Associate Director, Regulatory Affairs

Shionogi Europe; United Kingdom; On-site; GBP 80,000 - 100,000; Full time

Job summary

A global pharmaceutical leader in the UK is searching for an Associate Director, Regulatory Affairs. In this strategic role, you will lead regulatory submissions, ensuring compliance and successful product development. The ideal candidate will have substantial experience in Regulatory Affairs, particularly with EMA procedures. Strong project management and communication skills are essential. This position offers the opportunity to make a significant impact on public health and contribute to innovative healthcare solutions.

Qualifications

• Experience in Regulatory Affairs within the pharmaceutical industry, covering both development and marketed products.
• Demonstrated success in leading EMA centralized procedures.
• Strong knowledge of EU regulatory procedures and post-marketing requirements.

Responsibilities

• Lead regulatory submissions and interactions with European agencies.
• Oversee post-marketing regulatory activities and lifecycle management.
• Manage CTA strategies and submissions.
• Provide regulatory expertise to project teams.

Skills

Regulatory Affairs expertise

Project management

Communication skills

Interpersonal skills

Problem-solving

Education

University degree in life sciences

Job description

Shape the Future of Regulatory Excellence with Shionogi

At Shionogi, we are dedicated to protecting the health and well-being of people worldwide. As a global pharmaceutical leader, we are driven by science, innovation, and a deep sense of responsibility to public health. Join us in our mission to deliver life-changing treatments by ensuring robust regulatory strategies and compliance across Europe.

Why Join Shionogi?

Shionogi offers a collaborative, agile, and purpose-driven environment where your expertise can make a real impact. We value autonomy, adaptability, and operational excellence. This is a unique opportunity to contribute to a company expanding its footprint in Europe, with a strong focus on regulatory innovation, cross-functional collaboration, and patient-centric solutions.

We are seeking a proactive and experienced Associate Director, Regulatory Affairs to join our team in London. This role offers the chance to lead and shape regulatory activities for our portfolio, ensuring successful product development, approvals, and lifecycle management.

About the Role

You will play a pivotal role in overseeing global and EU regulatory activities for assigned product/s, providing strategic guidance and support to project teams, and ensuring compliance with all relevant regulations. You will work closely with colleagues in Europe, Japan, and the US, leading regulatory submissions, agency interactions, and cross-functional projects.

Responsibilities

• Lead and support regulatory submissions (MAAs, Scientific Advice, PIPs) and interactions with European agencies (EMA, MHRA).
• Oversee post-marketing regulatory activities, including variations and lifecycle management.
• Manage CTA strategies and submissions, including vendor oversight.
• Provide regulatory expertise to cross-functional project teams.
• Mentor and guide team members, ensuring best practices and compliance.
• Contribute to the development and optimization of regulatory processes and SOPs.

What Are We Looking For?

We are seeking a hands-on and strategic professional who can thrive in a fast-paced, global environment. The ideal candidate will combine technical expertise with strong problem-solving and communication skills.

Requirements

• Experience in Regulatory Affairs within the pharmaceutical industry, covering both development and marketed products. With demonstrated success of leading or directing an EMA centralised procedure process.
• Strong knowledge of EU regulatory procedures (CP, DCP, MRP) and post-marketing requirements.
• Excellent project management, communication, and interpersonal skills.
• Being able to demonstrate working collaboratively in an international matrix environment, managing multiple priorities.
• Fluency in English (oral and written).
• University degree in life sciences.

Join Us

Join Shionogi and be part of a team that is shaping the future of healthcare with purpose. We offer a dynamic and supportive environment, opportunities for growth, and the chance to make a lasting impact on public health. Apply now and help us ensure that innovative treatments reach the patients who need them most.