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.
- 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.
- Cross functional interactions with Business Unit, Medical and other departments if required. Provision of regulatory advice as appropriate
- Translation of Regulatory documents. Submission and follow-up 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.
- Submission of clinical trials amendments and notifications to competent authorities of the clinical trials under his/her responsibility
- Regulatory Intelligence: Competitors, new regulations or other relevant information
- 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.
- Bachelor's degree (or equivalent) in a scientific discipline.
- Minimum of 2-3 years (in CRO or Pharma) working in Spain regulatory affairs is required
- Experience in initial CTA is essential
- Hands-on experience preparing, reviewing, and submitting regulatory documentations
- Interim/temporary contract maternity leave
- Ticket Restaurant
- Medical Insurance
- Hybrid 60% home-based