Senior Regulatory Project Manager
Location: Reading and Remote
Salary: Circa £65,000 - £75,000, DOE plus comprehensive and competitive benefits including 18% target bonus, Private Health Care, and competitive pension
Are you an experienced Regulatory Affairs professional with a proven track record leading and influencing local and regional team? Do you have experience working across the EU region managing key projects having oversight for strategic assets from Clinical Trial Application (CTA) through to Marketing Authorisation Applications (MAA) and Life Cycle Management? If you are looking for a role within a leading Pharmaceutical company where you can combine your Project Management experience with extensive Regulatory Affairs oversight this would be a fantastic opportunity to showcase your talents in a globally visible role.
As part of the EU team, you will partner with 2 other Senior Regulatory Project Managers in a dual role that has 50% involvement within the EU Policy group, and 50% responsibility within the UK Oncology team. You will be responsible for managing all elements of Regulatory Authority interactions from Clinical Trial Applications (CTA) through to and including Marketing Authorisation Applications (MAA), as well as having regional responsibilities for providing regulatory strategic leadership for the Oncology portfolio. In addition to this, as part of the Regulatory Policy and Intelligence Network, you will hold significant influence and give direction in a large regional matrix team, with key project management responsibilities.
Producing high-quality marketing authorisation, variation and clinical trial applications in line with UK/EU requirements.
Delivering innovative regulatory strategies and promoting awareness of regulatory requirements.
Managing regulatory challenges and pro-actively highlighting impact of external changes
Contributing to UK / EU Regulatory Policy by assessing the external regulatory environment and communicating it to the internal organisation.
Participating in external EU/UK committees/working groups.
Supporting UK Regulatory team development by being an ambassador for the UK team.
QUALIFICATIONS AND EXPERIENCE
To be considered for this role our client is looking for candidates that are able to demonstrate the following skills, and experience;
Bachelors or advanced degree in appropriate scientific discipline
Experienced UK / EU regulatory professional having managed major submissions and approvals via the Centralised Procedure (CP), preferably in oncology
Sound knowledge of clinical trial requirements, particularly in major EU countries
Ability to think strategically, sound commercial awareness and good knowledge of medicines development within EU
Excellent communication skills including proven ability to influence by persuasion and negotiation. Ability to communicate complex information in an engaging manner, both verbally and in written form. Presentation skills are a key communication vehicle for networking within and outside the organisation.
To apply or request further details, please contact David Jolley at email@example.com or call +44 (0)7738 586 627, or +44(0) 2393 877 358
Compass Associates Ltd. trading as Compass Life Sciences are acting as a Recruitment Consultancy for this permanent vacancy; we offer £200 worth of John Lewis Vouchers for each successful recommendation.