Cardinal Health Regulatory Sciences (CHRS) is a consultancy organization that specializes in regulatory affairs related to drug, device, and biologic product development in the pharmaceutical industry. For 45 years, our industry-trained CMC, nonclinical, clinical, and regulatory consultants have provided expertise and guidance that has enabled pharmaceutical, biotechnology, and medical device companies achieve marketing approval of products. Our mission is in part to design and execute regulatory and product development strategies that reduce the risk of failure and increase financial returns on research investments by pharmaceutical companies worldwide. We provide effective scientific and regulatory consulting services throughout the full product lifecycle. We are growing and looking for talented regulatory affairs experts to help increase our global presence and lead our clients in achieving product development and marketing approval milestones.
The Director, Global Regulatory Affairs will support multiple pharmaceutical companies as a Regulatory Affairs Leader and Subject Matter Expert. Key contributions of this role include developing and implementing regulatory strategies, overseeing all aspects of programs and projects, and lead Health Authority meetings and interactions for our clients, among others.
Leadership, development, and execution of global regulatory strategies across a broad range of drug, device, biologic, and combination product modalities and therapeutic areas
Lead cross-functional internal and external teams, including executive level client teams, and provide strategic insight, recommendations, and business-oriented regulatory opinions, and align teams to each, as applicable
Program and project oversight and management, including budgets, timelines, and resources
Effectively, proactively, and respectfully communicate and engage program and project teams to achieve goals and milestones
Oversee, contribute to, and/or prepare all or part of regulatory submissions including but not limited to INDs, IDEs, IMPDs, CTAs, NDAs, BLAs, 510Ks, PMAs, meeting packages, and those for expedited programs, and ensure they meet regulatory requirements, industry standards, and timelines
Perform and prepare due diligence assessments that may include risk mitigation strategies
Prepare teams for and lead meetings, including face-to-face, with Health Authorities
Serve as the Health Authority point of contact, including as US Agent for ex-US clients
Build, manage, and maintain successful partnerships with clients
Mentor and share knowledge with other CHRS Consultants as needed to help build, establish, and maintain a global regulatory consulting presence
Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance
Contribute to business development activities, including initial client meetings, and provide input on proposals and contracts
Review and approve weekly internal timecards and monthly project invoices
Continually demonstrate Cardinal Health Values and Leadership Essentials
10+ years (with advanced degree) or 15+ years (with Bachelor’s degree) regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry and/or in a regulatory affairs consulting capacity or a combination thereof
Advanced degree (DRSc, PhD, PharmD) preferred but not required; minimum Bachelor’s degree in a life science-related discipline.
Regulatory Affairs Certification preferred, but not required
Experience communicating and interacting directly with major Health Authorities for PIND, IND, EOP2, pre-marketing application, and/or scientific advice meetings in more than 1 major region
Experience with and oversight of marketing application preparation, submission, and approval process in more than 1 major region
Demonstrated experience leading face-to-face meetings with FDA and/or other Health Authorities
Solid knowledge of FDA, EMA, and other global regulations and ICH guidelines
Expert in product development and experience in early to late stage as well as post-approval phases
Demonstrated leadership and program/project management skills, including proven ability to effectively manage cross-functional teams
Regulatory affairs experience in advanced or gene therapies and/or devices a plus but not required
Experience working in a matrixed, global, and multi-site environment
Strong written and verbal, analytical, organizational, and interpersonal skills
Ability to manage multiple ongoing projects, each at various stages of development, with minimal if any supervision
Demonstrated ability to effectively and positively influence stakeholders
Strong attention to detail and right-the-first-time approach
This is a remote work from home position
Telecommuting is allowed.
Internal Number: 20073938
About Cardinal Health
Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. The company provides clinically proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home. Cardinal Health connects patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by nearly 100 years of experience, with approximately 50,000 employees in nearly 60 countries, Cardinal Health ranks #15 on the Fortune 500. For more information, visit cardinalhealth.com, follow @CardinalHealth on Twitter.
Cardinal Health Regulatory Sciences will partner with you to develop the best regulatory pathway for your product, through every stage of its lifecycle. Our regulatory strategies can reduce the risk of failure, and increase your speed to market.
Over the past four decades, our team of 200+ industry-trained regulatory consultants has provided expert guidance to help pharmaceutical, biotech and medic...al device companies get their products to market quickly. Our regulatory consultants average more than 18 years of industry experience, many have worked at the FDA, and more than 65% have advanced degrees. We’ve successfully worked with global regulatory agencies and every review division of the FDA. We’ve provided drug development services for new drugs in all major therapeutic areas, and have experience working across more than 175 countries. Our dedicated