**_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_** _- Education Level_ Technical Diploma (± 12 years) _- Experience Details_ Minimum 1 year 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