Manager (m/w/d) Regulatory Affairs

Daiichi Sankyo Europe GmbH; Schlieren; Vor Ort; CHF 90’000 - 120’000; Vollzeit

Zusammenfassung

A global pharmaceutical company in Zürich is seeking a Regulatory Affairs Manager to manage regulatory activities for its products in Switzerland. The ideal candidate will have 5-8 years of experience working with Swissmedic, knowledge of Swiss laws, and strong communication skills in German and English. This role offers the chance to contribute to innovative therapies and drive regulatory submissions. Join a team committed to improving patient outcomes in a diverse and inclusive environment.

Leistungen

Culture of mutual respect

Continuous learning opportunities

Commitment to inclusion and diversity

Qualifikationen

• 5 to 8 years experience in Regulatory Affairs with Swissmedic in the pharmaceutical industry.
• Deep knowledge of Swiss national laws and guidelines for medicinal product marketing authorization.
• Native level German and proficient in English, with additional languages as a plus.

Aufgaben

• Manage regulatory activities for assigned products in Switzerland.
• Act as primary contact for Swissmedic, driving negotiations.
• Develop regulatory strategies in collaboration with teams.

Kenntnisse

Interpersonal skills

Detail-oriented

Multifunctional coordination

Excellent communication

Ausbildung

University Degree in Pharmacy, Medicine, Life or Natural Sciences

Jobbeschreibung

Company Overview

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

Manage regulatory activities for assigned Daiichi Sankyo products in Switzerland, including new marketing authorisations, lifecycle management and support of launch preparation.

Roles and 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.

Personal Skills And Professional Experience

• University Degree Degree in Pharmacy, Medicine, Life or Natural Sciences.
• 5 to 8 years 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.
• Deep knowledge of Swiss national laws, guidelines and other requirements for innovative 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 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.