Regulatory Compliance Specialist

vor 1 Monat


Berlin, Berlin, Deutschland Planet Pharma Vollzeit

Job Description:

  • This role involves developing and maintaining a solid understanding of regulatory requirements and available guidance documents and resources.
  • The Regulatory Affairs Manager assists with planning, scientific writing, and critical reviews of submissions to ensure conformance with regulatory requirements.
  • Excellent communication skills are essential for this position, both written and oral.
  • The successful candidate will be able to lead through ambiguity and make decisions based on regulatory requirements while working independently and with cross-functional teams.
  • The Regulatory Affairs Manager acts as product liaison and corresponds with regulatory agencies for submissions and information requests.
  • Assessing manufacturing processes against regulatory filings is a key responsibility in this role.
  • Maintaining awareness of project timelines is crucial for ensuring on-time submissions.
  • Participating in agency meetings is necessary for effectively communicating company positions and understanding agency feedback.

Requirements:

  • A strong biopharmaceutical or regulatory background is required.
  • Experience writing high-quality submission dossiers is essential.
  • German language fluency is preferred.
  • Attention to detail is crucial for success in this role.
  • Ability to interpret, communicate, and strategize is necessary.
  • A strong work ethic is required.
  • Collaboration with different teams and application of experience and 'lessons learned' are important.

Benefits:

  • Competitive salary range $120,000 - $160,000 per year
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment


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