Regulatory Affairs Consultant – Clinical Regulatory Affairs
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Job Description
Regulatory Affairs Consultant guiding clinical studies through regulatory processes for Parexel. Collaborating with cross-functional teams to ensure compliant and efficient trial execution.
Responsibilities:
- Serve as Regulatory Affairs Lead for 5+ clinical studies within a dedicated client team
- Provide strategic regulatory guidance to cross-functional study teams navigating complex and evolving global requirements
- Assess regulatory impact of protocol amendments, informed consent form (ICF) updates, and other study changes
- Advise teams on regulatory pathways, processes, and solutions for emerging trial issues
- Plan, coordinate, and author health authority meeting requests and scientific advice packages, as required
- Manage regulatory communication strategy for assigned studies
- Participate in regular study team meetings to track trial progress and proactively surface regulatory considerations
- Maintain accurate, current regulatory tracking systems in accordance with Parexel and client standards
Requirements:
- At least 5 years of regulatory affairs experience to include previous clinical regulatory affairs experience
- A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree strongly preferred
- Knowledge of FDA Regulations and previous experience with FDA meeting requests and other packages
- Experience with other global Health Authorities and applicable regulations are strongly preferred
- Project management / leadership experience
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Client-focused approach to work (Quality)
- Results orientation
- Teamwork and collaboration skills
- Consulting skills
- Critical thinking and problem-solving skills
- Proficiency in local language and extensive working knowledge of the English language.
Benefits:
- Regulatory Strategy & Compliance
- Health Authority Engagement
- Stakeholder Partnership & Communication
- Documentation & Project Management
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