Regulatory Affairs Project Manager

Are you an experienced Regulatory Affairs Project Manager with exposure covering both EMEA and APAC regions? Do you have advanced skills in utilising MS Projects across previous roles? If so, this could be the perfect opportunity for you!

We are recruiting for a Regulatory Affairs Project Manager to join a globally leading CRO that provides comprehensive drug development and laboratory services to accelerate the delivery of new therapies to market.

The successful candidate will need to demonstrate strong skills with MS Projects as part of the interview process.

This role is offered on a contract basis initially for 12 months, you can be based remotely from anywhere in Europe.

Responsibilities:

Prepare and review regulatory submissions
Provide regulatory strategy advice to internal and external clients
Provide project specific Global Regulatory Affairs strategy, technical expertise and co-ordination oversight for key client's projects
Ensure quality performance for key / managed projects
Liaise with the wider business globally to support global projects
Extensive contact with people throughout the company, with other regulatory consultants, with clients and with the regulatory authorities
Manage Project budgeting / forecasting
Assist in identifying and recognizing out of scope activities in a contract in a timely manner and liaise with Contracts & Proposals Team to follow through on all aspects of contract modification
Ensure compliance with relevant organizational and Global Regulatory Affairs Standard Operating Procedures and Working Practice DocumentsExperience:

Advanced MS Projects user - essential
Professional experience within Regulatory
Proven people management experience
Preferably a bachelor's or higher graduate degree in a science-related field
Good knowledge of global / regional / national country requirements and regulatory affairs procedures
Proven experience in at least one of the following areas; Authoring Chemistry Manufacturing & Control documents for post-approval regulatory submissions, Development of product information for post-approval regulatory submissions, Working within Regulatory Information Management systems and submission publishing for electronic submissions to regulatory agencies or Regulatory submission experience in marketing authorisation applications
Expert knowledge of ICH and other global regulatory guidelines
Excellent English language skills
Good organisational and planning skills
Ability to motivate and integrate teams and teach / mentor team members
Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission. Where the role is marked as Outside IR35 in the advertisement this is subject to receipt of a final Status Determination Statement from the end Client and may be subject to change