Senior Specialist – Regulatory Science

Job not on LinkedIn

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $52k - $81.6k / year

⏰ Full Time

🟠 Senior

🚔 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

• Support US regulatory activities for pharmaceutical and biologic products across multiple programs and clients • Prepare, coordinate, and support regulatory submissions, registrations, annual reports, and post-approval changes • Support labeling development, review, approval, implementation, and maintenance activities • Maintain regulatory documentation, correspondence, submission trackers, and product information • Support regulatory operations, document workflows, submission tracking, and records management • Contribute to lifecycle management and product stewardship activities across the product lifecycle • Evaluate product, labeling, manufacturing, and quality changes for potential regulatory impact • Collaborate with Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, Commercial, and other stakeholders • Support onboarding, training, knowledge transfer, and regulatory systems activities • Ensure deliverables comply with procedures, client expectations, and US regulatory requirements • Manage multiple priorities and communicate risks, issues, or delays in a timely manner • Support broader US regulatory consulting activities as business and client needs evolve

🎯 Requirements

• Experience supporting US regulatory activities for pharmaceutical and/or biologic products • Familiarity with regulatory submissions, labeling, lifecycle management, and regulatory operations • Strong organizational skills with the ability to manage multiple projects and deadlines • Effective communication and stakeholder management skills • Experience working in a consulting, client-facing, or cross-functional environment is a plus • Animal Health regulatory experience is desirable, but not required

🏖️ 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