The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Working with a key pharmaceutical client on a BRAND-NEW Head of Regulatory Affairs position. Reporting to the CEO, The Head of Regulatory Affairs will lead the entire Regulatory function in the development and implementation of regulatory strategies and operations ensuring timely delivery of regulatory submissions. The Head of Regulatory Affairs is responsible to compile, prepare, and review the various documents for content completeness and compliance with all the regulatory requirements.
Lead the Regulatory preparations and submissions of documents to support investigations and marketing registrations
Submissions include IND/NDA/CTA/eCTD/CTD/ANDA, Amendments, Annual Reports
Manages vendors as needed to support regulatory submission goals.
Oversee and provide Regulatory strategy and operations, activities in support to product and portfolio assignments, which includes general regulatory strategies, regulatory requirements in domestic and international markets, and regulatory submission requirements.
Manage internal regulatory procedures to ensure compliance
B.S. in a scientific discipline required
Must have 15+ years pharmaceutical industry
10+ years of experience directly in regulatory affairs
Global and US experience required
Extensive experience working and liaison with FDA and other health Authority officials to ensure timely regulatory approvals.
Knowledge of Clinical, Nonclinical and CMC regulatory related issues
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