Job Title: Quality and Regulatory Affairs Specialist

Location: Onsite

Duration: 6 months (with potential extension)

Shift: Monday - Friday, 8 AM - 5 PM or 9 AM - 6 PM

Education and Experience:

• Education: Bachelor’s Degree in Science or a related field (Chemistry, Microbiology, or Biology).
• Experience: Minimum of 3 years in the pharmaceutical manufacturing industry with a strong background in Change Controls and management of change control processes.

Basic Function:

The Quality and Regulatory Affairs Specialist is responsible for providing quality and regulatory affairs services, including Drug Master File (DMF) updates, GMP requests from Health Authorities, customer product complaint investigations, annual product reviews, and management of Change Control and CAPA programs. This role interacts with various departments and prepares regulatory submissions to support site registrations and permits.

Specific Activities and Responsibilities:

• Regulatory Submissions:
• Prepare and submit A/NDA submissions, drug master files, plant/site master files, licenses, permits, and registrations to meet FDA and state requirements (especially Florida).
• Submit federal, state, and local permits in a timely manner.
• Gather and provide information to support customer registration activities.
• Change Control:
• Provide regulatory impact assessments on all change controls.
• Review change control notifications to determine the impact on regulatory filings.
• Quality Systems:
• Assist in preparing and reviewing SOPs associated with job functions.
• Participate in regulatory/health authority audits and collect information as requested.
• Collaborate with SMEs and other personnel to resolve product quality issues, including CAPA initiation and follow-up.
• Annual Product Reviews (APRs):
• Prepare APRs according to site procedures and timelines.
• Assess product complaints and APR trends, provide guidance, and collaborate on action plans.
• Complaint Investigations:
• Prepare complaint investigation reports and work on site events to verify the scope of investigations, assure root cause analysis, and recommend corrective actions.
• Ensure on-time closure of investigations.
• Customer Liaison:
• Ensure customer requirements are met and facilitate CAPA commitments and effectiveness checks.
• Documentation:
• Author and compile monthly, quarterly, and annual summaries and metrics.
• Additional Duties:
• Support site management in enforcing cGMPs.
• Mentor individuals in compliance.
• Participate in internal assessments and facilitate routine compliance and CAPA Review Board meetings.

Requirements:

• Skills:
• Strong understanding of regulatory requirements and processes.
• Excellent communication skills, both written and oral.
• Ability to work collaboratively in a team environment.
• Strong organizational skills and attention to detail.
• Technical Proficiency:
• Proficient in Microsoft Office applications.
• Experience with SAP and other relevant software is a plus.

Work Environment:

• Physical Requirements:
• Ability to lift loads up to 25 lbs.
• Must adhere to safety protocols, including wearing appropriate PPE in the lab.
• Travel:
• Some travel to manufacturing sites may be required.

This position offers the opportunity to work in a dynamic and fast-paced environment, supporting the quality and regulatory affairs functions of a leading pharmaceutical company.