ãEP/CSãSenior Specialist, Regulatory Affairs
ãEP/CSãSenior Specialist, Regulatory Affairs
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Job Description
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/AIn 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 5-6-10TsukijiChuo-ku
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Senior IC
Employment Type
Full-Time
