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Regulatory Affairs Specialist

  • Lieu:

    Espagne

  • Contact:

    Nina Salmito

  • Type de poste:

    Contract

  • Téléphone de contact:

    0034 93 522 23 38

  • Secteurs d’activité:

    Biotechnology

  • Contact E-mail:

    nina_salmito@oxfordcorp.com

We are looking for a Regulatory Affairs Technician to join the team of our client an important company of the pharmaceutical industry.

Functions:

Collaborate with cross-functional teams to ensure that various regulatory pathways are reviewed and challenged early in the development process.

Develop and present an assessment of the business risks associated with the preferred regulatory strategies, along with the mitigation plans, to the project team and management in order to keep commercialization progress on track.

Identify and supervise outsourced regulatory activities to CROs or consultants.

Provide appropriate interface with global regulatory agencies in meetings. Provide guidance, interpretation, and opinions on complex regulatory matters (particularly related to submission pathways), outlining the different outcomes.

Develop and maintain outstanding relationships with all regulatory and compliance agencies.

Lead regulatory due diligence assessments and recommendations for out licensing, acquisitions and/or partnering.

Regularly present regulatory strategies, associated risks, and potential solutions to the Management Team and Board of Directors.

Define and track the quality assurance plan in Oncomatryx including the supervision of required SoPs.

Requirements:

  • PhD degree in a technical discipline (biology, chemistry or engineering preferred).
  • 5+ years experience in a Regulatory Affairs team.
  • Experience with FDA (IND process) and EMA/national competent authorities (IMPD/CTA).
  • Very good writing/reviewing skills of regulatory documents
  • Proficient in both Spanish and English
  • Willingness to work in small biotechnology company
  • Not concerned with working from home with sporadic travelling in Spain.

We offer you:

  • Permanent position. The hiring bill be done directly by this company.
  • A highly professional, dynamic, ambitious working environment.
  • Salary: Negotiable (according to experience and skills)
  • 100% remote work
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