Regulatory Project Manager

Regulatory Project Manager

12 month contract
American CRO
UK based role - the successful applicant must be prepared to travel to office in Maidenhead twice per week
£50 per hour inside IR35

Key responsibilities

• Manage, plan and execute Regulatory projects, including planning resources, budget, strategic input and review, risk analysis and implementation strategy
• Tracking closely to anticipate and address project issues and work closely with all internal stakeholders across the Regulatory team, together with external stakeholders such as the clients, MHRA, other Health Authorities
• Responsible for proactively mapping the business needs versus planned changes to regulatory files and legislation, ensuring timely, competitive and strategically enhancing submissions and approvals for the MHRA and other regulatory bodies

Qualifications

• A Science graduate with a proven successful track record within the pharmaceutical industry relating to managing projects within the regulatory environment. Essentially demonstrating full knowledge of regulatory legislation and processes (national and EU)

• Previous experience of compiling, submitting, and gaining approval for Marketing Authorisation Applications (MAA) is essential

• The successful candidate for this opportunity will be a highly organised, proactive, extremely adaptable individual who can work independently but is also an enthusiastic team player who can contribute to effective team performance with excellent communication and influencing skills and the ability to build relationships at all levels

• The ability to lead complex operational and strategic projects is essential, with clear evidence of successful cross functional working and problem solving. A high level of concern for quality and detail is necessary along with good IT skills