Regulatory Affairs Manager
This is an excellent opportunity for an established and highly experienced Regulatory Affairs professional to join us at this pivotal time, offering a rare opportunity to support the regulatory activities for a new product across Europe and emerging KKI territories, with additional future activities into the US. Kyowa Kirin International plc. (KKI), in partnership with Ultragenyx, is launching Burosumab, a recombinant, fully humanised monoclonal antibody against the phosphaturic hormone fibroblast growth factor 23 (FGF23), targeting X-Linked Hypophosphatemia - a rare genetic disorder of phosphate metabolism leading to a spectrum of painful abnormalities including rickets, osteomalacia, spinal stenosis and osteoarthritis. About you: This role merits an individual with a high level of Regulatory Affairs acumen; who has excellent leadership and cross functional management skills, the confidence and ability to work independently and be a decision maker. To be successful in this role you will have: Expert Regulatory Affairs experience, preferably with orphan drugs in Europe and the US Excellent negotiation, verbal and written communication and interpersonal skills The ability to think strategically and develop global regulatory strategy whilst balancing local/affiliate needs Good analytical and problem solving skills Good organisational and project management skills and high attention to detail Key accountabilities and responsibilities include: Management of compliance with relevant regulatory legislation and guidelines Defining project and product regulatory strategy in line with commercial and company strategy, consulting with appropriate departments when necessary Liaising with regulatory authorities Provision of expert regulatory advice to other departments in the organisation, and regulatory support to licensing partners in the EU and other territories Ensure communication of changes in business-critical legislation/regulatory guidance, and project and product regulatory status to appropriate internal and external personnel in a timely manner Pro-actively identify potential obstacles to approval of regulatory submissions and manage the resolution of issues Regular contact with regulatory authorities and external consultants working on behalf of Kyowa Kirin as required. The ability to understand and present complex scientific arguments Benefits: Competitive salary Pension scheme Private medical insurance Other voluntary benefits include: Childcare Vouchers, Bike to Work Location: This role can either be based in our Galasheils Head Office in the Scottish Borders, or from a London base at our office in Chertsey. About us: Kyowa Kirin International is going through an exceptional time. Burosumab is one of three product launches expected over the next three years and further new product development, combined with excellent international growth rates; we are providing a great platform for today and our future. Kyowa Kirin International plc is owned by Kyowa Hakko Kirin Co., Ltd (KHK) of Japan. Founded in 1949, KHK has a successful track record in Japan and is now expanding globally. Our highly successful product portfolio, enviable pipeline and active Business Development group provides a wealth of products in the therapeutic areas of Oncology, CNS and Nephrology. With three key anti-body therapies in late stage development Kyowa Kirin is setting the scene for transformative growth. Kyowa Kirin International is an equal opportunities employer.