Manager Regulatory Affairs (m/f/x)

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.

We are seeking highly qualified candidates to fill the position of:

Manager Regulatory Affairs (m/f/x)

The Position:

The Regulatory Affairs Manager oversees regulatory activities for assigned Daiichi Sankyo products in Switzerland, including new marketing authorisations, lifecycle management, and support of launch preparation. 

Roles & Responsibilities:

•    Act as primary contact person for Swissmedic for assigned products, drive negotiations on regulatory matters.
•    In close collaboration with the European and Global Regulatory Team develop regulatory strategies for Switzerland, advice and provide clear guidance and information to internal and external stakeholders in Daiichi Sankyo. Seek opportunities for timely, accelerated, and effective regulatory submissions. Explore innovative regulatory practices.
•    Advise on national submission matters and any specific additional national requirements, identify deficiencies requiring resolution. Prepare gap analyses of documentation vs. EU and global requirements. 
•    Drive, plan, and manage regulatory activities as submission of new marketing authorisations to Swissmedic and life cycle management. 
•    Maintain Swiss licences for approved products by handling the full regulatory lifecycle including line extensions, labelling and CMC variations, PSUR submissions, renewals etc., provide oversight, and ensure regulatory compliance. 
•    Keep current with, review, and interpret regulatory legislation, guidelines, and initiatives. Communicate important changes and trends within Regulatory Affairs and Swiss affiliate business functions. Design and revise SOPs.
•    Provide launch support and advise on supply questions of medicinal products.
•    Represent Regulatory Affairs and/or Daiichi Sankyo in internal and external interactions and liaise with cross-functional groups at Swiss Affiliate, multidisciplinary local and multinational project teams, and license partners. Build up strong relationship with internal and external stakeholders at the Swiss affiliate and EU head office.
•    Drive projects to enhance the functionality and improve processes of the organization and/or to adapt to the regulatory environment.
 

Education & Professional Experience:

•    Degree in Pharmacy, Medicine, Life or Natural Sciences.
•    Deep knowledge of Swiss national laws, guidelines, and other requirements for innovative human medicinal product marketing authorization and maintenance is essential.
•    Significant working experience (min 5 years) in Regulatory Affairs working with Swissmedic within the pharmaceutical industry with an emphasis on regulatory pre-submission and post-approval activities and preparation of new marketing authorization in Switzerland. 
•    Experience in Oncology and innovative pathways as ORBIS is a plus.
•    Excellent interpersonal skills. Ability to communicate and work across functions effectively in a multinational organization to accomplish results.
•    Be detailed-oriented, reliable, 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. Ability to interact and communicate effectively with regulatory authorities and stakeholders in a multinational environment.
•    Native level German and excellent written and verbal communication skills in English, French and/or Italian is a plus.

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.ch/de