319 Regulatory Affairs Specialist

319 Regulatory Affairs Specialist

004-placeholder Tunis, Tunisia - Remote work possible - Life Cycle - Regulatory Affairs & Operations - 003-clock Permanent contract

Specific activities and responsibilities:

Switzerland and/Or Belgium RA market

Degree in relevant life science discipline

3-5 years relevant experience for Switzerland and/Or Belgium RA market

Required technical skills :

Lifecycle maintenance experience

Providing support during external and unannounced audits.

Responding to internal requests for technical and/or regulatory information.

Request payment of fees and subsequent approval (administrative co-ordination)

Assisting with license applications as required.

Preparation and submission of documentation for post-approval applications including, but not limited to, variations Renewals, MAH Transfers/COAs Preparation and submission of Technical/Site Transfer Applications Assisting with the preparation of Marketing Authorisation Applications Monitor and maintain up-to-date knowledge of national and European guidelines/legislation. Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.

Ensuring compliance with the regulations of the assigned Countries within Australia Region

Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc

A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
+ General regulatory administration duties and compliance requirements
+

Management of artwork generation/ labelling/creation/update of product information (at least 3-5 years)Upload of local Product information to national patient/HCP website

319 Regulatory Affairs Specialist

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