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.
As a growing clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease located in the Greater Boston Area, I am working with my client on an Associate Director, Global Regulatory Strategy position. The company is looking for a highly motivated, Director level individual who wants to join a dynamic and fast-paced organization, by helping to empower and help lead the Global Regulatory Affairs Team. If you are looking for a new opportunity that will give you an amazing chance to start with a growing company that loves to promote from within, now is your chance!
In this role you will be responsible for:
Define, develop, and lead all global Regulatory strategies
Lead the Regulatory department, while working cross-functionally amongst all other teams regional counterparts
Act as the direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports of junior staff as needed.
Provide leadership and development for direct reports and for those that serve as global regulatory leads responsible for the design and execution of GRA strategies
Overseeing vendor responsibility for regulatory activities and submissions related to projects within scope.
In this role you will be required to have:
At least 8 years of Regulatory experience or 6+ years Regulatory and/or related experience
Solid working knowledge of drug development process and regulatory requirements (i.e understanding of broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
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.