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Freelance Regulatory Affairs Consultant - REMOTE

Job Work from home
Posted 24 Mar 2024
Work experience
6 to 10 years
Full-time / part-time
Full-time
Job function
Degree level
Required languages
English (Fluent)
Dutch (Fluent)

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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 Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, 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.

This is a freelance remote position and the candidate will work from home.

Job Description

This is a freelance remote consulting position to help a global, European pharmaceutical company with EU and Global Regulatory Affairs.

The work may include, but is not limited to:

  • HQ function with coordination of Regulatory Affairs activities towards local affiliates/partners in Europe and RoW.
  • Operational regulatory project management.
  • Compilation of submission dossiers, writing and reviewing regulatory documents.
  • Coordinate local submissions of variations, e.g. in connection to the harmonization of specifications or updates to product information and labeling.
  • Provide regulatory expertise and guidance on procedural and documentation requirements.
  • Respond to questions from health authorities.
  • Regulatory advice.
  • Cooperation with other functions within the organisation, such as supply chain.

Qualifications

  • MSc in Pharmacy, or equivalent.
  • Excellent understanding of registration procedures and requirements as well as product life cycle management from regulatory affairs perspective. To have knowledge about regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.
  • Strong project management skills.
  • Having an open eye for the needs of the customers and the ability to adjust to these needs.
  • Able to work with deadlines and solving issues in a pragmatic and proactive way.
  • Being able and willing to dig into the details yet keeping an eye on the overall goal of the project.
  • At least 6 years of experience in Regulatory Affairs from the pharmaceutical industry, preferably from a headquarter level.

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