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Regulatory Affairs Technician

  • Locatie:

    Alcalá de Henares, Spanje

  • Contactpersoon:

    Jorge Vega Perez

  • Contractsoorten:

    Contract

  • Bedrijfssectoren:

    Pharmaceutical

  • E-mail contactpersoon:

    jorge_vegaperez@oxfordcorp.com

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

Responsibilities:

.Compile, write, review and publish registration dossiers for new product registrations by applying solid international regulatory knowledge and CMC expertise.

. Collaborate effectively with internal partners and global clients for the maintenance of marketing authorizations of all out-licensing activities.

. Consolidate authorized dossiers and perform regulatory activities to ensure regulatory compliance.

. Coordinate working groups for the effective response to deficiency comments from international regulatory agencies and author response documents with support from working groups.

. Provide regulatory support and insight to internal and external partners.

. Collaborate with service providers and coordinate activities with internal/external partners to meet regulatory objectives.

. Maintain regulatory database on a daily basis.

. Coach other junior regulatory specialists in the department.

. Participate in product development activities and periodic meetings with upper management

Requirements:

· +3 years experience experience in Regulatory Affairs Pharma departments.

· Academic Degree in Life Science

· Advanced IT level - (MS Office)

· Proactive, good communication, accurate, detail orientated.

We offer you:

A highly professional, dynamic, ambitious working environment.

Initial salary: 35.000 euros gross year +10% variable

40% remote work

Permanent position. The hiring bill be done directly by this company.