Consulting & Corporate Strategy

Regulatory Operations Specialist

Not Specified



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.

Regulatory Operations Specialist

Kyowa Kirin International plc Galashiels,Marlow,UK


Job Purpose

Prepare, track and submit Regulatory submissions to EMEA Region health authorities in line with current technical specifications and regional requirements. Maintain processes and procedures for Regulatory submissions and document management.


  • Build and deliver timely and high-quality EMEA and possibly North American regulatory submissions according to the Submission Plan.
  • Act as Subject Matter Expert for EU submissions and continuously keep abreast of regulatory requirements in this area.
  • Demonstrate expert facility with Company systems including document management system, planning and tracking tools, publishing tools and Adobe Acrobat Professional.
  • Strengthen relationships with customers and other stake holders and exhibit an understanding of their needs in order to develop and maintain robust processes.
  • Independently work to resolve technical issues that may impact submission build or logistics of submission delivery to Health Authorities, escalating as appropriate.
  • Proactively identify opportunities and approaches for business process improvement
  • Participate in Project Team meetings as required to maintain knowledge and understanding of upcoming submissions and communicate to Regulatory Operations Team.
  • Provide day-to-day customer support and training for EMEA users as Business Administrator of the global document management system (GRAPES).
  • Assist the Manager, Regulatory Operations in all areas of responsibility, including interpreting and enforcing electronic regulatory submission standards, policies and operating procedure requirements.
  • Identify own training and development needs in conjunction with line manager.


  • Proven success in working in a team
  • Experience with electronic document management systems required.
  • As this can be a sedentary position the individual needs to be able to withstand long periods of sitting.
  • Ability to use VDU equipment.
  • A degree of flexibility needed with regards to rare occasions where working late/early will be required.
  • Occasional travel will be required
  • Kyowa Kirin Core Competencies: Results Oriented, Sense of Urgency and Flawless in Execution.
  • Strong customer service orientation
  • Attention to detail and accuracy are essential.
  • Excellent organisational skills and the ability to work to tight deadlines are essential.
  • Flexibility and the ability to re-prioritise workload are essential due to changing priorities of the team.
  • Open minded, willing to learn, and sound judgement.
  • Excellent verbal and written communication skills.


In return for your talent, we will provide support through smart working, adopting best practice, deploying the latest technology and ongoing personal development. Plus:

  • Competitive salary
  • Bonus
  • Pension scheme
  • Private medical insurance

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…… click apply for full job details

Employment Type Permanent

Advertiser Type Company