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Senior / Principal Regulatory Affairs Specialist (m/f/x)

  • Location: Zug, Zug, Canton of Zug, Switzerland
  • Salary: Swiss Franc130000 - Swiss Franc160000 per annum + negotiable per year
  • Job Type:Contract

Posted 2 months ago

  • Sector: Pharmaceutical
  • Contact: Sebastian Gotzler
  • Contact Email: s.gotzler@sciproglobal.de
  • Start Date: asap
  • Expiry Date: 14 August 2021
  • Job Ref: RA_2021_22_1626357720

Senior / Principal Regulatory Affairs Specialist (m/f/x) | Zug (CH) | Pharma & Medical Devices

In this role you will perform all necessary regulatory activities for medicinal products in the DACH region (DE, AT, & CH) + Liechtenstein. You will establishe, develop and manage the Swiss Authorized Representative office on behalf of the mother company. You will ensure timely notification of all medicinal products / medical devices to Swissmedic in compliance with national legislation. Develop processes to ensure that all products in the DACH region are maintained in compliance throughout the product lifecycle. Partnering closely with the commercial organisation in the region, acts as the primary point of contact for all medicinal products in the DACH region.

What will your activities as "Senior / Principal Regulatory Affairs Specialist" involve?

  • Managing the Swiss Authorized Representative office

  • Performing Health Authority notifications

  • Reviewing and approving advertising and promotional materials

  • Conducting Change evaluations for impact to the DACH region

  • Supporting tenders

  • Working with distributors of medical devices & medicinal products

  • Managing materiovigilance activities

  • Verifying packaging and labelling artwork meets local requirements

  • Supporting Field Safety Corrective Actions

  • Staying current on national and European legislation

  • Participating in regulatory policy and intelligence activities

  • Supporting regional/global projects as applicable

What does the position as "Senior / Principal Regulatory Affairs Specialist" offer you?

  • Salary: very competitive compensation package

  • Contract type: unlimited

  • Vacation: 30 days / year

  • Working time: 40 hours / week

  • Accessibility: Very good transport connections by public transport; sufficient parking spaces available

  • Start date: At the next possible date

What requirements should you bring as "Senior / Principal Regulatory Affairs Specialist"?

  • Bachelor's degree in science, engineering, law, pharmacy or another related field

  • Advanced degree preferred (MS, PharmD, Ph.D. or equivalent)

  • At least 5 years of experience in regulatory affairs, quality or compliance with Medicinal Products in Europe

  • Knowledge of legislation for Medical devices (93/42/EEC) and (EU 2017/745)

  • Knowledge of Swiss medical devices ordinance

  • Capability to react quickly to changes in the regulatory environment

  • Self-motivated, detail-oriented and capable of working independently

  • Demonstrated ability in analytical reasoning and critical thinking skills

  • Fluent written and spoken English and German

  • Experience working in cross-functional teams

Information about our customer:

Our client is a leading global healthcare company. In addition to contact lenses and surgical instruments, the company also produces pharmaceuticals and is uniquely positioned internationally with this range of products. The company employs more than 12,000 people worldwide, and more than 700 at the second largest company location in Berlin.

Does this position appeal to you? Then you should apply right away! If you would like to receive further or alternative positions, I would also be pleased to receive your application!

I look forward to your application!