Job Description

Job Description

Role: QA / Regulatory Affairs Specialist

Location: St. Petersburg, FL

Duration: 06 months with possible extension

What You’ll Do:

• Manage and review Change Controls and ensure proper documentation.
• Perform regulatory impact assessments and support FDA/state submissions.
• Prepare and submit A/NDA, DMFs, permits, and annual reports.
• Support audits, CAPAs, complaint investigations, and Annual Product Reviews.
• Collaborate with teams on quality events, SOPs, and process improvements.
• Participate in training, compliance reviews, and internal assessments.

What we are looking for:

• Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology);
• A minimum of 3 years related experience in the pharmaceutical manufacturing industry.
• Strong background working with Change Controls and management of change control processes.
• Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred).
• PathWise Certification preferred.
• Prior regulatory affairs, quality control or quality assurance experience is a must.
• Working knowledge of US application regulations and cGMPs, and FDA Guidance for both.
• Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access).
• Working knowledge of cGMPs and/or OSHA regulations required.

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