Assistant to VP Regulatory Affairs International and Regulatory Affairs Coordinator

Employer
Location
Zug, Switzerland
Salary
Competitive salary and benefits
Posted
Jun 02, 2018
Closes
Aug 02, 2018
Education
BS
Career Fair Category
Career Fair

Assistant to VP Regulatory Affairs International and Regulatory Affairs Coordinator (ZUG- Temporary Contract)  

There is nothing conditional about what we do.
Or who we are.
Or how we treat you.
We do what’s right.
We put science for patients first,
disrupting the model to go beyond
the concepts of conventional care.
We don’t treat a condition.
We treat people & partners.
We care to change the future.

Job Responsibilities:

Regulatory Affairs

  • Support the RA team administratively in the development of documents e.g. application forms, briefing packages, pediatric investigational plans/amendments, orphan applications, various module 1 documents, content planners, templates, etc.
  • Electronic archiving of Health Authority correspondence in VEEVA system.
  • Organize internal and external meetings for which RA team is lead (e.g. RA international team meetings, International health interaction, scientific advice meetings, meetings to support submissions).
  • Subscribe to conference/training courses for RA international team.
  • Maintain memberships and licenses for regulatory networking groups
  • Support further development and maintenance of SharePoint for Regulatory Affairs International

Health Authority Interaction

  • Review and draft application forms and cover letters. Prepare various eCTD submission documents, create draft Eudralink messages.
  • Ensure appropriate archiving in regulatory document management systems.
  • Support compilation of briefing packages for meetings with International health authorities.

General Administrative Regulatory Affairs Support

  • Proactive administrative support to the Regulatory Affairs International Department
  • Coordinate and manage complex Executive calendar and  organisation of business travel
  • Process expense reports, manage departmental invoices and support on relevant Annual Operating Plan (budget activities)
  • Generate documents and follow up as required.
  • Responsible for administration, filing and archiving of critical department documents.
  • Act as a coordinator of information. This includes organising meetings and assisting to create the agenda and minutes when appropriate (lead in organisation of Regulatory Affairs International Team (RAIT) meetings.
  • Manage and filter phone calls, mail and email, clarifying/highlighting required actions and responses. 
  • Welcome RA guests and business partners. 
  • Develop and refine administrative procedures using technology to streamline processes.
  • Independently drive and complete assigned tasks/projects. 

Requirements:

  • Proven experience of working in an international environment (preferably within the life sciences). 
  • Understanding of Regulatory Affairs (within life sciences) preferred.
  • Successful experience as an Executive Management Assistant or Team Assistant preferred.
  • Experience of working in a start-up environment an advantage.
  • Excellent user of Microsoft Office (Outlook, Word, Excel and PowerPoint) and well as knowledge with SharePoint platform
  • Practical business-oriented solution approach. 
  • Well organized and able to prioritize and manage changing workload and meet deadlines. 
  • Very strong in communication and managing business relationships. 
  • Able to stay calm when workload is high. 
  • Takes ownership of given responsibilities. 
  • Attention to detail, flexible, proactive, assertive, committed and reliable. 
  • Demonstrates unquestionable integrity and professionalism. 
  • Shown the ability to work successfully in multi-cultural teams. 
  • Demonstrated the ability to build strong relationships with key stakeholders. 
  • Business fluent in English (verbal and written). 
  • Other languages, particularly fluent German, a plus.

TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

FOR MORE INFORMATION, PLEASE CONTACT US AT careers2@tesarobio.com

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