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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Consultant / Specialist

Location: 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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