Senior Regulatory Affairs Officer

Overview

Are you an enthusiastic Regulatory Affairs (RA) professional looking to work in an RA department located on the same premises as the production facilities for biological medicines? Do you want to play a meaningful role in the eradication of polio worldwide? Then this position at the RA department of Bilthoven Biologicals (BBio) is your opportunity! The RA department manages the regulatory dossiers of all BBio products and ensures that changes in the vaccine manufacturing process are assessed in terms of impact on the regulatory dossier.

When a change in production has impact, the RA department determines the regulatory strategy in consultation with other departments and submits variation applications to the regulatory authorities. The uniqueness of the RA department of BBio is that it is located on the same premises as the GMP production and testing facilities; in other words, there are many direct F2F contacts between the RA colleagues and the colleagues in the production facilities;

as an RA professional, you are literally very close to the action, which is quite unique in the Netherlands. In addition to all activities directly related to vaccine production, the RA department is also responsible for managing artwork, packaging, and product information, ensuring compliance with pharmacovigilance legislation in collaboration with an external pharmacovigilance service provider, and maintaining contact with clients and regulatory authorities worldwide.

There are also very concrete plans to register and market existing BBio products in new EU countries. In addition to existing products, BBio also wishes to register two new products in the EU, making expansion of the RA team a high priority.

• Preparation and submission of regulatory dossiers to obtain new product registrations in countries worldwide
• Maintenance of regulatory dossiers of registered vaccines both nationally and abroad
• Initiation of variations in response to change control procedures, changed regulations, or at the request of authorities, and implementation and coordination of resulting actions
• Critical review of source documents from other departments such as Quality Control (QC), Manufacturing Science & Technology (MS&T) or Production, such as validation, comparability, and stability reports, to ensure these documents are suitable for submission to regulatory authorities
• Participation in projects that have an impact on the regulatory dossier, e.g. new presentations or major changes in the manufacturing process
• Maintenance of contact with the external company that performs the pharmacovigilance tasks on behalf of BBio
• Maintenance and setting‑up of various regulatory IT systems such as XEVMPD, IDMP, PMS, and the creation of eCTD sequences
• Maintenance of internal and external relationships with consultants, agents, and national and overarching regulatory authorities such as the EMA, MEB, and WHO
• Identification and interpretation of changed and/or new laws and regulations for marketing authorizations worldwide
• Provision of (un) solicited advice and responses to questions about the regulatory dossier from other departments
• Coordination of the creation or modification of pharmaceutical artwork, contact with artwork printers
• Determination and set‑up of the regulatory strategy for current and new regulatory procedures, in collaboration with the manager RA
• Represent RA in projects with other departments (including MS&T and M&S) at an early stage, assess impact on product registration procedures in a timely manner
• Collaborate closely with other departments/colleagues such as MS&T, Marketing and Sales (M&S), Quality Control (QC), Quality Assurance (QA) and Qualified Persons (QPs)
• Performing final editing on all regulatory dossier documents
• Writing of RA department procedures

• University working and thinking level, i.e. an MSc. degree in a biomedical discipline or BSc. degree in a biomedical discipline supplemented with significant RA work experience
• Knowledge of international regulatory guidance and marketing authorization procedures for biological medicines, including regulatory dossier granularity and eCTD basic…