Company: Pharmalink Consulting
Closing Date: 25 Dec 16
Salary (£): Competitive
Genpact Pharmlink is a highly specialised Regulatory Affairs Consultancy with a successful history. The success of Genpact Pharmalink depends on its people. Capitalizing on what is unique about individuals and drawing on their different perspectives and experiences will add value to the way we do business.
Role based – Maidenhead, Berkshire
Start date - January 2017
Senior Regulatory Executive / Lead Consultant
Genpact Pharmalink is currently recruiting for more talent for our UK team. We have some exciting opportunities based in our Maidenhead project management hub.
The ideal candidate will be highly motivated and bring both the practical experience of National and European regulatory affairs and the ability to evolve to stay ahead of new guidelines and legislation. The successful candidate will instantly become an integral part of our expert team, hitting the ground running with client project work and Lean Six Sigma continuous improvement methodologies.
This is an exceptionally demanding role which would require you to represent our company to external client stakeholders, joining a busy team of ambitious and industrious regulatory professionals. You will also play a crucial role in the planning and strategy for potential new client projects. You will be an enduring point of contact with our clients, and will need to be available to junior members of the team to offer support and guidance. This role requires excellent communication, organisation and problem-solving skills.
Our ideal employee would have:
• Around 4 years’ experience working with National and European pharmaceutical products
• Previous practical experience of conformance projects, including difference analyses and remediation strategies.
• Good background in post-approval maintenance work including variations, renewals, line extensions.
• Comprehensive understanding of the content of all Module 3 CTD sections
• Excellent written and spoken English
• An aptitude for working to deadlines, objectives and goals. The ability to manage conflicting priorities.
• Good influencing skills and networking ability
• Both the capability to work independently and the flexibility to work in a team
• Be able to use Microsoft Word and Excel to a high standard
Vanwall Business Park
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