Regulatory Affairs Manager

Job Description:

Main Responsibilities

•

As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals 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 4 Years

Licenses And Certifications

License/Certification

Language Proficiency

Language

Proficiency

Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.

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:

ID Infectious Disease

Location:

Japan > Matsudo-shi : 357 Nakahara, Matsuhidai

Additional Locations:

Work Shift:

Standard

Travel:

Not specified

Medical Surveillance:

Not Applicable

Significant Work Activities:

Not Applicable