Senior Specialist, Regulatory Affairs job opportunity at Abbott.

Home Jobs In Japan Tag: Regulatory Affairs Senior Specialist, Regulatory Affairs position at Abbott


DatePosted 30+ Days Ago bot
Abbott Senior Specialist, Regulatory Affairs
Experience: 13-years
Pattern: full-time
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Regulatory Affairs

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degreeAssociate
loacation Japan - Tokyo, Japan
loacation Japan - Tokyo....Japan

      JOB DESCRIPTION: 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       The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Regulatory Operations       DIVISION: MD Medical Devices          LOCATION: Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Not specified       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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