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- Tasks: Coordinate regulatory change controls and ensure compliance with high-quality records.
- Company: Join Kyowa Kirin, a caring and innovative pharmaceutical company.
- Benefits: Flexible working hours, travel opportunities, and a supportive team environment.
- Other info: Dynamic role with opportunities for personal and professional growth.
- Why this job: Make a real difference in patients' lives 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.
WE PUSH THE BOUNDARIES OF MEDICINE. LEAPING FORWARD TO MAKE PEOPLE SMILE. 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. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.
Job Purpose
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. Enthusiasm and good work ethos are absolutely mandatory.
Key Responsibilities:
- When a change/deviation is initiated by GRA, this role will involve working with the 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.
- 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.
- Ensure smooth transition to the RIMS assigned Event Owner (EO).
- Raising reg activities.
- Managing progress of record through RIMs.
- Assisting in gathering of data for metrics reporting.
Position Requirements
- Graduate from college/university - Life science qualification nice to have but not essential 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
Contact Detail:
Kyowa Kirin International 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, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its values. At Kyowa Kirin, they value teamwork and innovation, so think of examples from your past that showcase these traits. Show them you’re a perfect fit!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to get comfortable with common questions. The more you practice, the more confident you'll feel when it’s time to shine.
✨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 genuinely interested in being part of the Kyowa Kirin family.
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 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 making a difference in the pharmaceutical industry. Share specific examples of how your previous experiences align with our values of teamwork, commitment, and innovation.
Showcase Your Enthusiasm: We love candidates who are genuinely excited about the role! Let your enthusiasm shine through in your application. Mention what specifically draws you to Kyowa Kirin and how you can contribute to our mission of making people smile.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team!
How to prepare for a job interview at Kyowa Kirin International
✨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 any specific tools like Veeva QMS that might be used in the role.
✨Show Your Enthusiasm
Kyowa Kirin values enthusiasm and a good work ethic. Be prepared to share examples of how you've demonstrated these qualities in previous roles or projects. Let your passion for making a difference shine through!
✨Prepare for Teamwork Questions
Since teamwork is a core value at Kyowa Kirin, think of instances where you've successfully collaborated with others. Be ready to discuss how you identify subject matter experts and coordinate efforts to achieve common goals.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready about the company culture, team dynamics, or ongoing projects. This shows your genuine interest in the role and helps you assess if it's the right fit for you.