At a Glance
- Tasks: Coordinate change controls and regulatory assessments to ensure compliance and quality.
- Company: Join Kyowa Kirin, a caring and inclusive pharmaceutical company.
- Benefits: Flexible working hours, travel opportunities, and a supportive team environment.
- Other info: Great opportunity for career growth in a dynamic and impactful industry.
- Why this job: Make a real difference in healthcare while developing your regulatory skills.
- Qualifications: Life science background preferred but not essential; strong communication and problem-solving skills required.
The predicted salary is between 30000 - 40000 € 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.
A junior regulatory professional, responsible for managing and coordinating GRA change controls (CC) and regulatory impact assessments by working with record owners and SMEs to define actions, timelines, and ownership. Oversee change control activities end‑to‑end in QMS and RIMs, ensuring high‑quality records, timely completion, and compliance with SOPs. Serve as the primary RA change control point of contact, support or act as the Regulatory Execution Owner (RAEO), raise regulatory activities, track progress, and contribute to metrics reporting.
Key Responsibilities
- Identify SMEs and co-ordinate and facilitate meetings to determine change actions, timelines and owners.
- Raise Change Actions in the system and manage records through to implementation and close out.
- Act as RA CC window person point of contact, ensuring contact requests are accepted and actioned by RA.
- Engage with RA CC SMEs for pre-CC initiation discussions to understand proposed change scope and assist in developing high quality draft records for Veeva QMS.
- Support or act as RAEO within RIM, raising regulatory activities and managing progress from initiation to close out.
- Assist in gathering data for metrics reporting and oversee collaboration with partners/vendors for assigned projects.
- Lead and support process improvements when operational or strategic issues are identified.
- Ensure personal and team compliance with relevant global regulatory legislation, guidelines and internal procedures.
- Escalate potential risks and issues according to agreed processes.
- Provide RA support and/or RA lead for GxP inspections/audits as required.
Position Requirements
- Graduate from college/university - Life science qualification nice to have but not essential.
- Ability to travel (local and international) with overnight stays.
- Flexibility of working hours.
- Good verbal and written communication and interpersonal skills.
- Good analytical and problem-solving skills.
- Good organisational skills and attention to detail.
- Ability to understand and present basic scientific arguments.
Kyowa Kirin International is an equal opportunity employer.
GRA Change Control Coordinator employer: Kyowa Kirin
At Kyowa Kirin International, we pride ourselves on being an inclusive employer that prioritises the well-being of our employees and the communities we serve. Located in the picturesque towns of Marlow and Galashiels, we offer a supportive work culture that fosters professional growth through continuous learning and development opportunities. Our commitment to making a difference is reflected in our collaborative environment, where every team member's contributions are valued, ensuring that you can thrive while helping us deliver life-changing solutions.
StudySmarter Expert Advice🤫
We think this is how you could land GRA Change Control Coordinator
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Kyowa Kirin. A friendly chat can open doors and give you insights that might just help you stand out.
✨Tip Number 2
Prepare for interviews by practising common questions related to regulatory affairs. We recommend role-playing with a friend or using online resources to get comfortable with your responses.
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you've managed projects or coordinated teams. This will highlight your ability to oversee change control activities effectively.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in being part of the Kyowa Kirin family.
We think you need these skills to ace GRA Change Control Coordinator
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the GRA Change Control Coordinator role. Highlight relevant experiences and skills that match the job description, especially in regulatory affairs and change control processes.
Craft a Compelling Cover Letter:Your cover letter should tell us why you’re passionate about this role and how your background makes you a great fit. Use specific examples to demonstrate your problem-solving skills and attention to detail.
Showcase Your Communication Skills:Since good verbal and written communication is key for this position, make sure your application reflects this. Keep your language clear and concise, and don’t forget to proofread for any errors!
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to track your application status directly!
How to prepare for a job interview at Kyowa Kirin
✨Know Your Stuff
Make sure you understand the basics of regulatory affairs and change control processes. Brush up on relevant legislation and guidelines, as well as the specific responsibilities of a GRA Change Control Coordinator. This will help you answer questions confidently and show that you're genuinely interested in the role.
✨Showcase Your Communication Skills
Since this role involves coordinating with various stakeholders, it's crucial to demonstrate your verbal and written communication skills. Prepare examples of how you've effectively communicated in past roles, especially in situations where you had to explain complex information clearly.
✨Be Ready for Problem-Solving Questions
Expect questions that assess your analytical and problem-solving abilities. Think of scenarios where you've identified issues and implemented solutions, particularly in a regulatory or compliance context. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to change control and regulatory compliance. This shows your enthusiasm for the role and helps you gauge if the company culture aligns with your values. For example, ask about their process for handling regulatory audits or how they support continuous improvement in their operations.
