Regulatory QA & Change Control Specialist

ALLTECH CONSULTING SVC INC; Saint Petersburg (FL); On-site; USD 65,000 - 85,000; Full time

Job summary

A pharmaceutical consulting firm located in Saint Petersburg, Florida, is seeking a Regulatory Affairs Specialist. This role involves coordinating change controls, preparing regulatory submissions, and ensuring compliance with FDA and state regulations. Candidates should have a Bachelor's Degree in Science and at least 3 years of experience in the pharmaceutical manufacturing industry. Strong regulatory affairs experience and excellent communication skills are essential for success in this position.

Qualifications

• Minimum of 3 years related experience in the pharmaceutical manufacturing industry.
• Prior experience with investigation writing and report writing.
• PathWise Certification preferred.

Responsibilities

• Coordinate and track change controls to ensure compliance.
• Prepare and submit regulatory submissions to the FDA.
• Assist in regulatory audits and prepare SOPs.

Skills

Regulatory affairs experience

Change control management

Root cause analysis

Communication skills

Microsoft Office proficiency

Education

Bachelor’s Degree in Science

Job description

A pharmaceutical consulting firm located in Saint Petersburg, Florida, is seeking a Regulatory Affairs Specialist. This role involves coordinating change controls, preparing regulatory submissions, and ensuring compliance with FDA and state regulations. Candidates should have a Bachelor's Degree in Science and at least 3 years of experience in the pharmaceutical manufacturing industry. Strong regulatory affairs experience and excellent communication skills are essential for success in this position.