Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

Senior Regulatory Affairs Manager

Posted Mar 18, 2021
Job ID: JJJP00006106
Location
High Wycombe
Duration
6 months
(Apr 12, 2021 - Oct 11, 2021)
Hours/week
37 hrs/week
Payrate range
60 - 70 £/hr
  • Senior Regulatory Affairs Manager
  • Remote working
  • 6-month contract with possibility of extension


You'll be providing Regulatory support for promoted and non-promoted products.


Responsibilities:


  • 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


Other key activities:


  • 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

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