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
Anticipated salary range: $180,000-$200,000
Bonus eligible: Yes
Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
10+ years (with advanced degree preferred) or 15+ years (with Bachelor’s degree in a life sciences discipline preferred) 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;
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
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities.
We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives everyday. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.
With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges – now, and in the future.