Regulatory Affairs Specialist

Position Overview:

Responsible for compliance with FDA, and other federal, state and local regulations on facilities/products registration, air and water pollution, waste disposal, and chemical releases; deals with regulatory agencies, develops compliance strategies, directs related training efforts.

Major Functional Objectives:

1.) To Contact and liaison with local, state and federal regulatory agencies for facilities and products licensing, registration, and recall.

2.) To establish and maintain Facility registration product submission packages, supplements, annual reports, drug listing, licensing, and others.

3.) To review and provide final approval to label design and other related publications to ensure compliance with codes or guidelines required by regulatory agencies.

4.) To prepare and review regulatory documents submission such as annual report, CBE-30.

5.) To assist in maintaining department budget and process purchase requisition and cash requisition.

6.) To act as project coordinator to conduct product sourcing, screening, scheduling of Product Research and development and registration and licensing, and maintains related records, files, list of existing products and products under development or consideration.

7.) To investigate and adjust customer complaints regarding quality. May assist in training activities.

8.) To complete assist new projects assigned by upper management team.

9.) Performs other duties, as assigned.

Basic Requirements:

MS office proficiency

Excellent verbal and written skills

Strong typing skills

Chinese speaking and writing is a plus

Education and/or relevant experience:

Bachelor’s degree in science or relevant related field

One year of related industry experience

Compensation:

To apply for this position, please send resume to View email address on carlsbadtech.com.