Senior Regulatory Affairs Associate – Marketing Application
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Job Description
Senior Associate managing local regulatory oversight and engagement with Health Authorities for Parexel’s clinical research services. Ensuring compliance and successful product registrations with global impact.
Responsibilities:
- Lead Local Regulatory Responsible (LRR) overseeing LRRs for effective decision making and smooth operations
- Act as the first escalation point for LRR challenges
- Focus on local regulatory requirements and Health Authority national engagements
- Interact with local external stakeholders e.g. Health Authorities, Local industry association(s) and Regional Regulatory Leads
Requirements:
- 5+ years of (local) regulatory knowledge and experience in a regulatory authority facing role
- Leadership experience
- In-depth expertise on local health authority management
- Project management skills; proven experience in managing regulatory submissions, timelines, and cross-functional teams
- Competence to influence stakeholders effectively
- Fluent in local language and English (oral and written)
- Relevant bachelor’s degree or equivalent secondary education e.g. natural sciences (biology, chemistry with pharmacological focus)
- Expert MS Office skills
- Excellent organizational, time management and interpersonal skills in a global environment
Benefits:
- Health Authorities engagement
- Local industry association interaction
- Cross-functional team collaboration
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