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.