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Regulatory Affairs Project Manager

Job title: Regulatory Affairs Project Manager
Contract Type: Permanent
Location: Cheshire, England
Industry:
Salary: £80000 per annum
Reference: BH-123672
Contact Name: Lisa Kitt
Phone Number: 07539 074151
Job Published: 11 days ago

Job Description

Regulatory Affairs Manager

We are working on an exciting and new assignment with a large and growing Biotechnology company recently establised in the UK , recruiting for an experienced Regulatory Affairs Manager to project manage regulatory submissions to EMA and interactions with agencies.   This is a great opportunity to join a growing team and an intgral part of the UK growth strategy 

Key responsibilities include 

  • Project manages the full range of regulatory submissions to EMA and interactions with EU agencies, ensuring delivery to time, cost and quality
  • Maintains project planning and coordinates activities with colleagues to ensure submission requirements and timing are in alignment with overall project timelines and goals
  • Oversees publishing activities of all electronic and paper regulatory submissions
  • Supports special submissions including meeting requests, orphan drug designation requests and pediatric study plan requests
  • Manages external providers who provide regulatory services, to ensure they are equipped to deliver to time, cost and quality
  • Provides input to EU regulatory strategy for compounds in development, combining knowledge of regulatory issues with scientific and business factors
  • Works with archivist to track and maintain regulatory document repository
  • Provides guidance to employees and consultants on EMA regulatory requirements
  • Reviews study data files for regulatory compliance
  • Writes and/or updates regulatory submission SOPs and other guidelines, communicating updates and information as appropriate
  • Examines and researches laws, regulations and guidelines governing the development of drugs
  • Represents RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate
  • Serves an EMA correspondent when needed
  • Supports the preparation of documents including protocols, IBs, MAA documents etc as needed
 
Required Education & Qualifications
  • Bachelor’s degree in a scientific discipline
  • 5+ years of experience in a regulatory affairs role, including EMA experience
  • Thorough working knowledge of regulatory agency requirements (EMA, FDA) and ICH, with successful experience of global clinical trial and marketing applications
  • Ability to liaise with regulatory agencies
  • Drug development knowledge, with oncology-specific experience highly desired
  • Knowledge of GCP, GMP and GLP
  • Ability to manage projects and to work both independently and within a team environment
  • Strong writing and communication skills
 


 
If you believe you possess the necessary criteria to take the next step in your career as a Regulatory Manager  with a leading clinical organization, please apply or send your CV direct to lisa.k.a2tui34en@nesgt.aptrack.co.uk