Scientific Project Coordinator

4 days ago

Acharnes, Attica, Greece beBeeCareer Full time

Our mission is to offer a flexible, fully scalable, qualitative, and cost-effective product development in a wide range of dosage forms.

To realize our ambitious goals, we need people who are innovators, believe in the values of respect and cooperation and are ready to commit to a company that wants to penetrate new markets, leverage international business development opportunities, and enter contract manufacturing deals.

We are looking for a CMC Supervisor (at Polydendri site.)

Responsibilities:

  • Coordination on the compilation of the Common Technical Document (CTD) dossiers
  • Supervision of the implementation of EU regulations and ICH guidelines in the compilation of the CTD dossiers
  • Overseeing CMC-wise projects under development
  • Design of regulatory strategy for dossier submission
  • Coordination of responses to questions raised during assessment of the product dossier by Authorities
  • Coordination and collaboration with clients on collection of documentation required for dossier submission
  • Review of CTDs of pharmaceutical products

Requirements:

  • Bachelor's degree in sciences (preferably Pharmacy or Chemistry)
  • Fluency in English both written and oral
  • Excellent computer literacy (MS Office)

Preferred Qualifications:

  • Previous professional experience of at least 5 years in a pharmaceutical company in field of dossier compilation
  • Ability to multitask
  • Capacity to cope with deadlines
  • Excellent teamwork skills

Benefits:

  • Work in a friendly and challenging environment
  • Competitive salary
  • Private insurance
  • Personal development opportunities

The ideal candidate will be responsible for leading multiple cross-functional projects related to product development, working closely with various departments such as Regulatory Affairs, Quality Assurance, and Research & Development.

The successful candidate will have a strong background in pharmaceutical science, excellent analytical and problem-solving skills, and ability to work effectively in a fast-paced environment.

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