MAIN PURPOSE OF ROLE : + Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function. + First level manager of a work team that may comprise professionals, technical and/or administrative staff. + Typically without budget or hire/fire authority. + Focuses on mentoring, coaching, and coordination. MAIN RESPONSIBILITIES : + As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. + Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout product lifecycle. + Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC). + Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products. + Serves as regulatory representative to marketing, research teams and regulatory agencies. + Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. QUALIFICATIONS : Education + Associates Degree (± 13 years) Experience/Background + Minimum 4 years An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com