Snr Specialist Regulatory Affairs
- Permanent
- Consultant / Specialist
- Germany
We are recruiting a Senior Specialist Regulatory Affairs Lead for Germany to ensure regulatory compliance of drugs commercialised in Germany with the pharmaceutical and legal regulations in accordance with the applicable regulations.
Job Responsibilities
- Local implementation of EU-registered medicinal products
- Labelling changes, i.e. translation checking and implementation into national texts
- Updates of educational materials
- Updates of packaging materials
- Deputy for local implementation activities
- Oversight and control of local implementation for all Alexion products in Germany
- Compliance with additional risk minimisation measures
- Deputy for additional risk minimisation measure activities
- Deputy for regulatory review of promotional and non-promotional materials if necessary
- Management of all regulatory SOPs in the quality management system (QMS) in cooperation with QA, such as updates/creation of new SOPs and training
- Compliance with the quality management system (QMS) and necessary actions, such as Deviations and Corrective Action Preventative Actions (CAPAs)
- Invoice and PO management
- Material management in logistics service centre HyBizz/C4: coordination of printed regulatory texts (educational materials, SmPC)
- Submission of product changes to IFA; submission of updated SmPCs and educational materials to ABDATA
Skills and Requirements
- At least 3 years' experience in the pharma/biotech industry including experience in a similar position.
- Good knowledge of regulatory framework in Germany and EU
- Experience in interactions with authorities
- Experience in Risk Management Plan implementation activities
- Experience in QMS/SOP management
- Social skills and active collaboration with cross-functional colleagues (e.g. CMC, quality assurance, drug safety, marketing)
- Very good written and spoken German and English
To Apply
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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