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- Tasks: Support regulatory submissions and collaborate on innovative pharmaceutical projects.
- Company: Kyowa Kirin International, a caring and inclusive pharmaceutical company.
- Benefits: Flexible working hours, travel opportunities, and a supportive team environment.
- Why this job: Make a real difference in patients' lives while growing your career in regulatory affairs.
- Qualifications: Life science qualification and some experience in pharmaceutical regulatory affairs.
- Other info: Join a dynamic team that values teamwork, innovation, and integrity.
The predicted salary is between 36000 - 60000 £ per year.
At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity.
Job Purpose
A regulatory professional (developing to an experienced level), responsible for delivering on tasks/processes/products/projects. Supports the Regional Regulatory Lead (RRL) for global products and/or early/mid phase projects and/or lead for regional products.
Key Responsibilities:
- Supports the creation of regional RA submission strategy for assigned licensed products/development projects while ensuring alignment with regional/global product strategy/guidance to optimise regulatory outcomes and maximise product value.
- Collaborate closely with cross functional departments to ensure development and/or lifecycle management opportunities are identified and incorporated into regulatory strategy.
- Execute regional regulatory strategy under close supervision.
- Lead/manage regulatory submissions for assigned development projects/products with supervision, including managing the preparation and submissions of Wave 2 Marketing Authorisation Applications (MAA).
- Ensure maintenance of marketing authorisations including follow-up of commitments as a condition of approval for assigned products under supervision.
- Manage/support regulatory timelines, interactions and regulatory activities with external organizations as needed, for assigned products/development projects.
- Ensure region label is aligned with CCDS (where applicable).
- Collaborate/support RA activities with partners/vendors and ensure compliance with relevant legislation and guidelines for products/development projects assigned (where applicable).
- Ensure compliance with relevant regulatory legislation, guidelines and internal procedures.
- Escalate potential regulatory risks and issues according to agreed processes.
- Support out-licensing activities.
- Provide RA support for GxP inspections/audits as required.
Qualifications
Life science qualification with experience in pharmaceutical regulatory affairs. Ability to travel (local and international) with overnight stays. Flexibility of working hours. Good verbal and written communication and interpersonal skills; developing negotiations skills. Good organisational skills and attention to detail.
Regulatory Affairs Associate - Based in GALASHIELS employer: Kyowa Kirin International plc.
Contact Detail:
Kyowa Kirin International plc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Associate - Based in GALASHIELS
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Kyowa Kirin. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by knowing your stuff! Research KKI’s values and recent projects. Show them you’re not just another candidate; you’re someone who truly gets what they’re about.
✨Tip Number 3
Practice your pitch! Be ready to explain how your skills in regulatory affairs can help KKI push boundaries. Keep it concise and impactful – you want to leave them wanting more!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the team at KKI.
We think you need these skills to ace Regulatory Affairs Associate - Based in GALASHIELS
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Associate role. Highlight relevant experience in pharmaceutical regulatory affairs and any life science qualifications you have. We want to see how your background aligns with our mission to push the boundaries of medicine!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about making a difference in healthcare and how you embody our values of teamwork, commitment, innovation, and integrity. Let us know what makes you the perfect fit for KKI!
Showcase Your Skills: Don’t forget to highlight your good verbal and written communication skills, as well as your attention to detail. These are crucial for the role, so give us examples of how you've used these skills in past experiences. We love seeing real-life applications!
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s straightforward and ensures your application goes directly to us. Plus, it shows you’re keen on joining our team at KKI!
How to prepare for a job interview at Kyowa Kirin International plc.
✨Know Your Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in the pharmaceutical sector. Familiarise yourself with the key responsibilities listed in the job description and be ready to discuss how your experience aligns with them.
✨Showcase Your Team Spirit
Since teamwork is a core value at Kyowa Kirin, think of examples from your past experiences where you collaborated effectively with others. Be prepared to share how you contributed to a team project and what the outcome was.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills and ability to handle regulatory challenges. Prepare by thinking through potential scenarios you might face in the role and how you would approach them, especially regarding compliance and risk management.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready about the company culture, regulatory strategies, or upcoming projects. This shows your genuine interest in the role and helps you determine if it's the right fit for you.
