Manager/Director, Technical Regulatory managing regulatory submissions for pharmaceutical products. Ensuring compliance with local and global standards in order to support timely approvals.
About the role
- (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
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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