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company_seo_logo Regulatory affairs specialist (f/m/d) 50% [1596]

Standort:

Schweiz, Luzern, Luzern

Branche:

Chemieindustrie

Bereich:

Rechtswesen

Niederlassung: Basel , Streitgasse 20
Datum: 15/06/2022
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At nemensis ag, we connected thousands of applicants with their dream jobs and gave them the opportunity to develop or re-enter the job market. For our client, an international company in Luzern, we are in search for a Regulatory Affairs Specialist (f/m/d).

 

Employment type: Temporary via nemensis ag, 50%

Duration: asap - 31.12.2022

Salary: CHF 52 - 60.- / h gross

 

Your role:

As a Regulatory Affairs Specialist for Switzerland you will be responsible for all RA submission requirements for assigned product portfolio as applicable. You will collaborate with colleagues (1 Director, 2 RA Specialists) to ensure compliance with local laws and regulations, including backing up colleagues. You will be also responsible for other activities (as delegated/assigned by their manager) which may include but are not limited to: review of local RA agreements, participation in audits and inspections and related readiness activities.

 

Your responsibilities:

  • Responsible for execution of local RA processes and activities in alignment with RA systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation.
  • Assist in timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations and global standards.
  • Files, stores, updates and archives regulatory data and documentation in accordance with department and company policies and local requirements.  
  • Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.

 

Your Profile:

  • Health, life science, or medical science degree or equivalent degree.
  • 1-3 year of industry experience in regulatory affairs.
  • Must have a general knowledge of RA regulations within his/her assigned country and be an expert in RA processes/activities.
  • Good communication and time management skills
  • Fluent in English (written and spoken) while proficient (min. B2) in German.

 

We look forward to receiving your application!

For further questions please contact:

Nicolas Gerster, +41 61 205 98 69, nicolas.gerster@nemensis.com

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Vertragstyp:Temporäre Arbeit

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