Elaine Campbell Email & Phone Number

I am an experienced regulatory affairs professional with extensive knowledge of US, Canadian, European and ROW pharmaceutical regulations. I am an accomplished regulatory author, with exemplary interpersonal skills that make me a highly effective liaison and communicator. I have extensive experience working with FDA and global health authorities, as well as with intraorganizational stakeholders and external CMOs. I have leveraged this experience to create successful partnerships and to complete coherent, concise and persuasive regulatory submissions.My work experience ranges from biopharmaceutical production (cell culture, cell banking, scale-up and drug product development) to lifecycle management of NDAs and global registrations. I have supported new registrations and post-approval maintenance of OTC and prescription pharmaceutical drug products for more than 20 years.