Sr Regulatory Affairs - Madrid, España - Oxford Global Resources

Oxford Global Resources

Empresa verificada

Madrid, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

Sr Regulatory Affairs

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Location:

Madrid, Spain

Contact:

Susagna Sastre Magem

Job type:

Temp to Perm

Industry:

Pharmaceutical, Life Sciences, Biotechnology

Oxford Global Resources ETT is looking to hire a
Regulatory Affairs Specialist (maternity leave) who will start in August 2023.

As a Regulatory Affairs Technician you will support a top leading research-based bio pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.

Responsibilities

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Review promotional and non-promotional materials in accordance with the company internal promotional guidelines, national regulations and Codes of Practice. Provision of guidance and assistance to Marketing during preparation of promotional material.

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Cross functional interactions with Business Unit, Medical and other departments if required. Provision of regulatory advice as appropriate
Translation of Regulatory documents. Submission and followup of regulatory submissions to national authority as well as the amendments to product information as required by acting as a Liaison with Int RA for these activities.

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Submission of clinical trials amendments and notifications to competent authorities of the clinical trials under his/her responsibility

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Regulatory Intelligence:
Competitors, new regulations or other relevant information

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Quality topics: Knowledge of applicable regulations. Preparation and update of Quality SOPs, management of complaints and other quality topics.
Creation and update of SOPs and associated process documentation as required.

Education

Bachelor's degree (or equivalent) in a scientific discipline.
Minimum of 23 years (in CRO or Pharma) working in Spain regulatory affairs is required
Experience in initial CTA is essential
Handson experience preparing, reviewing, and submitting regulatory documentations

Benefits