Regulatory Affairs Associate

Recruiter
Magpie Recruitment
Location
Feltham
Salary
20000.00 GBP Annual
Posted
02 Aug 2017
Closes
30 Aug 2017
Function
Consultant
Contract Type
Permanent
Hours
Full Time

Background Experience/Qualifications

  • Degree in an associated science subject
  • Knowledge of regulatory regulations (optional)
  • Ability to prioritise and organise workload
  • Strong team-working skills and communication skills (verbally and written)
  • Attention to detail and reliable

Key Tasks:

  • Assist the Regulatory Affairs Manager.
  • Support administrative requirements of the department.
  • Assist in the implementation of the regulatory software system.
  • Maintenance of the departmental regulatory database.
  • Assisting the Quality Assurance department in maintaining the QMS and various tasks and procedures (OOS, change controls, deviations, CAPAs etc).
  • Publishing and tracking of UK/EU regulatory submissions (Type 1A, Type 1B and Type II).
  • Archiving of national regulatory submissions and approvals, both electronic and hard copy.
  • Support and align with other departments/functions on needs re periodical requests. (e.g., tender support).
  • Provide input to local cross functional teams on status of planned, pending and approved regulatory submissions.
  • To comply with Health and Safety Regulations.
  • To maintain the confidentiality of all information relating to the business activities of the Company (and sister companies).
  • To perform other duties as directed by the Company.
  • On the job training