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.
Job Description: CMC Regulatory Affairs Senior Manager, CMC Consultant, 100% Remote The Company - Syner-G Pharma Consulting, LLC: A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls (CMC) for biopharmaceutical companies (small molecule and biologic products) Adept in developing risk-based CMC strategies following cGMP for 21st Century initiatives and Quality by Design (QbD) principles Distinguish ourselves by our passion for creativity and innovation Offer flexible work environment allows for on-site, off-site, and virtual-office scenarios Clients include national and m
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