Regulatory Affairs Specialist - 319
004-placeholder India, Morocco, Tunis, Tunisia - Onsite and offsite both - Life Cycle - Regulatory Affairs & Operations - 003-clock Permanent contract
Required Technical Skills :
Lifecycle maintenance experience
Providing support during external and unannounced audits.
Responding to internal requests for technical and/or regulatory information.
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, European and International 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 the European and International Regions
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)
Additional Experience and/or Skills :
EU (NP, CP, DCP, MRP, Worksharing) experience
Local IT, BE or CH experience
Previous experience of people management/coordination would be an advantage
Experience of promotional/non-promotional activities would be an advantage (at least 3-5 years)
Good IT skills/knowledge
Good organizational skills Good communication skills Pro-active attitude and able to work on own initiative as well as part of a team
Ability to prioritize different workloads/multi-task
Personal responsibility for ensuring a high standard of work
Hands-on experience of product launches withinEuropean and International regions
Regulatory Affairs Specialist - 319
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