Manager Regulatory Affairs

Vor 4 Tagen

Basel, Schweiz Daiichi-Sankyo Europe Vollzeit

To provide regulatory guidance and support and execute regulatory activities in Switzerland for approved products and development projects.

**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, advice and provide clear guidance and information to internal and external stakeholders in Daiichi Sankyo
- 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
- In collaboration with the European and Global Regulatory Team plan, lead and manage regulatory submissions during development and life cycle management to Swissmedic
- Coordinate preparation of and prepare regulatory documents for submission, review regulatory and related documents for sign off prior to submission. This includes all national documents required for the submission and implementation of labelling and artwork
- Maintain licenses 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 and SOIs
- 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 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 with ORBIS is a plus
- 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

**Personal Skills**:

- 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
- Native level German and excellent written and verbal communication skills in English; French and/or Italian is a plus

**Why work with us?**:

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