Senior Regulatory Affairs Operations Manager – WilsonHCG EMEA Ltd. – Leiden

Senior Regulatory Affairs Operations Manager About Astellas At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing 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. About this job In the position of the Senior Regulatory Affairs Manager you will be involved in strategic and execution-focused interactions with multiple regional health authorities and other Astellas functions such as Pharmacovigilance, Marketing Operations, Data Science, Supply Chain, Manufacturing and other areas within Medical & Development. As a Senior Regulatory Affairs Operations Manager you will: Support the accuracy and completeness of global regulatory product data and other regulatory information by authoring and/or reviewing the quality documents and other reference material and that adhere to the relevant data standards and industry best practices Deliver reports sharing Regulatory information with cross-functional stakeholders including Pharmacovigilance, Medical Affairs, Development Operations, Finance and senior and top management Support the daily operation of the global Regulatory Information Management system including data entry, quality control and metrics Support controlled vocabulary management across Regulatory Affairs systems, in conjunction with the Data Integration and Optimization Regulatory Operations team Oversee the process and ensure the creation and transmission of data-centric regulatory submissions such as XEVMPD and IDMP Essential Knowledge & Experience: Proven experience in a regulatory operations role or similar position associated with regulated processes and content in the pharma industry Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed Ability to work independently with minimal direction and coordinate priorities and tasks within project teams, committees, etc. to attain group goal Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members Preferred Knowledge & Experience: Advanced degree (e.g., Masters, PhD, etc,) Experience with managing IT systems Demonstrated proficiency using document management, submission publishing, registration management, labelling, quality control and/or change control systems Basic understanding of information taxonomies, master data management or other structured data constructs Basic understanding of data warehousing, data lakes and reporting/analytics platforms or concepts Education/Qualifications: Bachelor’s degree (science or technology is preferred) Additional information: Full time We offer: A challenging and diversified job in an international setting Opportunity and support to continuous development Inspiring work climate

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