Regulatory Affairs manager

☞ Randstad Switzerland

View: 172

Update day: 25-04-2024

Location: Basel Basel-Stadt BS

Category: Legal / Contracts

Industry: Staffing Recruiting Biotechnology Research Pharmaceutical Manufacturing

Position: Associate

Job type: Full-time

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Job content

For our client, a growing company in the pharmaceutical industry, we are looking for a :

Regulatory Affairs manager

Location: Basel

Contract: Permanent

Main Objective

Support the Head of regulatory affairs in ensuring that the company remains compliant with established regulatory procedures.

Your Main Responsibilities
  • To prepare regulatory documents or submissions in coordination with internal and external stakeholders in order to ensure that marketing authorizations, renewals, amendments of existing MAs and dossier updates are carried on in compliance with regulatory requirements
  • To take part in the worldwide regulatory activities for the Endo franchise
  • To provide regulatory input into preparation of submission relevant documents
Your Profile
  • Degree in medicine, health care, life sciences or related fields
  • Experience (around 5 years) in registration procedure
  • Knowledge in the rare disease field is a plus
  • Experience in international context
  • Knowledge of EMA and FDA procedure
  • In-depth knowledge of ICH and applicable legislation
  • Solution-oriented mindset
  • Pragmatism and ability to manage ambiguity
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Deadline: 09-06-2024

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