Regulatory Affairs AssociateKYOWA KIRIN LIMITEDAmsterdamNL2021-05-07
WE PUSH THE BOUNDARIES OF MEDICINE.
LEAPING FORWARD TO MAKE PEOPLE SMILE
Everything we do at KKI, is rooted in the idea of leaping forward to make people smile. We are committed to innovation, for the benefit of the patients who count on us to support them. From medicines for rare and underserved diseases, to the support families need when facing a life-changing diagnosis – our team is proud of all we deliver, but also humble in knowing how much more needs to be done. By listening to patient stories, we gain a better understanding of the obstacles patients and their families face – so we can work to better meet their unique needs. The real proof of our impact is in the smiles we see on patients’ faces, when we have helped answer a need, or improved their well-being through our work. While the journey is not easy, it is one that is filled with purpose. To meet the expectations of our patients and to truly deliver on our Commitment to Life, we are continually looking for people who embrace this spirit. We are committed to providing a culture that offers both inspiration and reward – in terms of compensation and in work satisfaction. And in turn, we want people who’ll bring their unique ideas and diverse approaches, while also aligning to our ultimate goal of making people smile. If this sounds like a company that aligns with your values, we’d love for you to join us in our efforts.
Kyowa Kirin International is an equal opportunities employer.
Regulatory Affairs Associate
Kyowa Kirin Pharma B.V. Amsterdam
Post-licensing regulatory activities associated with ensuring that all Kyowa Kirin’s marketed products are in compliance with applicable legislation and business requirements.
Compliance with relevant regulatory legislation and guidelines.
Representation of regulatory affairs at project team meetings for defined projects or products, providing information, feedback and strategic advice.
Co-ordination of the regulatory activities associated with project team plans.
Preparation, attendance and follow up of meetings with Regulatory Agencies (e.g. requests for scientific advice on defined projects, including the generation of briefing documents and minutes).
Preparation of regulatory submissions, including applications for marketing authorisations, ready for peer review and publishing.
Co-ordinate the provision of information requested by regulatory authorities.
Co-ordinate communication between Regulatory Affairs, regulatory authorities, licensing partners and affiliate regulatory affairs contracts, as required.
Acting on new safety information received, as appropriate, in a timely manner.
Personal development and training.
Life science qualification with solid experience in regulatory affairs in the pharmaceutical industry
Sound regulatory knowledge of European and national regulatory regulations and guidelines and/or knowledge and experience of working with partners in overseas territories.
Can work independently and with limited supervision.
Kyowa Kirin Core Competencies: Results Oriented, Sense of Urgency and Flawless in Execution.
Good negotiation, verbal and written communication and interpersonal skills
Good analytical and problem-solving skills
Good organizational and project management skills and attention to detail
Ability to understand and present scientific arguments
In return for your talent, we will provide support through smart working, adopting best practice, deploying the latest technology and ongoing personal development. Plus: