Associate Regulatory Affairs (m/f/x) - EU Regulatory Procedural Management

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.

In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

For our headquarters in Munich we are seeking highly qualified candidates to fill the position of:

Associate Regulatory Affairs (m/f/x) - EU & AMELA Regulatory Procedural Management

The position:

With emphasis on development and regulatory life cycle management, RPMs provide regulatory procedural support and guidance to assigned projects for all regulatory pre- and post-authorisation activities in a manner that is scientifically sound, commercially viable, and in accordance with regulatory standards. In this role, RPMs ensure a smooth run of regulatory procedures as well as regulatory compliance. The support is directed towards Regional Strategists for their designated projects and activities.
The primary objective of the RPM is to ensure the successful and timely achievement of regulatory project milestones and deliverables. The RPM contributes to the development of the RPM group by sharing best practices and swiftly resolving process and operational challenges. Additionally, the RPM focuses on the continual enhancement of RPM processes, prioritizing quality, reliability, consistency across projects, and efficiency.

This position is located at Daiichi Sankyo Europe’s Headquarters in Munich.

Roles and responsibilities:

•    Manage regional regulatory submissions.
•    Ensure effective tracking of regulatory information in global system (commitments, HAQ, HAM, submission/approval dates, etc.).
•    Support or lead development of regulatory documents with guidance from Regional Strategist.
•    Provide regulatory support in HA meeting preparation, RRT activities, GRT meetings.
•    Strengthen RA function infrastructure by building global and cross-project processes and standards.
•    Other regional specific deliverables, which may include for example: support of artwork, post-approval commitment tracking, variation assessment/submission, annual report, etc.

Qualification, personal skills and professional experience:

•    University degree in Pharmacy, Life Sciences, Health, Medicine or related filed. Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD; a TOPRA diploma or Master Degree in Regulatory Affairs or further pharmaceutical specialization).
•    Experience in Regulatory Affairs with an emphasis on regulatory pre-submission and post-approval activities and preparation of new Marketing Authorisations in Europe (EU and non-EU) and International.
•    Knowledge of relevant European and International laws, regulations, guidelines and other requirements for human medicinal product marketing authorisations and maintenance is essential.
•    Experience of working in a global regulatory environment in interdisciplinary teams and interacting with regulatory authorities.
•    Proven ability to plan, coordinate, and lead activities simultaneously on multiple projects.
•    Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation.
•    Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner.
•    Solution and detail-oriented; well organised and self-motivated.
•    Excellent written and oral communication skills in English.

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.

For more information: www.daiichi-sankyo.eu