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Consultant Regulatory Affairs - CMC Experience needed

Posted 26 Mar 2024
Work experience
2 to 5 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
Dutch (Fluent)

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Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in the United States, United Kingdom, Netherlands, German, Sweden, Australia, and Japan, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

Who we are looking for:

You are an entrepreneur, able to think and act at a scientific level, who is able to quickly adjust to different working environments. A high degree of flexibility in working with different companies and disciplines is required. An open eye for the needs of your customers and the ability to adjust to these needs is essential. At least 3-5 years of experience in regulatory affairs within biotech, pharmaceutical industry or government agency is a requirement. With these experience you are curious about new opportunities for yourself, the client and ProPharma Group, a self-starter and quick learner with excellent communication skills. Your English is fluent and you’re confident in writing scientific/regulatory deliverables.

Being a consultant you will have the opportunity to work in a wide variety of projects and companies. Assignments on small molecules or high-tech (biological) products may cover all aspects of regulatory affairs such as:

  • Providing strategic advice related to (clinical) regulatory affairs.
  • Drafting and review of regulatory documents.
  • Defining regulatory strategy for drug development projects.
  • Participating as regulatory expert in clinical product development teams.
  • Experience with national and EMA scientific advice, US FDA (Pre)IND meetings.
  • Submission of marketing authorization applications, clinical trial applications and IND/NDAs..
  • Writing of CTD overviews and summaries.
  • Strategic input in and writing and coordination of regulatory deliverables such as orphan drug applications and PIPs.
  • Document and project management.

Qualifications

Qualified candidates must have:

  • Hold an academic degree in a life science, medical, or paramedical field;
  • Excellent communication skills (oral and written) in English;
  • Proven experience in Regulatory Affairs and/or Medical Writing;
  • Strong CMC experience
  • 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.

Additional Information

Candidate must be legally eligible to work in the Netherlands.

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies

Pharmaceutical
Leiden
Active in 10 countries
89 employees
30% men - 70% women
Average age is 42 years