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.
Biotechnology, Medical Device, Pharmaceuticals, Quality/Risk Management
Title: Head of Global Regulatory Affairs
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
Internal Number: 9917000
About EPM Scientific
EPM Scientific is a leading specialist recruitment agency for the Life Sciences industry. We were founded in 2012 to give companies and candidates peace of mind that the recruitment process is in experts hands. Today, EPM Scientific provides permanent, contract, and multi-hire recruitment from our global hubs all over the world.
Finding the right people is rarely easy. It takes time, dedication and expertise. We have spent years building relationships with the top scientists, physicians, advisors, engineers and directors in the Life Sciences industry to create an exclusive network of potential candidates. We invest in best-in-class consultant training and innovative recruitment technology to handle the whole recruitment process, from source through to hire, with speed, precision and accuracy.
In the face of disruption, innovation and competition, Life Sciences companies and their leaders must find specialist talent faster than ever before. We want to reimagine recruitment for the better by offering a range of additional services to support our clients and candidates.