Regulatory Affairs Consultant - Remote

Overview

The Regulatory Affairs Consultant at Parexel plays a crucial role in developing and overseeing CMC strategies for regulatory submissions, ensuring compliance with health authority guidelines, and leading interactions with regulatory agencies.

In Short

• Provide strategic direction for CMC aspects of products.
• Develop strategies for complex regulatory submissions.
• Lead regulatory discussions with Health Authorities.
• Oversee regulatory assessments of manufacturing changes.
• Manage project teams and governance committees.
• Facilitate communication between internal teams and regulatory authorities.
• Stay updated on evolving CMC regulations and guidelines.
• Mentor team members in regulatory practices.
• Drive innovative CMC regulatory strategies.
• Build relationships with key regulatory stakeholders.

Requirements

• Visionary leadership skills.
• Strong strategic thinking and problem-solving abilities.
• Proven experience in regulatory affairs.
• Excellent interpersonal and communication skills.
• Detail-oriented with a focus on quality.
• Ability to manage competing priorities effectively.
• Proactive and self-motivated.
• Adaptable to changing regulatory landscapes.
• Experience in project management.
• Ability to work in a fast-paced environment.

Benefits

• Opportunity to contribute to global health improvements.
• Work with a leading CRO with a global presence.
• Collaborative and supportive work environment.
• Professional development and mentorship opportunities.
• Access to innovative regulatory strategies and practices.