Sr. RA Specialist job opportunity at Abbott.



DateMore Than 30 Days Ago bot
Abbott Sr. RA Specialist
Experience: 13-years
Pattern: full-time
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degreeAssociate
loacation China - Shanghai, China
loacation China - Shangh..........China

      JOB DESCRIPTION: MAIN PURPOSE OF ROLE Summarize the main purpose of the 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    Major/Field of Study    Or    Education Level Associates Degree (± 13 years)        ☐        Experience/Background Experience    Experience Details 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: ADC Diabetes Care          LOCATION: China > Shanghai : 388 W. Nanjing Road, Ciros Plaza       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Not specified       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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