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Head of Regulatory Affairs

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Biotechnology - Gosselies

Our client is a clinical stage biotech company leading the development of new therapies for rare diseases affecting the central nervous system. The company is backed by strong international investors.

The company’s leading program is currently in an ongoing phase II/III clinical trial in EU and US, with results expected in 2020. In the upcoming months, our client is planning to launch a clinical trial for a second orphan indication. For more information about the company, please contact us via recruitment@pahrtners.be

Founded in Spain, the company is opening a subsidiary in Gosselies (Belgium). In order to strengthen the team in Belgium, we are currently looking for a (m/f):

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Head of Regulatory Affairs

Responsibilities:

As a Head of Regulatory Affairs, you serve as a key and active member of the director leadership team, making sure regulatory objectives are met. You lead the organization on regulatory affairs, coordinate with regulatory advisors and mentors and provide training and interpretation of global regulatory requirements to all company personnel.

Your main responsibilities are:

  • Provide regulatory strategy and lead all regulatory interactions.
  • Author or co-author all regulatory documents (background documents, orphan designations, other) with appropriate support as needed.
  • Serve as liaison with EMA/CHMP.
  • Coordinate all FDA interactions with the support of US personnel (contractor or internal).
Profile:
  • Master’s degree in life sciences or equivalent through experience.
  • 10 years of experience in regulatory affairs within pharma/biotech industry.
  • Experience with both FDA & EMA.
  • Experience on processes such as ODD, fast track designation, PRIME, breakthrough and/or pediatric review priority voucher.
  • Experience in small molecules and orphan drugs is an asset.
  • Flexible, good time management, team-working skills, stress resistant, ability to work proactively and independently.
  • Well-developed communication skills, problem solving skills, creative thinking.
  • Fluent in English. A good command of French and/or Catalan is an asset.
  • Prepared to travel to Spanish site regularly.
Offer:
  • An interesting position within a high-potential clinical stage biotech company.
  • The opportunity to work in a human-sized and multicultural team environment.
  • A variety of interesting contacts with international exposure.
  • An attractive salary package in line with the position responsibilities and your experience.

 

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