The Director of Global Regulatory Affairs will lead a dispersed team of full-service strategic product development and global regulatory affairs consulting teams that enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. The Director will have experience interacting with foreign and domestic regulatory bodies, passion for leading people, a demonstrated record growing market share and relevant academic credentials and scientific knowledge.
The business has a diverse portfolio of projects spanning large, publically traded organizations to venture/private equity backed drug and medical device entities across a range of therapeutic categories and formulation varieties.Within the business,
Regulatory Sciences is a division of Specialty Solutions within Cardinal Health’s Pharmaceutical Segment.
Lead regulatory strategy, oversight and guidance and effectively leading cross functional teams
Interact effectively with the FDA and other foreign regulatory bodies.
Provide leadership for a diverse and complex organization
Communicate effectively with external agencies and build upon Cardinal’s reputation for integrity and ethical behavior
Direct and manage the preparation, submission and maintenance of INDs, NDAs and other regulatory applications
Assist in clinical studies required for regulatory approvals, including clinical study design, data analysis, and data reduction
Proactively inform leadership team of regulatory status of products and significant regulatory issues
Provide counsel, training and interpretation of FDA and other regulatory issues to company personnel and act as a liaison between the company and regulatory authorities
Author, review and critique documents included in regulatory applications for domestic and international authorities
Obtain and disseminate information regarding current activities, trends and changes in the regulatory environment
Host FDA/third party regulatory audits and ensure follow up on findings/observations issued including CAPAs, as needed
Serve as a principal spokesperson on significant matters related to the position’s oversight
Appropriately manage organizational and project budgets
Strategic mindset and approach coupled with a hands-on operating style
Participate, with executive leadership, in the development and implementation of strategic business plans, decisions and recommendations
Remain assessable and coach employees when needed; maintain high levels of work and employee accountability
Maintain and fully utilize broad external network to enhance business opportunities and grow market share; strong negotiation skills
Strong focus on broad spectrum of Cardinal Health sales opportunities including new business directions
Drive a creative and focused strategy, leading to the effective management and growth of Cardinal Health’s Regulatory Sciences business; encourage informed risk-taking and act as a catalyst for innovation
Identify emerging technologies and instrumentation and make appropriate recommendations for business application
Demonstrated ability breaking down silos and rebuilding team across an organization
Ability to effectively manage highly experienced consultants while nurturing and mentoring those less experienced
15 years of experience in the pharmaceutical industry; 10 years of relevant experience within Regulatory Affairs
BS/BA in a relevant field of study required; MS or PharmD/PhD preferred
Proficient in the delivery and conduct of all Regulatory Affairs activities including, but not limited to: submissions, publishing, review and oversight
Thorough understanding of regulations of ICH, FDA and EMA.
Knowledge of GLP, GMP and GCP regulations
Ability to work well under pressure and adhere to deadlines
Proven ability to manage and grow productive teams
Excellent written and verbal communication skills
Ability to travel up to 40 percent
High attention to detail
Clear, concise communicator
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or protected veteran status.
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