(Senior) Regulatory Affairs Consultant managing regulatory submissions for various clients at Parexel. Collaborating with stakeholders and ensuring high-quality work for client satisfaction.
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 small-scale projects or Work Stream Lead on larger projects
Ensure project team delivers high-quality 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
Requirements
University degree in a life science discipline
Solid regulatory experience in EU, other non-EU 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 self-development
Fluent in English, written and spoken.
Benefits
Flexible working arrangements
Opportunities for professional development
Job title
Senior Regulatory Affairs Consultant, CMC, Small Molecules
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