Project Manager - Regulatory Affairs CMC (Immunology)

Project Manager - Regulatory Affairs CMC (Immunology)

ProPharma Group

Stockholm, Sweden

Job Description

Specialist with a scientific background in CMC process and product development. Experience in science, translational research, CMC development, and development strategies covering immunology. This is a fulltime 6 months freelance project.

Tasks

  • Strategic advice.
  • Drafting and review of documents.
  • Defining strategy for drug development projects.
  • Participating as expert in Process & Product development teams.
  • Experience with national and EMA scientific advice, US FDA (Pre)IND meetings.
  • Strategic input in coordination of up- and downstream development.
  • Document and project management.

Qualifications

Qualified candidates must have:

  • Academic degree in a life science field.
  • Minimum 3 years of experience in a CMC position within the pharmaceutical industry or government Health Agency.
  • Excellent communication skills (oral and written) in English and Swedish.
  • Excellent in writing scientific and technical texts.
  • Being able to transfer knowledge to others.
  • Being organized and pay attention to detail.
  • Being able to work on multiple projects, prioritize and meet project deadlines.
  • Good analytical, listening, and negotiation skills.
  • Proactive, decisive, flexible.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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