5th HQ
5th HQ
We are seeking a
detail-oriented and highly organized Regulatory Technician
to join our team. This role is responsible for ensuring
compliance with FDA regulations
and maintaining regulatory documentation related to
manufacturing, packaging, labeling, and holding operations
for dietary supplements. The ideal candidate should have
strong technical writing skills, regulatory knowledge, and experience in a cGMP-controlled environment. Minimum Qualifications
High school diploma required
(Pharmaceutical or related industry experience preferred). cGMP training and orientation programs
completed (prior experience in cGMP manufacturing is a plus). Strong
technical writing and verbal communication skills.
Ability to
manage multiple tasks and meet deadlines. Proficiency in MS Office
(Word, Excel, PowerPoint) and
ERP systems. Key Responsibilities
Ensure compliance with
FDA regulations (21 CFR Part 111)
for manufacturing, packaging, labeling, and holding of dietary supplements. Manage
accreditations, certifications, licenses, and permits
from federal and international agencies. Review and determine
regulatory compliance
for all labeling and packaging components. Serve as
Regulatory Intelligence
by staying up to date on FDA regulations and industry practices. Prepare and maintain
customer quality questionnaires. Keep management informed of
new FDA regulations and industry developments. Work with department managers to coordinate
updates to procedures and documentation. Maintain and ensure the
safe storage and inventory of labels. Control the
issuance and return of labels
within the packaging department. Coordinate and implement
GMP training programs
and conduct sessions when necessary. Maintain all
training documentation
in accordance with company policies. Prepare
technical submissions for international product registration. Oversee the status and maintenance of
trademarks, registrations, and patents. Perform
other duties as assigned
by the immediate supervisor.
#J-18808-Ljbffr
We are seeking a
detail-oriented and highly organized Regulatory Technician
to join our team. This role is responsible for ensuring
compliance with FDA regulations
and maintaining regulatory documentation related to
manufacturing, packaging, labeling, and holding operations
for dietary supplements. The ideal candidate should have
strong technical writing skills, regulatory knowledge, and experience in a cGMP-controlled environment. Minimum Qualifications
High school diploma required
(Pharmaceutical or related industry experience preferred). cGMP training and orientation programs
completed (prior experience in cGMP manufacturing is a plus). Strong
technical writing and verbal communication skills.
Ability to
manage multiple tasks and meet deadlines. Proficiency in MS Office
(Word, Excel, PowerPoint) and
ERP systems. Key Responsibilities
Ensure compliance with
FDA regulations (21 CFR Part 111)
for manufacturing, packaging, labeling, and holding of dietary supplements. Manage
accreditations, certifications, licenses, and permits
from federal and international agencies. Review and determine
regulatory compliance
for all labeling and packaging components. Serve as
Regulatory Intelligence
by staying up to date on FDA regulations and industry practices. Prepare and maintain
customer quality questionnaires. Keep management informed of
new FDA regulations and industry developments. Work with department managers to coordinate
updates to procedures and documentation. Maintain and ensure the
safe storage and inventory of labels. Control the
issuance and return of labels
within the packaging department. Coordinate and implement
GMP training programs
and conduct sessions when necessary. Maintain all
training documentation
in accordance with company policies. Prepare
technical submissions for international product registration. Oversee the status and maintenance of
trademarks, registrations, and patents. Perform
other duties as assigned
by the immediate supervisor.
#J-18808-Ljbffr