Regulatory Affairs Technician
Share
Job Location:
Sant Cugat del Vallès - Spain
Yearly Salary:
EUR 27000 - 30000
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
- Studying scientific and legal documents
- Gathering evaluation organizing managing and collating information in a variety of formats.
- Ensuring compliance with regulations set by the legal authorities as Medicines and Medical devices Regulatory Agency (AEMPS)
- Maintaining familiarity with company product ranges
- Planning undertaking and overseeing product trials and regulatory inspections
- Keeping up to date with changes in regulatory legislation and guidelines
- Analyzing complicated information including clinical trial data
- Offering advice about company policies practices and systems
- Obtaining marketing permission
- Outlining requirements for labelling storage and packaging
- Using a variety of specialist computer applications
- Liasing and negotiating with regulatory authorities
- Providing advice about regulations to manufacturers/scientists
- Writing comprehensible user-friendly clear product information leaflets and labels
- Ensuring that quality standards are met and submissions meet strict deadlines
- Preparing documentation
- Experience in Pharma OTC and pharmaceutical register*
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
