Regulatory Affairs Expert with Global Pharmaceutical Industry Knowledge

Vor 6 Tagen


Sachsen, Deutschland Planet Pharma Vollzeit

About the Role:

We are seeking an experienced Regulatory Affairs Manager to join our team at Planet Pharma, a global leader in CDMO services. Based in Saxony, Germany, this role will play a crucial part in ensuring compliance with national and international regulations, guidelines, and drug approval laws.

Key Responsibilities:

  • Develop, implement, and oversee regulatory processes and requirements in pharmaceutical development.
  • Provide regulatory guidance and ensure requirements are met for dossier preparation and submissions.
  • Collaborate with internal project teams, international customers, and partners to align regulatory efforts.

Main Requirements:

  • Extensive experience in Regulatory Affairs, particularly with APIs, drug products, and radiopharmaceuticals.
  • In-depth knowledge of pharmaceutical regulations and approval processes in the USA and EU.
  • Proficiency in DMF/ASMF and clinical trial product requirements.
  • Strong expertise in drug approval processes and project management.
  • Degree in Pharmacy, Chemistry, Biology, or a related field.

About You:

You have a strong understanding of pharmaceutical regulations and approval processes in the USA and EU. You possess excellent communication skills and are able to collaborate effectively with cross-functional teams.

What We Offer:

  • A competitive salary of €80,000 - €100,000 per year.
  • The opportunity to work with a global leading CDMO services company.
  • A dynamic and collaborative work environment.

About Us:

Planet Pharma is a global staffing agency that provides recruitment services for the pharmaceutical industry. We offer a unique platform that enables us to work compliantly in 30+ countries.



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