Manager Regulatory Affairs, Benelux
il y a 2 semaines
Manager Regulatory Affairs, Benelux & Ireland
Location
Function/Business Area
Regulatory Affairs
Department
Regulatory Affairs
Employment Class
Permanent
DescriptionManager Regulatory Affairs, Benelux and Ireland
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 Benelux and Ireland, you are responsible for arranging the provision of regulatory expertise and execution of regulatory strategy & activities including contact with and submissions to the local Health Authorities, management of product information and artwork. Ensure regulatory compliance with Astellas policies, regional/ local regulations and the registered dossier including review/approval of promotional materials.
You will be part of an inclusive team that works to develop innovative therapies for patients.
Hybrid Working:
At Astellas, we recognize that our employees enjoy having a 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 Responsibilities:
- Ensure timely preparation, submission and follow up of regulatory applications to ensure maintenance of marketing authorizations including preparation of regional specific documents. Execute tasks related to EU licenses e.g. translations.
- Contribute to the regulatory strategy wherever possible and needed and communicate the affiliate input to Regulatory Affairs (RA). Including advising on optimal labelling, Expended access programs/Companion Diagnostics (EAP/CDx).
- Maintain training compliance & help co-workers understand the impact of appropriate training.
- Provide strategic support & maintain close relationships within local affiliate; participate in launch & brand teams & align RA activities to other departments.
- Ensure regulatory compliance & 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 EST-RA and within the affiliate. Communicate & apply the regulatory strategy in the local affiliate.
- Extensive in contributing to the development and execution of brand strategy, delivering outstanding results versus budget, with strong expertise in forecasting and setting ambitious KPIs.
- Clear understanding in co creation with headquarters and local Benelux and Ireland (BNLI) brand team.
- Experience of working in a Pharma commercial organization or similar environment.
- Established track record in the planning, measurement, and revenue growth of omnichannel stakeholder journey projects.
- Excellent understanding of omnichannel engagement leveraging digital opportunities while fostering customer engagement.
- Experience of implementing co-created patient centric integrated services, solutions, and programs.
- Fluent in written and spoken business English, Dutch and French.
- Extensive and clear understanding of regulatory strategy and compliance. Demonstrated experience in preparing and submitting regulatory applications to maintain marketing authorizations, with a focus on regional-specific documentation and EU licensing requirements.
- Proven experience in regulatory information management. Skilled in managing product information and artwork, providing strategic advice on label strategy, and ensuring the availability of approved product documentation for internal and external use.
- Strong communication and relationship-building skills. Ability to autonomously engage with health authorities and maintain professional relationships with external stakeholders, ensuring regulatory compliance and fostering a positive reputation for the organization.
- Strategic support and collaboration within local affiliates. Experience in participating in launch and brand teams, aligning regulatory activities with cross-functional departments, and leading local meetings to enhance operational efficiency.
- Strong knowledge of promotional materials review and approval processes. In-depth understanding of relevant codes, ensuring efficient and risk-based processes for the review and submission of promotional materials to health authorities.
- Managerial and leadership capabilities. Strong planning, problem-solving, and influential communication skills.
- Master's in pharmacy/medicines or equivalent (you must be the holder of a legal pharmacist, doctor, or veterinarian diploma).
- This is a permanent, full-time position.
- This position is based in Belgium.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per week in the Belgium office. Flexibility may be required in line with business need. Candidate 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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