Manager, Regulatory Affairs

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🔥 1 minute ago

🏈 Alabama, Alaska, +41 more states – Remote

🏈 Alabama – Remote 🐻 Alaska – Remote 🌵 Arizona – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🦌 Connecticut – Remote 🐊 Florida – Remote 🥔 Idaho – Remote 🌽 Illinois – Remote 🌾 Iowa – Remote 🌪️ Kansas – Remote 🐎 Kentucky – Remote ⚜️ Louisiana – Remote 🦞 Maine – Remote 🌾 Nebraska – Remote 🎰 Nevada – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌶️ New Mexico – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🌾 North Dakota – Remote 🏈 Ohio – Remote 🌪️ Oklahoma – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote 🚗 Michigan – Remote ❄️ Minnesota – Remote 🎸 Mississippi – Remote 🏰 Missouri – Remote 🔔 Pennsylvania – Remote ⚓ Rhode Island – Remote 🌴 South Carolina – Remote 🎸 Tennessee – Remote 🤠 Texas – Remote ⛷️ Utah – Remote 🍁 Vermont – Remote ⚔️ Virginia – Remote ☕ Washington – Remote ⛰️ West Virginia – Remote 🧀 Wisconsin – Remote 🦬 Wyoming – Remote 🍑 Georgia – Remote

💵 $125.3k - $178.9k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Cardinal Health

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1971

📦 Logistics

🏭 Manufacturing

🏥 Healthcare

💰 $78M Post-IPO Debt on 2006-08

Logistics • Manufacturing • Healthcare

Cardinal Health is a global healthcare services and products company. It provides a comprehensive range of healthcare services, including medical supply distribution, pharmaceutical distribution, and logistics solutions to various healthcare facilities such as hospitals, community health centers, and ambulatory surgery centers. Additionally, Cardinal Health offers a variety of medical products and pharmaceutical services. The company also focuses on innovative solutions to enhance healthcare delivery, through services like patient support, pharmacy management, and advanced therapy solutions. Cardinal Health is committed to supporting healthcare providers in delivering quality patient care while optimizing operational efficiency.

📋 Description

• Author and/or review and oversee creation of eCTDs for drug submissions to US and outside-US Health Authorities • Support regulatory strategy for drug development • Ensure compliance with conditions of approval of NDAs, ANDAs, MAAs and NDSs • Oversee and perform risk management reviews throughout products' life cycles • Participate in change management internal processes, including engineering and documentation change control and cross-functional project meetings • Identify optimal scientific and technical paths and regulatory filing routes, such as PAS, CBE, or AR in the US • Provide guidance regarding regulatory requirements for manufacturing sites, Cardinal Health facilities, contract manufacturing organizations, and contract laboratories • Manage communication with regulatory agencies, including on-site and remote meetings and regulatory inspections • Represent the company as required • Provide regulatory affairs input into program/project teams • Participate in and represent Regulatory Affairs in cross-functional teams and manufacturing and testing vendor meetings • Manage complex projects with significant and long-term impact • Participate in developing policies and procedures • Recommend new practices, processes, metrics, or models • Independently determine methods for completing new projects • Mentor less experienced colleagues

🎯 Requirements

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical (drug and/or biologic) industry required • Management and authorship of eCTD filings for INDs, NDAs, ANDAs, MAAs, and DMFs • Regulatory strategy development, risk management, and change control participation • Bachelor's degree or equivalent experience in scientific or regulatory field preferred • Advance degree desirable • Documented direct interface with Health Authorities via multiple modes (face-to-face, T-con, and emails) • Excellent knowledge of regulatory and cGMP requirements, including 21 CFR Part 11, Part 210, Part 211, Part 212, Part 314, and other relevant 21 CFR parts and regulatory guidance documents • Prior work experience with European drug applications (NA, MRP, DP, CP) strongly preferred • Knowledge of regulatory requirements as they apply to radiopharmaceuticals preferred • Familiarity with nuclear product development, injectable drug products desirable • Excellent verbal and written communication skills, including authoring technical documents, authoring correspondence with regulators, and developing and delivering effective presentations • Proficient with Microsoft Office software and software for managing drug applications • Diplomacy and negotiation skills, as well as confidence to take unpopular decisions • Ability to work independently and as a member of a team • Occasional travel – 10% or less • Regulatory Affairs Certification preferred

🏖️ Benefits

• Medical, dental and vision coverage • Paid time off plan • Health savings account (HSA) • 401k savings plan • Access to wages before pay day with myFlexPay • Flexible spending accounts (FSAs) • Short- and long-term disability coverage • Work-Life resources • Paid parental leave • Healthy lifestyle programs • Bonus eligible

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