At a Glance
- Tasks: Coordinate change controls and regulatory assessments to ensure compliance and quality.
- Company: Join Kyowa Kirin, a caring and innovative pharmaceutical company.
- Benefits: Flexible hours, travel opportunities, and a supportive team environment.
- Other info: Dynamic role with opportunities for personal and professional development.
- Why this job: Make a real difference in patients' lives while growing your career.
- Qualifications: Recent graduate with a passion for regulatory affairs and life sciences.
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. 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.
Responsibilities
- Coordinate and facilitate change/control activities when a change/deviation is initiated by GRA, working with record owners to identify SMEs, determine change actions, raise CAs, and manage records through implementation and close out.
- When a change is initiated in QMS, act as the RA change control point of contact, ensuring that requests are accepted and actioned by RA, and work with RA CC SMEs to prepare high‑quality draft records for Veeva QMS.
- Support or act as RAEO within RIM, raising regulatory activities, managing progress through RIMs, ensuring completion of activities in accordance with SOPs, and assisting with metrics reporting.
- Oversee collaboration with partners/vendors for assigned projects/products, ensuring compliance with legislation and guidelines during selection and onboarding.
- Lead and support process improvements for operational or strategic issues.
- Ensure personal and team compliance with relevant global regulatory legislation, guidelines and internal procedures.
- Escalate potential risks and issues per agreed processes.
- Provide RA support and/or lead for GxP inspections/audits as required.
- Collaborate closely with other sub‑functions and functions to share strategy, knowledge and best practice.
Qualifications
- Graduate from college/university; life‑science qualification nice to have.
- 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 negotiation skills.
- Good analytical and problem‑solving skills.
- Good organisational skills and attention to detail.
- Ability to understand and present basic scientific arguments.
- Maintain Kyowa Kirin Core Competencies: Results Oriented, Sense of Urgency and Flawless in Execution.
- Enthusiasm and good work ethos are mandatory.
Kyowa Kirin International is an equal opportunity employer. No agencies please.
GRA Change Control Coordinator employer: Kyowa Kirin International
At Kyowa Kirin International, we pride ourselves on fostering a culture of inclusivity and innovation, making it an exceptional place for professionals in the pharmaceutical industry. Our commitment to employee growth is evident through our supportive environment that encourages bold actions and collaboration, ensuring that every team member can contribute to life-changing solutions. Located in a vibrant area, we offer flexible working hours and opportunities for international travel, enhancing both personal and professional development.
StudySmarter Expert Advice🤫
We think this is how you could land GRA Change Control Coordinator
✨Dive into Pharma Networks
Join online communities like PharmaForum or LinkedIn groups dedicated to pharma professionals. Engaging in discussions will not only boost your visibility but can also lead to valuable connections who might tip you off about entry-level gigs, like the one at Kyowa Kirin International.
✨Volunteer for Industry Events
Look out for local pharmaceutical conferences or seminars—these are goldmines for making connections and learning what's trending in the industry. Volunteering can also give you a foot in the door and informal chats with recruiters or current employees from companies like Kyowa Kirin International.
✨Utilise University Career Services
If you’re still in uni or even recently graduated, tap into your university’s career services. They often have connections with companies looking for bright new interns, especially in pharma—don’t miss out on those resources.
✨Show Off Your Passion and Knowledge
Craft a stellar online presence that reflects your enthusiasm for the pharmaceutical industry—write articles or share insights on platforms relevant to the field. When applying for an entry-level position at Kyowa Kirin International, you’ll stand out with demonstrated knowledge on current industry trends.
We think you need these skills to ace GRA Change Control Coordinator
Some tips for your application 🫡
Show Off Your Science Skills:In the pharmaceutical industry, it's essential to flaunt your scientific knowledge. Make sure to highlight any relevant coursework or projects from your studies that showcase your understanding of drug development or pharmacology in your CV. If you've handled lab work or research projects, mention those too!
Highlight Relevant Certifications:If you’ve got any certifications related to the pharmaceutical field—think Good Clinical Practice (GCP) or any lab safety training—be sure to include those in your application. These can set you apart and show that you’re serious about entering the industry.
Craft a Compelling Cover Letter:Your cover letter is your chance to express your passion for the pharmaceutical industry and your enthusiasm for the role at Kyowa Kirin International. Share your motivation for wanting to work in this field and any relevant experiences that set the stage for your entry-level career.
Tailor Your CV for Entry-Level:As you’re applying for an entry-level role, focus on transferable skills that show your potential—like teamwork, effective communication, or analytical thinking. Make sure to keep your CV clear and concise, drawing on your education and any internships, even if they weren't in pharma, to illustrate your readiness for the job!
How to prepare for a job interview at Kyowa Kirin International
✨Know Your Pharma Basics
Brush up on the key concepts and processes within the pharmaceutical industry. Being able to discuss drug development, regulatory processes, or clinical trials can really impress those at Kyowa Kirin International since it shows we have a foundational understanding of the field.
✨Highlight Relevant Coursework and Projects
This is your chance to shine a light on any relevant studies or projects from uni that directly relate to the role. Talk about case studies, lab work, or any experience with pharmaceutical tools or software; this will showcase our hands-on learning and readiness to jump into the role at Kyowa Kirin International.
✨Prepare for Technical Questions
Expect some technical questions related to pharmacology, biochemistry, or even basic lab techniques. It's crucial we can talk through methodologies or explain processes confidently; practice might involve reviewing common concepts or having a friend quiz us on them.
✨Show Enthusiasm for Learning
As it's an entry-level role, displaying a thirst for knowledge can set us apart. Talk about how we keep up with industry trends or how we've engaged with pharmaceutical news or journals; enthusiasm can really seal the deal with the hiring team at Kyowa Kirin International.
