Senior Specialist – Regulatory Science

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🔥 6 minutes ago

🏰 Missouri – Remote

🏰 Missouri – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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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

• Support US labeling activities for Animal Health pharmaceutical and biological products • Coordinate labeling development, review, approval, implementation, and maintenance • Prepare and coordinate regulatory submissions, registrations, annual reports, and postapproval changes • Support regulatory operations, document workflows, submission tracking, and records management • Maintain regulatory documentation, correspondence, trackers, and product information • Support lifecycle management and product stewardship activities • Evaluate product, labeling, manufacturing, and quality changes for potential regulatory impact • Collaborate with Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, and Commercial teams • Support onboarding, training, knowledge transfer, and regulatory-system activities • Ensure assigned deliverables comply with applicable procedures and regulatory requirements • Manage multiple priorities and communicate potential risks or delays promptly • Support other US regulatory consulting activities as business needs evolve

🎯 Requirements

• Bachelor’s degree in a scientific, regulatory, pharmaceutical, or related discipline • Five or more years of regulatory affairs, regulatory operations, labeling, pharmaceutical, biologics, vaccines, or related experience • Experience supporting regulatory submissions, labeling, lifecycle management, or regulatory operations • Experience working with cross-functional teams in a regulated environment • Strong documentation, organization, communication, and problem-solving skills • Ability to manage multiple assignments and work independently • Certification in clinical research or regulatory affairs preferred • Certification in data analytics or scientific data interpretation tools 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