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Job Details

Drug Regulatory Affairs Manager

Company: CTC Resourcing Solutions
Location: Zug area, Switzerland
Reference: 895233-P
Closing Date: 08 Mar 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

We are seeking a Regulatory Affairs Manager to work closely with global and local colleagues from DRA and other relevant line functions to define strategy and execute regulatory Submissions to Swissmedic for Safety Label Updates and new Indications.

Requirements:

Reference Number:         895233-P

Type of placement:         Contract, 6 months

Location:                        Switzerland, Zug area

 

Main Responsibilities:

  • Work closely with global and local colleagues from DRA and other relevant line functions to define strategy and execute regulatory Submissions to Swissmedic for Safety Label Updates and new Indications
  • Maintain regulatory dossier of a range of products, including submission of Module 3 CMC packages. Compilation and Submission of maintenance submissions
  • Keep renewals up-to-date and submits applications for renewals if required
  • In collaboration with team, tracks and documents regulatory activities in respective tools, trackers and databases
  • Manage printed text material according to the quality standards and timelines set by Swissmedic, internal SOPs and KPIs, and other stakeholders. Involves the relevant local and global line functions as appropriate
  •  Coordinate the process of artwork creation and approval and performs text comparisons of artwork components, including final release of Ready for Print (RfP) and approval of printed packaging material sheet (PPMS)
  • Ensure  that submissions to health authority are done in accordance with Swissmedic regulatory standards and internal standard operating procedures or working practices - within appropriate timeframes, including PSURs, DSURs and RMPs, notifications on marketing and de-registration status of registered products. In case of transfers of Marketing Authorizations to another entity or third party supports transfer application and manages transfer of regulatory dossier
  • Create and maintain the Swiss-specific parts of regulatory dossiers including Information for Professionals and Patient and Packaging Information as well as National Succinct Statement
  • Support integration and re-organizations affecting organizational structures and/or product portfolio as appropriate
  • Ensure appropriate archiving of regulatory relevant Swissmedic documents, including correspondence
  • Report any Adverse Event or Technical Quality Complaint within 24h from in accordance to the valid local SOPs

 

Qualifications and Experience:

  • Master/ PhD degree in life science (ideally in pharmaceutical sciences) would be preferred
  • More than 3 years of experience in Regulatory Affairs in pharma environment
  • Knowledge and experience with Swissmedic regulations
  • Experience in Regulatory Affairs, Label Changes and CMC submissions
  • Native or Business fluent in German and English (written and spoken)
  • Relevant working/residency permit or Swiss/EU-Citizenship required

Apply for this job: Drug Regulatory Affairs Manager

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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