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- Tasks: Coordinate regulatory change controls and ensure compliance with high-quality records.
- Company: Kyowa Kirin International, a caring and innovative pharmaceutical company.
- Benefits: Inclusive culture, flexible hours, and opportunities for personal growth.
- Why this job: Make a real difference in people's lives while working on impactful projects.
- Qualifications: Life science background and experience in pharmaceutical regulatory affairs.
- Other info: Dynamic team environment with a focus on teamwork and innovation.
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, 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.
Responsibilities
- When a change/deviation is initiated by GRA, this role will involve working with the record owner (or be record owner), to:
- Identify SMEs
- Co‑ordinate and facilitate meetings
- Work with SMEs to determine change actions (CAs), appropriate timelines and owners.
- Raise CAs in the system (including RA assessment).
- Manage activity/record through to implementation and close out.
- Acting as RA CC window person point of contact.
- Accountable for ensuring that the contact request is accepted and then actioned by RA.
- Working with RA CC SME(s).
- Engage with RA CC SME(s) for pre‑CC initiation discussions in order to understand the proposed change scope and assist Change owner/Initiator in developing the highest quality draft record to be entered into Veeva QMS.
- Ensure smooth transition to the RIMS assigned Event Owner (EO).
- Raising reg activities
- Managing progress of record through RIMs ensuring all activities are completed, in accordance with SOPs and timelines are met.
- Assisting in gathering of data for metrics reporting.
Qualifications
- Life science qualification or other relevant qualifications for role 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 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. No agencies please.
GRA Change Control Coordinator in Marlow employer: Kyowa Kirin International plc.
Contact Detail:
Kyowa Kirin International plc. Recruiting Team
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 understanding KKI's values: Teamwork, Commitment to Life, Innovation, and Integrity. Show how your experience aligns with these values, and you'll stand out as a candidate who truly fits the culture.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to refine your answers. The more comfortable you are, the better you'll perform when it counts.
✨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 KKI team.
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 is tailored to the GRA Change Control Coordinator role. Highlight relevant experience in regulatory affairs and any specific skills that match the job description. We want to see how you can make a difference at KKI!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about making people smile through your work. Share examples of how you've demonstrated teamwork, commitment, and innovation in your previous roles.
Showcase Your Skills: Don’t forget to highlight your analytical and problem-solving skills in your application. We’re looking for someone who can manage change controls effectively, so give us examples of how you've tackled similar challenges before.
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, it shows us you’re serious about 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 and change control processes. Familiarise yourself with the specific responsibilities of a GRA Change Control Coordinator, as well as the key values of Kyowa Kirin International. This will show that you're not just interested in the role, but that you understand how it fits into their mission to make people smile.
✨Showcase Your Teamwork Skills
Since teamwork is one of KKI's core values, be prepared to discuss examples of how you've successfully collaborated with others in past roles. Think about times when you coordinated with SMEs or facilitated meetings, and be ready to share those experiences. Highlighting your ability to work well with others will resonate with their culture.
✨Demonstrate Your Problem-Solving Abilities
In this role, you'll need strong analytical and problem-solving skills. Prepare to discuss specific challenges you've faced in previous positions and how you approached them. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it clear how your actions led to positive outcomes.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! This shows your genuine interest in the role and the company. You might want to inquire about the team dynamics, ongoing projects, or how KKI measures success in this position. Thoughtful questions can leave a lasting impression and demonstrate your enthusiasm for the opportunity.