Description
We are looking for a
Global Regulatory Affairs Associate (m/f)
Reference: -en
Start: ASAP
Duration: 24 MM
Place: in the Basel region
Branch: Pharmazeutische Industrie
Your tasks:
- Perform gap analyses of registration dossiers for assigned products
- Provide regulatory support for key global organizational and transformational projects
- Prepare, coordinate and submit variation files and responses to health authority requests for assigned transfer projects (eCTD submission)
- Prepare and coordinate updates of regulatory databases (e.g. milestone tracking of new submissions, renewals, variations etc.)
- Liaise with all relevant internal departments and partner companies to ensure availability of required documentation
- Support of regulatory managers in all administrative aspects, e.g. organization of all country specific certificates including legalization (CPPs, CoAs, MLs, GMPs etc.) and correspondence
- Support of preparation, organization and management of shipment of dossiers to health authorities or partner and distributors
Your qualifications
- Bachelor, PTA, CTA, MTA or similar education
- Experience in a pharmaceutical industry, especially in the regulatory affairs area
- Good computer skills (MS Office applications esp. Word, Excel and PowerPoint)
- Experience in eCTD and Document Management systems (e.g. DocuBridge) and regulatory databases is a must
- Excellent planning and organisational skills
- Team player mentality and good communication skills
- Fluent in German and English (written and oral); any further language skills are of advantage
Skills:
- Regulatory affairs assistant