246 days ago on searchapp-695.umantis.com

Regulatory Affairs Director Switzerland

AurigaVision AG

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 Please refer to JobSuchmaschine in your application

Regulatory Affairs Director Switzerland

1179

 

Englisch

 

Vollzeit / Temps complet

Festanstellung

 

 

Our customer is a Global Pharmaceutical company in the area of Zug.
For the Swiss subsidiary we are seeking to recruit a

Regulatory Affairs Director Switzerland
Regulatory Affairs Director Switzerland

 

In order to enable success in the role, key areas of focus will include:

  • Drive the regulatory vision and provide high quality, strategic leadership in executing the Regulatory activities in Switzerland and link commercial strategies to filing plans in the decision making process.
  • Act as a key partner with the Commercial and Medical functions in the local Management Teams
    in Switzerland.
  • liaise with the General Manager Switzerland as well as with EU Regulatory Sciences leadership to ensure
    proactive communication and full alignment with commercial strategies.
  • Drive effective and consistent communications with Swiss Health Authorities and explore innovative
    regulatory practices. Drive regulatory processes in line with Business and Research & Development
    objectives to ensure timely registration of new products, line extensions, and life cycle management of products, and as such obtain marketing authorisations for medicinal products with high medical need.
  • Lead interactions with Regulatory Authorities regarding clinical trials applications (CTAs) in line with
    company policies and practices and the local legislation.
  • Proactively manage all regulatory launch activities and provide key pre-launch support. Manage the
    local development and implementation of effective processes and quality standards for advertising and
    promotion control systems in line with policies.
  • Ensure compliance to Swiss Health Authority requirements regarding GDP
    in accordance with local
    legislation, support Qualified Person for GDP for Switzerland
  • Act as a key partner with the country medical department, market access department, and Marketing
    departments in the local management of the life of the marketed products.
  • Develop the necessary external network with Health Authorities and Trade Associations in Switzerland.
  • Enable a high performing organisation and culture; provide guidance for development and performance
    in a strong regulatory team.


 

Qualifications:
  • Master of Science degree, preferably medical, pharmaceutical or other life sciences.
  • Broad Swiss regulatory experience in leading country regulatory activities.  
  • Expertise in leading the development of the Regulatory function in the Country, ensuring compliance and alignment with the R&D objectives and the Country objectives.
  • Proven track record creating working systems and processes and implementing plans to achieve superior execution and to provide to our customers/patients the highest-quality pharmaceuticals. 
  • Demonstrated success as a credible, influential and respected spokesperson able to develop effective cross-functional partnerships. 
  • Exposure to international regulatory environment. 
  • Proven ability to navigate effectively in a multi-cultural environment with the ability to communicate across all levels and functions of a global organization.
  • Significant experience in leading a Regulatory team.
  • Proven experience and ability to manage people and coordinate groups. Consistently develop staff through mentoring and coaching, ensures ongoing succession for key positions within the country.

    Are you interested in this challenging role in a fast-moving global environment? Then we look forward to your application
    by mail with reference number 1179 to jobs@aurigavision.com or online on www.aurigavision-career.com. Full discretion
    guaranteed.

     


 

 

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AURIGAVISION AG
Tamara Vonlanthen
Baarerstrasse 139
6300 Zug
jobs@aurigavision.ch