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.

QUALIFICATIONSEducation
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 5-6-10,Tsukiji,Chuo-ku

ADDITIONAL LOCATIONS: ##WORK SHIFT:
Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable