Responsibilities
:
1. Prepare and review regulatory submissions
2. Provide regulatory strategy advice to internal and external clients
3. Provide project specific Global Regulatory Affairs strategy, technical expertise and co-ordination oversight for key client's projects
4. Ensure quality performance for key / managed projects
5. Liaise with the wider business globally to support global projects
6. Extensive contact with people throughout the company, with other regulatory consultants, with clients and with the regulatory authorities
7. Manage Project budgeting / forecasting
8. 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
9. Ensure compliance with relevant organizational and Global Regulatory Affairs Standard Operating Procedures and Working Practice Documents
Experience:
10. Advanced MS Projects user - essential
11. Professional experience within Regulatory
12. Proven people management experience
13. Preferably a bachelor's or higher graduate degree in a science-related field
14. Good knowledge of global / regional / national country requirements and regulatory affairs procedures
15. 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
16. Expert knowledge of ICH and other global regulatory guidelines
17. Excellent English language skills
18. Good organisational and planning skills
19. 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.