Achieva Group Ltd

Regulatory Affairs Manager - Part time 30 hours p/w

7 days left

Location
London
Salary
£40 - £65 per hour
Posted
15 Apr 2021
Closes
15 May 2021
Ref
BH-25570
Contact
Tim Barratt
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
An excellent opportunity has arisen for a contractor to join my client on a 12 month contract basis, working 4 days per week.  This is a fully remote based role and the ideal consultant will have a strong background in EU post approval regulatory affairs.
 
Responsibilities
  • Be a part of the Project management team overseeing successful initiation, execution and completion of Regulatory programs for the clients Global clients.
  • Responsible for managing project deliverables in line with the project plan
  • Responsible for compilation, tracking and reporting of the project reports on timely basis.
  • May have oversight of initiation, execution and completion of projects for the clients clients; and ensuring delivery is within time and budget; if not, take corrective action
  • Act as a subject matter expert and help the team members with day-to-day trouble shooting activities.
  • Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management.
  • May be a main point of contact for clients, maintaining interactions on a regular basis to understand the client’s requirement for a particular project and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints.
 Candidate Profile:

Educational qualifications (UK):
  • A minimum of a graduate degree in Life Sciences
  • Candidates with experience in Regulatory affairs with exposure to regulatory filings as a part of a pharmaceutical company is preferred
  • Good knowledge on regulatory requirements and/or guidelines and exposure to relevant document management systems and publishing tools are preferred.
Key skill requirement
  • Experience and knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc.
  • Experience and knowledge of EU related procedures (MRP, DCP, CP) for post-approval maintenance submissions
  • Excellent written communication skills
  • Working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel
  • Core competencies for this role include: 
    • Effective workload management as an individual and as team manager
    • Analytical capabilities
    • Professional service mentality – willing to go beyond the call of duty to satisfy their clients
    • Commitment to highest quality outputs, including obsessive attention to detail
    • Enthusiasm and pro-activity
    • Team collaborators, ability to be successful working in teams
 
 
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk

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