Director, Regulatory Affairs CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic leadership in CMC regulatory matters across intricate client programs, aiding in development, submissions, and lifecycle activities.

• Lead significant client projects while acting as a senior advisor in client-facing interactions.

• Ensure adherence to timelines, quality standards, and financial goals.

• Propel regulatory strategy, engage with health authorities, and manage scientific advice initiatives leveraging extensive CMC expertise.

• Foster business growth through the development of proposals, bid defenses, management of client relationships, and the identification of new opportunities.

• Contribute to operational excellence within the Practice Area by mentoring, coaching, and developing team members.

• Provide leadership and oversee resources for the US CMC team.

• Ensure adequate staffing, capability enhancement, and project delivery support.

• Support business expansion and operational efficiency through recruitment, coaching, utilization management, and collaboration with Practice Area leadership.

⛳️ Requirements

• Bachelor's degree in business administration, healthcare management, or a related field, or equivalent experience is required.

• A minimum of 10 years of experience in scientific consulting, healthcare, life sciences, or a related field is required.

• At least 5 years of experience in a management role is required.

• A Master's degree in business administration, healthcare management, or a related field, or equivalent experience is preferred.

• Certification in clinical research or regulatory affairs is preferred.

• Certification in health economics, outcomes research, or methodologies related to real-world evidence is preferred.

🏝️ Benefits

• Medical, dental, and vision care.

• Backup dependent care.

• Adoption assistance.

• Infertility coverage.

• Family building support.

• Behavioral health solutions.

• Paid parental leave.

• Paid caregiver leave.

• Training programs.

• Professional development resources.

• Mentorship programs.

• Employee resource groups.

• Volunteer activities.

• Reasonable accommodations during the employment process.