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Job Details

Regulatory Affairs Manager - 12 Month Fixed Term Contract

Company: Kyowa Kirin International plc
Reference: SEJP4H1
Closing Date: 08 Mar 18
Type: Full Time
Salary (£): Competitive

Job Summary:

Excellent opportunity for an experienced Regulatory professional to support a growing organisation during an exciting time


  • Excellent opportunity for an experienced Regulatory professional to support a growing organisation during an exciting time
  • Based at our Global Head Office in Galashiels, Scottish Borders, an hours commute from Edinburgh
  • 12 Month Fixed Term Contract to cover maternity leave

 About you:

To be successful in this role you will have:

  • Expert Regulatory knowledge with extensive industry experience
  • Excellent negotiation and verbal/written communication
  • The ability to think strategically with strong analytical and problem solving skills
  • Good organisational and project management skills and high attention to detail
  • Strong interpersonal skills and the ability to liaise with other internal departments and external contacts

Key accountabilities and responsibilities include:

  • Preparing, reviewing and managing regulatory submissions
  • Liaising with and maintaining records of submissions and communication with regulatory authorities
  • Working cross functionally with relevant departments across the business to provide expert regulatory knowledge
  • Providing regulatory support to licensing partners in the EU and other territories
  • Obtaining costings for regulatory activities
  • Regular contact with regulatory authorities, and consultants working on behalf of Kyowa Kirin


  • Competitive salary
  • Pension scheme
  • Private medical insurance
  • Other voluntary benefits include: Childcare Vouchers, Bike to Work


You will be based at our Head Office in Galashiels, commutable from Edinburgh in less than an hour.

Situated in the beautiful Scottish Borders, the local area provides affordable housing options with great infrastructure in terms of schooling, outdoor activities and transport.

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.

Apply for this job: Regulatory Affairs Manager - 12 Month Fixed Term Contract

Contact Information:

Address:  Head Office
Galabank Business Park, Galashiels , Selkirkshire
Tel:  +44 1896 664000
Website:  Visit Our Web Site

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