Regulatory Affairs Associate - Based in GALASHIELS

Kyowa Kirin International; Galashiels; On-site; GBP 30,000 - 40,000; Full time

Job summary

A global pharmaceutical company is seeking a Regulatory Affairs Associate in Galashiels, Scotland. This role involves supporting regulatory submissions and collaborating with cross-functional teams to enhance product lifecycle management. Ideal candidates will hold a life science qualification and have experience in regulatory affairs. Strong communication, organizational skills, and an ability to manage regulatory timelines are essential. This position offers the opportunity to contribute to impactful projects in a dynamic environment.

Qualifications

• Experience in pharmaceutical regulatory affairs.
• Ability to travel locally and internationally.
• Flexibility of working hours.

Responsibilities

• Support creation of regulatory submission strategy.
• Collaborate with cross-functional departments.
• Execute regional regulatory strategy.
• Lead/manage regulatory submissions.
• Ensure maintenance of marketing authorisations.
• Manage regulatory timelines and activities.
• Ensure compliance with relevant legislation.

Skills

Communication skills

Organisational skills

Negotiation skills

Attention to detail

Education

Life science qualification

Job description

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.

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.

Responsibilities

• Supports the creation of regional RA submission strategy for assigned licenced 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

Position Requirements

• 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.