Director, Regulatory Affairs CMC

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🕒 Yesterday

🇺🇸 United States – Remote

💵 $119.1k - $186.6k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 0%

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Cencora

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• Provide strategic CMC regulatory leadership across complex client programs, supporting development, submissions, and lifecycle activities • Lead major client projects and serve as a senior client-facing advisor • Ensure delivery against timelines, quality, and financial objectives • Drive regulatory strategy, health authority interactions, and scientific advice activities using extensive CMC expertise • Support business growth through proposal development, bid defenses, client relationship management, and identification of new opportunities • Contribute to Practice Area operational excellence, mentoring, coaching, and development of team members • Provide leadership and resource oversight for the US CMC team • Ensure appropriate staffing, capability development, and delivery support across projects • Support business growth and operational performance 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 required • 10+ years of experience in scientific consulting, healthcare, life sciences, or a related field required • 5+ years of experience in a management capacity required • Master's degree in business administration, healthcare management, or a related field, or equivalent experience preferred • Certification in clinical research or regulatory affairs preferred • Certification in health economics, outcomes research, or real-world evidence methodologies 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

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