Senior Regulatory Affairs Associate

2 weeks ago

Uxbridge, United Kingdom Parexel Full time

When our values align, there's no limit to what we can achieve.Are you passionate about regulatory affairs in the life science industry? Do you thrive in a dynamic team environment and enjoy managing complex projects? Parexel is seeking a talented Senior Regulatory Affairs Associate with biologics or vaccines background to join our growing teamAs a Senior Regulatory Affairs Associate CMC at Parexel, you will be at the forefront of managing and coordinating regulatory submissions across various markets. This role offers an excellent opportunity to develop your expertise in regulatory affairs while working with a diverse range of clients and stakeholders.The role can be home or office based in various European locations.Role ResponsibilitiesManage lifecycle maintenance activities, including renewals, variations, and responses to deficiency lettersCoordinate submission and management work in Veeva VaultCollaborate with various stakeholders, attending regular calls and meetingsMay serve as Project Lead for small-scale projects or Work Stream Lead on larger projectsEnsure project team delivers high-quality work meeting client expectations and timelinesManage project financials and identify new business opportunitiesDeliver consulting services within your area of expertiseMaintain professional interactions with clients and internal teamsSkills and experience required for the roleUniversity degree in a life science disciplineInitial years of regulatory experience in EU and other non-EU markets preferredProficiency in Module 1 and 3 writing with biologics and / or vaccinesStrong organizational and prioritization skillsExcellent communication and teamwork abilitiesAbility to work independently and under guidance of Project Leads or Technical SMEsCommitment to continuous learning and self-developmentFluent in English, written and spoken #J-18808-Ljbffr

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