Senior Manager, Regulatory Affairs EU

Description

Shape the Future of Healthcare with Shionogi

At Shionogi, we are dedicated to improving the health and well-being of people around the world. As a leading pharmaceutical company, we are committed to innovation, excellence, and making a positive impact on global healthcare. Join us in our mission to shape the future of healthcare and make a difference in the lives of millions.
Why Choose Shionogi?

Shionogi offers a dynamic, collaborative work environment where you can grow your career and contribute to ground breaking healthcare advancements. We value diversity, inclusion, and the unique perspectives that each team member brings. At Shionogi, you will have the opportunity to work with talented professionals, engage in meaningful projects, and be part of a company that is at the forefront of medical innovation.
For this role, we aim to develop the right individual to independently manage their own projects, gradually increasing their levels of responsibility and autonomy.
About the Role

As a Senior Manager in Regulatory Affairs for the EU, you will be instrumental in supporting EU projects, primarily focusing on development initiatives with some post-marketing responsibilities. You will collaborate closely with the EU Project Leads, receiving guidance and direction to ensure project success. Additionally, you will engage with the Global Regulatory Lead within a matrix structure, contributing to a broader regulatory strategy. Your responsibilities will include:
Collaborating with cross-functional teams to develop and execute regulatory strategies for new product development in the EU.
Leading the CTA submission process, managing responses to Health Authorities, and overseeing CRO vendors to ensure compliance with EU regulations.
Supporting the preparation of major regulatory documents such as MAAs, CHMP Scientific Advice, and PIPs, and responding to Health Authorities' queries.
Ensuring effective liaison across the organization to optimize regulatory strategies for post-marketing licensing requirements within the EU.
Assisting with preparation for Health Authority inspections and independent audits.
Supporting thorough technical review of regulatory documents prior to submission.
What are we looking for?

We are seeking an experienced and detail-oriented individual with the following attributes:
Experience in Regulatory Affairs within the pharmaceutical industry, with solid experience in development (CTAs, ODDs, PIPs, PRIME) and some post-marketing experience.
Above country experience, ideally in Europe with the EMA.
Excellent interpersonal skills with the ability to lead, interact with, focus, and drive consensus among individuals from a variety of cultures and disciplines.
Ability to work well within a matrix environment, build team relationships, and interface in a global team environment at all levels of management.
Proven ability to plan, effectively coordinate, and lead activities simultaneously on multiple projects, all with tight time deadlines.
Ability to work effectively under pressure and under strict timelines.
Fluency in English, both oral and written communications.
Join Us

If you are driven to make a tangible difference, please apply. Together, we can forge a path to a healthier world.
Location

London, UK or Amsterdam, The Netherlands, dependent on candidate.
#J-18808-Ljbffr