At a Glance
- Tasks: Coordinate change controls and regulatory assessments to ensure compliance and quality.
- Company: Kyowa Kirin International, a caring and inclusive pharmaceutical company.
- Benefits: Flexible working hours, travel opportunities, and a supportive team environment.
- Other info: Join a dynamic team with opportunities for growth and learning.
- Why this job: Make a real difference in healthcare while developing your regulatory skills.
- Qualifications: Life science degree preferred but not essential; strong communication and analytical 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 in Marlow 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 settings 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 in Marlow
✨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 practising common questions related to regulatory affairs. We recommend role-playing with a friend or using online resources to boost your confidence and refine your answers.
✨Tip Number 3
Showcase your problem-solving skills! During interviews, share specific examples of how you've tackled challenges in past roles. This will demonstrate your analytical abilities and fit for the GRA Change Control Coordinator position.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace GRA Change Control Coordinator in Marlow
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the GRA Change Control Coordinator role. Highlight any relevant regulatory affairs experience and showcase your organisational skills, as these are key for the position.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how you can contribute to making a difference at Kyowa Kirin. Don’t forget to mention your problem-solving skills and attention to detail!
Showcase Your Communication Skills:Since good verbal and written communication is essential for this role, make sure your application is clear and concise. Use straightforward language and avoid jargon to demonstrate your ability to communicate effectively.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
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 regulations 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, be prepared to demonstrate your verbal and written communication skills. Think of examples where you've successfully facilitated meetings or communicated complex information clearly. This will highlight your ability to engage with SMEs and manage change actions effectively.
✨Be Ready for Problem-Solving Questions
Expect questions that assess your analytical and problem-solving abilities. Prepare scenarios where you've identified issues and implemented solutions, especially in a regulatory context. This will showcase your critical thinking skills and your ability to handle operational challenges.
✨Emphasise Attention to Detail
In regulatory affairs, attention to detail is crucial. Be ready to discuss how you've ensured high-quality records and compliance in past roles. You might even want to mention any tools or methods you use to stay organised and maintain accuracy in your work.
