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Head of Regulatory Affairs & Quality Benelux
Hudson BeneluxMerelbeke, Oost-VlaanderenIl y a plus de 30 jours
Description de posteSupporting of designing innovative regulatory strategies that seek to accelerate the availability of medicines in countries. Responsible for advising global teams on the country's regulatory framework for post-marketing modifications, new marketing authorizations, clinical studies, EAP, etc. Act as main contact & expert externally : with HA, & Pharma-associations and internally among all other groups within Ipsen Ensure that the labeling complies with all relevant regulations and guidelines Define best strategy for submission and build a comprehensive plan Stay fully updated on applicable regulatory requirements such as ICH, GDP, GMP, Ipsen standards. Participation to regulatory intelligence process and, where necessary, escalation with technical expertise, assessment and solution proposals. You have a degree as Medical Doctor / Pharmacist / PhD and are qualified as GDP Responsible Person You have 8-10 years experience in a Regulatory / Quality role within a Specialty Care environment is a plus. You have experience in QA and RA. You have the ability to influence and have managerial skills. You have experience working in a Cluster or matrix organization. You are proficient in English & Dutch, French is preferred. You have the capacity to undertake regular travel through the Benelux Cluster. You have a strategic way of thinking (e.g. understand needs, identify issues and opportunities, develop targeted multifaceted solutions, find ways to operate differently by focusing on high added value tasks). You have a comprehensive understanding of the Benelux regulatory environment. You have the ability to review and analyze business and medical data and apply project management skills and experience. You have thorough knowledge of European and local legislation related to given area of responsibility and industry ethical codes including but not limited to ICH, GDP, GMP guidelines. The opportunity to work in a highly agile company passionate about science and innovation, where diversity and an entrepreneurial spirit are celebrated A competitive salary package with a lot of fringe benefits
Function
The Head of Regulatory Affairs and Quality Assurance is a key member of our regional Benelux team, reporting to our General Manager Belgium & Luxembourg and the General Manager Netherlands.
You will be responsible for overseeing and leading the RQ Department and associated activities across the BeNeLux cluster. You will provide regulatory and quality strategy, including Responsible Pharmacist role.
You will contribute towards stakeholder value by providing RQ leadership and operational input towards Affiliates strategic and tactical activities.
You will work closely with business unit, market access, and medical affairs departments in the Benelux countries in order to contribute to the achievement of strategic business objectives.
QA Responsibilities :
- Establishment and maintenance of the Quality Management System and Quality Assurance activities to ensure compliance with all regulatory and GxP requirements;
- Management of quality activities related of new product launches and withdraws.
- Supervision of commercial batch release procedures with concerned Authorities, if applicable;
- Integration of global / corporate and Affiliates, as applicable, quality needs and priorities, including representing the Affiliate at the Ipsen Global Quality Events;
- Fostering of the quality culture by encouraging best practices and a high performing quality beyond compliance culture, both from procedural and patient / customer centricity perspectives;
- Support, Oversight and management of any local analytical product release activities (Analytical transfers; Protocol and Report reviews; Facilitate troubleshooting; support any OOS; Product release, if applicable;
- Proactively identification of areas for process improvement and mediate cooperation cross-functionally to effect and implement the Quality System;
RA Responsibilities :
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