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.

Accountabilities

• 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