applications, and management of Product Information and artwork.
You’ll manage submissions, which may include (but are not limited to) initial Marketing Authorisation Applications and associated filings, variations, PSURs, promotional materials, and notifications.
You’ll ensure regulatory compliance with Astellas policies, regional and local regulations, and the registered dossier, including the review and approval of promotional materials.
Hybrid Working:
At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Responsibilities and Accountabilities:Regulatory strategy and compliance:EU and non-EU :
Preparing local submission documents.
Managing submissions to the national authority under supervision and following up accordingly.
Performing local tasks related to EU centralized licenses (e.g., translations).
Communicating RA milestones and outcomes to relevant stakeholders, including internal and external systems, while performing data entry in relevant databases and trackers.
Managing regulatory information, including updating internal and external systems.
Managing Product Information (i.e., SmPC / aPI / PIL / aRMM) and artwork.
Making the approved Summary of Product Characteristics (SmPC) and/or leaflets available for internal and external use.
Maintaining training compliance and supporting co-workers in understanding the impact of appropriate training.
Promotional materials:
Reviewing promotional materials in line with the local code.
Working on project teams to implement improvements and update procedures.
Understanding and interpreting scientific data and making recommendations.
Submitting promotional materials to the HA, as applicable.
Internal stakeholders:
Liaising with Quality Assurance (QA) and/or Supply Chain Management (SCM).
Participating in local affiliate meetings and project teams as needed.
Performing and supporting GxP tasks, as applicable (e.g., PQR review, follow-up, or drafting procedures).
Providing support to PV and/or QA, as required.
External stakeholders:
Communicating with the local HA under supervision.
Developing (or maintaining) external relationships and networks across other companies.
Monitoring, applying, and communicating local regulatory intelligence to headquarters and within the affiliate.
Required Experience:
Industry experience in Regulatory Affairs.
Preferred Experience:
Pharma sector experience
Education:
Degree in Pharmacy, Chemist, Biology or equivalent
Working Environment:
The is a permanent full-time position based in the Denmark.
This position follows our hybrid working model. Role requires a blend of home and minimum of 1 day a week in office. Flexibility may be required in line with business need. 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.
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