At a Glance
- 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.
- Other info: Join a dynamic team that values teamwork, innovation, and integrity.
- Why this job: Make a real difference in patients' lives while growing your career in regulatory affairs.
- Qualifications: Life science qualification and some experience in pharmaceutical regulatory affairs.
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 (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 negotiations skills. Good organisational skills and attention to detail.
Regulatory Affairs Associate - Based in GALASHIELS employer: Kyowa Kirin International plc.
At Kyowa Kirin International, based in the picturesque town of Galashiels, we pride ourselves on fostering a culture of innovation and teamwork that empowers our employees to make a real difference in patients' lives. Our commitment to employee growth is evident through continuous training opportunities and a supportive environment that encourages bold actions and collaboration across departments. Join us to be part of a purpose-driven organisation where your contributions truly matter and where we strive to create a workplace that makes you smile every day.
Contact Details:
Kyowa Kirin International plc. Recruitment Team
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We think this is how you could land Regulatory Affairs Associate - Based in GALASHIELS
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We think you need these skills to ace Regulatory Affairs Associate - Based in GALASHIELS
Some tips for your application 🫡
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✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Kyowa Kirin International plc. that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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