MAIN PURPOSE OF THE 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 Education Level Major/Field of Study or Equivalent Associates Degree (± 13 years) Experience/Background Experience Experience Details Minimum 4 years Licenses and Certifications Language Proficiency Language Proficiency Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role. 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