Regulatory Affairs Specialist

vor 2 Wochen

Biberach an der Riß, Baden-Württemberg, Deutschland GULP – experts united Vollzeit
Regulatory Affairs Associate

We are seeking a highly motivated and experienced Regulatory Affairs Associate to join our team at GULP – experts united. As a key member of our pharmaceutical industry partner's team, you will play a crucial role in ensuring compliance with regulatory requirements and obtaining product approvals.

Key Responsibilities:
  • Coordinate and monitor activities to obtain and maintain product approvals
  • Review country-specific regulatory and normative requirements for product approval
  • Conduct and prepare tests to ensure compliance with legal requirements
  • Develop procedures, sequences, and documentation structures
  • Collaborate with German authorities, internal and external customers
  • Participate in project teams with development, production, and product management
Requirements:
  • University degree in pharmacy, medicine, or natural sciences, ideally a license to practice pharmacy
  • Experience in regulatory affairs and applying for approval of clinical trials
  • Knowledge of approval procedures
  • Excellent knowledge of European and German pharmaceutical legislation
  • Confident knowledge of German and English
  • Strong communication, negotiation, and team spirit skills
  • High motivation and an independent, goal-oriented work style
What We Offer:
  • Attractive salary package with Christmas and vacation bonuses
  • Allowance for company pension scheme after probationary period
  • Reimbursement of travel expenses
  • Up to 30 days' vacation per year
  • Regular team events such as summer parties and Christmas parties
  • Discounts at sports, leisure, and wellness facilities

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