Job Ref: 213447536

Date: 2021-03-29 10:56:08

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My client, a Global Pharmaceutical company, is currently searching for an experinced consultant to join their team on an initial contract basis.  Within this role you will work with the Senior Regulatory Team on preparing for Brexit end of transition with a focus on promoted and non-promoted products. 

Responsilities: 

Prepares and submits regulatory documentation with support from RSMO as required
Monitors deadlines for different projects to ensure they are met or escalated to the Head of RA
Responsible for the content of the local labelling documents released to prescribers and patients
Prepares and distributes local labelling documents within stipulated timelines following receipt of relevant approvals from RRR
Prepares and manages local procedures following EMEA Regulatory Affairs strategic plan, assuring timely execution and compliance
Partner with allocated CVT to provide RA expertise and support implements risk management plans and when required co-ordinates cross-functional team to implement/update Risk Management Educational Material
Work with senior Reg Team on preparing for Brexit end of transition
Support up-dating SOP/WI in line with internal Global and EMEA SOPs and external legislation
For further details, please contact Tim Barratt on (phone number removed) or email (url removed)

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