Regulatory Affairs Officer
Keyrus Life Science is looking for an Regulatory Affairs Officer to provide strategic and operational regulatory support in the preparation of the submission and during the review of new Marketing Authorization Applications, variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements. You will liaise directly with the Regional Submission Planner to provide input and ensure alignment on the submission plans. You will prepare and organize on the module 1 components as well as the English Product Information (Summary of Product Characteristics, label and leaflet). In terms of collaboration, you will work closely with Regulatory Operations in order to establish the submission timelines of Module 1 components to the National Agencies. In this sense, you will supervise and coordinate the local translation process to ensure the timely submission to the EMA. You will liaise with the competent agencies who will ensure the assessments with the labeling group.
Last but not least, you will also ensure the necessary updates to the regulatory databases and keep up to date with the EU procedural requirements and legislation.
You already gained a minimum of 2 years’ experience in the pharmaceutical industry. You have a very good knowledge of the EU regulatory procedures and development of medicinal products and have a first experience in the European legislation for new marketing authorizations and variations. You are organized, can multitask and have excellent written and verbal skills in English. Written and verbal skills in Dutch is an asset. You know exactly where to look for guidance about required documents/annexes/GMP certificates. Your innovative mindset can demonstrate the ability to evaluate new ideas and propose methods for the practicality and ease of implementation. You understand perfectly the end-to-end pharmaceutical lifecycle and can consider the recent innovations when formulating the recommendations. You evaluate activities and business processes across functions, identifies areas in need for improvement and leads efforts for solution design and implementation. You are able to act as an intermediary across boundaries.
What we offer
At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park Waterloo - Drève Richelle 161 - 1410 Waterloo
- Nijverheidslaan 3, - Strombeek-Bever