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.
Biologics, European Union Regulatory Affairs, Quality/Risk Management, US Regulatory Affairs
You are recognised as a leader with extensive experience in CMC biologics, both originators and biosimilars. You may have even engaged in projects in the cell & gene therapy space.
You have worked on product development and regulatory strategy and understand this critical intersection. You have probably also had first-hand experience in cGMP manufacturing, process development, process characterisation and validation, protein analytics and viral safety.
You have led interactions with regulatory agencies (FDA, EMA and other national agencies), prepared and managed meetings, authored briefing documents, and understand the nuances of agency minutes and feedback. Your agency submission experiences include authoring Modules 3 and/or 2.3 for IND, IMPD, BLA and MAA.
Maybe you are looking for a new challenge or looking to return home to UK, Europe or Australia.
ERA Consulting is a global strategic product development and regulatory consultancy and we are looking for you. Our clients are supported with regulatory and technical expertise for novel projects in various stages development. ERA’s business is growing, and growing fast and we are looking to add talent, like you, to our team in either London, Walsrode, Brisbane or Melbourne.
You have strong scientific credentials, qualified to PhD or equivalent. You enjoy working in a stimulating team environment and thrive where you can mentor young, bright upcoming professionals and leave your positive mark on their career development.
If this is you and you believe you can add value to ERA’s clients then please reach out to Andrew Moore (email@example.com) and send your CV. We look forward to hearing from you.
Large molecule CMC Regulatory experience
Led agency interactions
Authored regulatory documentation, including Modules 3 and / or 2.3
Telecommuting is allowed.
Internal Number: RAPs001
About ERA Consulting Group
The ERA Consulting Group is a strategic product development and regulatory consultancy headquartered in Walsrode – Germany, with offices in London – UK, Brisbane and Melbourne – Australia and Washington DC – USA. ERA provides expert advice to the biopharmaceutical industry on process/product development and strategic regulatory affairs. ERA has a proven track record of success, and has worked on more than 500+ medicinal products in its 27-year history and this places ERA in an unrivaled position as consultants in this demanding and highly specialised arena. The ERA team specialises in biological medicinal products, including monoclonal antibodies, biosimilars, vaccines and advanced therapy medicinal products (cell and gene therapy, etc.). ERA’s clients range from small biotechnology start-up companies to the largest pharmaceutical corporations.