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Regulatory Affairs Manager - Swissmedic Submissions - Home Based

Job Title: Regulatory Affairs Manager - Swissmedic Submissions - Home Based
Contract Type: Contract
Location: Zürich, Switzerland
Industry:
Salary: Rates TBC
Start Date: 2020-02-24
Reference: BH-124120
Contact Name: Kevin Kendaru
Contact Email: Kevin.Kendaru@nesgt.com
Job Published: February 17, 2020 20:28

Job Description

Regulatory Affairs Manager – Swissmedic Submissions – Home Based

We have an opportunity for an experienced Regulatory Affairs Manager to join a well-renowned pharmaceutical company for a 12 month contract. You will be supporting the company with a high number of new submissions to Swissmedic. With an extensive portfolio and pipeline, you will be joining at an exciting time of development and will be directly impacting their performance.

Main Responsibilities:
  • Compile and submit dossiers (NDA and variations) to obtain and maintain Swiss registrations for new and branded products in a range of therapeutic areas
  • Be responsible for regulatory compliance of dedicated portfolio
  • Manage communication with Swissmedic and interact continuously with internal stakeholders
  • Inform and consult other departments within the company on regulatory strategy, variations and regulatory requirements pertaining to gaining authorisation in Switzerland
  • Analyse and implement changing Swissmedic requirements
  • Adhere to timelines set by the Swiss health authorities
  • Coordinate the implementation of the approved variations with internal stakeholders
 
Requirements:
  • 6-8 years’ experience within pharmaceutical regulatory affairs, submissions of MAA and maintaining existing marketing authorisation and lifecycle management, particularly in Swiss submissions
  • Deep understanding of Swiss regulations and experience being a key stakeholder in communication with Swissmedic
  • Fluent German and English
  • Strong work ethic and able to work independently
  • Ability to keep all stakeholders informed with strong communication and influencing skills
  • Relevant working / residency permit or Swiss /EU-Citizenship
This is an excellent opportunity for a role that offers flexibility and autonomy. You will have the opportunity to use to expertise to influence the regulatory strategy for the foreseeable future.
Interested? Please get in touch with an updated CV to kevin.kendaru@nesgt.com , and I will be happy to discuss this opportunity and others in Regulatory Affairs in Switzerland.
 

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