Tokyo, JPN
1 day ago
【EP/CS】Senior Specialist, Regulatory Affairs
**_MAIN PURPOSE OF ROLE_** Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. **_MAIN RESPONSIBILITIES_** • As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills 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_ : Associates Degree (± 13 years) **_Experience/Background_** _Experience_ : 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
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