Manager, Regulatory Project Management
A vacancy has arisen for a Manager, Regulatory Project Management with an internationally renowned pharmaceutical company, based in their UK office. This organisation is known for its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. This is an exciting opportunity to work with a leading pharmaceutical organisation and support their innovative impact on the healthcare field. Please note that this will be a contract position, lasting 12 months, and will focus on project management over regulatory affairs.
- Working closely with cross-functional submissions teams including Regulatory Affairs, CMC Regulatory Affairs, Publishing, and In-country Affiliates to ensure that submissions are prepared to agreed timelines.
- Leading meetings with the cross-functional submission teams to plan, coordinate, prioritize, and track submissions for the region and/or specific countries.
- Preparing and maintaining submission plans using MS Project.
- Preparing materials to support the team in developing submission strategies and prioritising activities, such as Visio process maps.
- Preparing and maintaining meeting outputs, action logs etc.
- Developing risk strategies and maintaining risk logs.
- Potentially working on special projects, process improvement projects and supporting EU RA teams as necessary.
Skills and Requirements:
- A degree in a scientific field is preferred.
- Minimum of 5 years Project Management experience.
- Stakeholder management experience.
- Demonstrated ability to discuss and negotiate critical and complex strategic issues with colleagues at all levels.
- Able to articulate complex regulatory project management risks and issues with colleagues at all levels.
- Must be capable of leading a small team without direct line management responsibility.
- Experience of collaborating using Zoom, Skype for Business, or similar, with colleagues in other countries, particularly where English is not their first language.
- An understanding of pharmaceutical regulatory processes, manufacturing, change control and global distribution systems is an advantage.
- Experience within a regulated industry is preferred.
- Project management qualification such as PRINCE2 is desirable.
- Risk management experience.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Luke Saner at +443300524502 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.