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- Tasks: Support regulatory submissions and collaborate on innovative pharmaceutical projects.
- Company: Kyowa Kirin International, a caring and inclusive pharmaceutical company.
- Benefits: Flexible working hours, travel opportunities, and a supportive team environment.
- Why this job: Make a real difference in patients' lives while developing your career in regulatory affairs.
- Qualifications: Life science background with experience in pharmaceutical regulatory affairs.
- Other info: Join a culture of teamwork, innovation, and integrity in Galashiels.
The predicted salary is between 30000 - 48000 £ per year.
Join to apply for the Regulatory Affairs Associate role at Kyowa Kirin International plc.
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 our 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.
Overview
Regulatory Affairs Associate at Kyowa Kirin International plc, Scotland, Galashiels.
Job Purpose
A regulatory professional (developing to an experienced level), responsible for delivering on tasks/processes/products/projects. Supports the Regional Regulatory Lead (RRL) for global products and/or early/mid phase projects and/or lead for regional products.
Key Responsibilities
- Supports the creation of regional RA submission strategy for assigned licensed products/development projects while ensuring alignment with regional/global product strategy/guidance to optimise regulatory outcomes and maximise product value.
- Collaborate closely with cross functional departments to ensure development and/or lifecycle management opportunities are identified and incorporated into regulatory strategy.
- Execute regional regulatory strategy under close supervision.
- Lead/manage regulatory submissions for assigned development projects/products with supervision, including managing the preparation and submissions of Wave 2 Marketing Authorisation Applications (MAA).
- Ensure maintenance of marketing authorisations including follow-up of commitments as a condition of approval for assigned products under supervision.
- Manage/support regulatory timelines, interactions and regulatory activities with external organizations as needed, for assigned products/development projects.
- Ensure region label is aligned with CCDS (where applicable).
- Collaborate/support RA activities with partners/vendors and ensure compliance with relevant legislation and guidelines for products/development projects assigned (where applicable).
- Ensure compliance with relevant regulatory legislation, guidelines and internal procedures.
- Escalate potential regulatory risks and issues according to agreed processes.
- Support out-licensing activities.
- Provide RA support for GxP inspections/audits as required.
Qualifications
- Life science qualification 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 negotiation skills.
- Good organisational skills and attention to detail.
Regulatory Affairs Associate - Based in GALASHIELS 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 Regulatory Affairs Associate - Based in GALASHIELS 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 about how your experiences align with these principles and be ready to share!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to get comfortable answering common questions. The more you practice, the more confident you'll feel when it’s your turn.
✨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 joining the team at Kyowa Kirin.
We think you need these skills to ace Regulatory Affairs Associate - Based in GALASHIELS in Marlow
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Associate role. Highlight relevant experience in pharmaceutical regulatory affairs and any life science qualifications you have. We want to see how your skills align with our mission to make a difference!
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 our team at Kyowa Kirin. Keep it concise but impactful, showing us your commitment to innovation and integrity.
Showcase Your Communication Skills: Since good verbal and written communication is key for this role, make sure your application reflects that. Use clear language and structure your documents well. We appreciate attention to detail, so proofread for any typos or errors before hitting send!
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 proactive and genuinely interested in joining our team in Galashiels!
How to prepare for a job interview at Kyowa Kirin International plc.
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in the pharmaceutical sector. Familiarise yourself with relevant legislation and guidelines that KKI follows. This will show that you're not just interested in the role but also understand the industry's nuances.
✨Showcase Your Team Spirit
Since teamwork is a core value at KKI, be ready to share examples of how you've successfully collaborated with others in past roles. Highlight any cross-functional projects you've been part of, as this will demonstrate your ability to work well with diverse teams.
✨Prepare for Scenario Questions
Expect questions that ask how you'd handle specific regulatory challenges or project timelines. Think about potential scenarios related to regulatory submissions and how you would approach them. This will help you articulate your problem-solving skills effectively.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about KKI's approach to regulatory strategy or how they manage compliance with evolving regulations. This shows your genuine interest in the company and the role, plus it gives you valuable insights into their operations.
