Regulatory Affairs Manager Benelux

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Job description We are Janssen, part of J&J, with more than 250 companies located in 60 countries around the world. We are dedicated to addressing and solving some of the most significant unmet medical needs of our time. Our portfolio focuses on hematology, oncology, immunology, neuroscience, infectious diseases, rare diseases, and cardiovascular and metabolic diseases. Motivated by our dedication to patients, we bring innovative products, services, and solutions to people all over the world. Janssen-Cilag is currently recruiting a Regulatory Affairs Manager Benelux to lead accelerated broad patient access from a regulatory perspective for Janssen’s key brands. Your role Act as the local contact for Regulatory Affairs with both our internal (local and regional) and external (national Health Authorities) partners, ensuring compliance with all applicable regulatory requirements in Benelux. The role reports to the Head of Regulatory Affairs Benelux, who in turn reports to the Medical Director Benelux. More in detail you will Be dedicated to (a set of) Therapeutic Areas for products in development and new products (centralized procedure products only, no MRP/NP). Keeping oversight of and contributing to all regulatory activities for the assigned products (new marketing authorization applications, line extensions, variations, labeling changes, CMC changes, MAH transfers, safety issues, license withdrawals) Monitoring the external Benelux environment (new and revised regulatory requirement) and ensuring your products are 100% compliant. Be part of the Benelux cross-functional product teams (CVT) working closely with commercial, market access, medical, governmental affairs, supply, quality, and others Working with CVT and local Health Authorities to deliver cross-functional objectives such as early access programs (CUP/MNP/SPR), product information (SmPC), packaging materials (patient leaflet/carton/label), additional risk minimization measures (aRMM/RMA/controlled distribution), new product launch and product issues (DHPC, ESI) Translating regulatory environment developments (incl. competitive intelligence) into relevant actions for the CVT, enabling an optimized strategy. Represent local Regulatory Affairs in regional Regulatory Affairs Functional Networks (EMEA/G7). Working with EMEA Regulatory Affairs to organize local Health Authority meetings (scientific advice, pre-submission meetings) Ensuring that, where any local issues are identified as potentially impacting regulatory strategy, these are highlighted to EMEA Regulatory Affairs to ensure that the regulatory strategy can be implemented efficiently. Ensuring a smooth transition of all Benelux activities and responsibilities following an MAH transfer of a centrally authorized product. Participate in or lead G7 Expert Network for assigned products and provide strategic regulatory input. Depending on your experience and interest, represent Janssen in Trade Association working groups (pharma.be/VIG/APL) Working with other companies to shape the external environment Be a member of working groups (minimum safety stock, ePIL, patient-friendly product information) Qualifications What you will need to succeed We are looking for a person with a passion for the industry and an interest in growth and development. You are driven, enthusiastic, positive while challenging the status quo You have strong communication and presentation skills You are able to convert complex data into simple messages You have a bachelor’s degree in life science (required) or a degree in pharmacy (preferred). You have a minimum of three years of experience in Regulatory Affairs in industry, Health Authorities, or equivalent (required). You have knowledge of the EU regulatory framework (required) and the way it is implemented in Benelux (preferred). You have experience in working with centralized procedure products, local implementation of risk management plans and launches (preferred). Fluency in Dutch and English, French is a plus. What is in it for you You will get all the support you need to make your job successful. At Janssen, we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Janssen, a highly motivated team, eager to maintain Janssen’s leading position. Janssen offers a competitive remuneration package and a dynamic work environment. The employers of the Johnson & Johnson family value diversity and inclusion. We are committed to building diverse teams that reflect both the patients and the partners we support. We strive to create an inclusive work environment where our people feel at home and are given the space to realize their full potential. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Primary Location Belgium-Antwerp-Beerse- Other Locations Europe/Middle East/Africa-Netherlands-North Brabant-Breda Organization Janssen-Cilag Netherlands (8345) Job Function Regulatory Affairs Requisition ID 2206025415W