Director, Global Regulatory Affairs

Cardinal Health - USA - 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 Qualifications 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... - Permanent - Full-time

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