Senior Regulatory Affairs Associate - CMC
Senior Regulatory Affairs Associate - CMC
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Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
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 Regulatory Affairs Associate or Senior Regulatory Affairs Associate to join our growing team!
As 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.
Role Responsibilities:
Manage lifecycle maintenance activities including renewals variations and responses to deficiency letters
Coordinate submission and management work in Veeva Vault
Collaborate with various stakeholders attending regular calls and meetings
May serve as Project Lead for smallscale projects or Work Stream Lead on larger projects
Ensure project team delivers highquality work meeting client expectations and timelines
Manage project financials and identify new business opportunities
Deliver consulting services within your area of expertise
Maintain professional interactions with clients and internal teams
Skills and experience required for the role:
University degree in a life science discipline
Initial years of regulatory experience in EU and other nonEU markets preferred
Proficiency in Module 1 and 3 writing
Strong organizational and prioritization skills
Excellent communication and teamwork abilities
Ability to work independently and under guidance of Project Leads or Technical SMEs
Commitment to continuous learning and selfdevelopment
Fluent in English written and spoken. French language skills would be a plus.
Required Experience:
Senior IC
Employment Type
Full-Time
