MAIN PURPOSE OF ROLE + Senior para-professional individual contributor that is fully proficient in applying established standards. + Knowledge base acquired from several years of experience in the area of Regulatory Affairs. + Works independently. + May instruct or coach other para-professionals. MAIN RESPONSIBILITIES + As the Senior para-professional in the Regulatory Affairs Sub-Function, possesses advanced knowledge 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 labelling, appropriate regulations and interpretations. QUALIFICATIONS + Technical Diploma (± 12 years) + Minimum 1 year experience 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