Senior Manager Regulatory Affairs (m/f/d)

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to be an innovative global healthcare company contributing to the sustainable development of society, we are shaping a healthier, more hopeful future for patients, their families, and society.

Purpose of the function

LOCATION: Uxbridge, UK

To provide regulatory guidance and support and execute regulatory activities in the UK for assigned marketed products and development projects.

Responsibilities

• Serve as the primary regulatory liaison and point of contact with the MHRA for an assigned product portfolio.
• Support or lead negotiations on regulatory matters and coordinate meetings and teleconferences.
• Collaborate with European and Global Regulatory Teams to develop regulatory strategies and provide guidance to internal and external stakeholders across Daiichi Sankyo.
• Act as the regulatory lead for the DSUK affiliate (and/or UK alliance partners), supporting Brand Teams, Medical, Market Access, and Supply.
• Support regulatory activities and submissions in Ireland when required, including acting as absence cover.
• Advise on national submission requirements and identify deficiencies needing resolution.
• Prepare gap analyses comparing documentation against EU and global requirements.
• Plan, lead, and manage regulatory submissions to the MHRA during product development and lifecycle management.
• Coordinate preparation and review of regulatory documentation for submission, ensuring sign-off prior to submission.
• Prepare national documents and support labeling and artwork implementation.
• Maintain product licenses for approved products, initiate and oversee changes, and ensure regulatory compliance.
• Keep the EU headquarters updated on submission status and implementation progress.
• Monitor UK/MHRA regulations, directives, guidelines, and initiatives; communicate key changes and trends to stakeholders.
• Develop or revise SOPs and SOIs as needed.
• Mentor and guide internal and external team members, including consultants and service providers, as applicable.
• Assign and prioritize work while managing competing deadlines.
• Provide regulatory advice on interventional and non-interventional clinical trials in the UK when required, in collaboration with European Regulatory Team and CROs.
• Provide launch support and advise on supply matters to ensure patient access to medicines.
• Represent Regulatory Affairs and/or Daiichi Sankyo in internal and external interactions with functional groups, project teams, partners, authorities, and industry associations.
• Build strong relationships with stakeholders at the UK affiliate and EU headquarters.
• Lead or support initiatives to improve processes, functionality, and adaptation to evolving regulatory requirements.

Education & Experience

• Education Required: Degree in Pharmacy, Medicine, Life or Natural Sciences, PhD, post-doctorate or professional experience in pre-clinical research or clinical development, a TOPRA diploma or Master Degree in Regulatory Affairs or other relevant specialization.
• Required Experience: Working experience with MHRA, Experience in Oncology.
• Preferred Experience: Working experience in pharmaceutical industry, in Clinical Research Organizations or at a regulatory authority with proven experience in regulatory affairs with an emphasis on regulatory pre-submission and post-approval activities and preparation of new marketing authorizations in the EU and UK. Experience with Project Orbis.

Skills And Additional Requirements

• Deep knowledge of UK/MHRA national laws, regulations, guidelines and other requirements for human medicinal product marketing authorization and maintenance is essential.
• Excellent interpersonal skills.
• Ability to communicate and work across functions effectively in a multinational organization to accomplish results.
• Be detail-oriented, well organized and self-motivated.
• Proven ability to plan, coordinate and lead activities simultaneously on multiple projects.
• Very high ethical standards.
• Understanding of development and life-cycle management of drugs and regulatory processes including the regulatory requirements and processes in Europe.
• Ability to interact and communicate effectively with regulatory authorities and stakeholders in a multinational environment.
• Computer proficiency (e.g. MS Office, document management systems, databases), excellent written and verbal communication skills in English.
• Fluent in another European language (desirable).

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.