Join Our Team
Are you highly organized, detail-oriented, and passionate about quality and regulatory compliance? We're looking for a Regulatory Affairs / Compliance Specialist to support our Regulatory Affairs and Compliance team by maintaining regulatory documentation, coordinating compliance activities, and ensuring adherence to FDA and state regulatory requirements.
This position is ideal for someone who enjoys working in a fast-paced pharmaceutical manufacturing environment where accuracy, organization, and teamwork are essential.
As a Regulatory Affairs / Compliance Specialist, you will:
- Prepare, route, track, and archive compliance documentation.
- Prepare and maintain regulatory correspondence, including FDA submissions, supplements, and annual reports.
- Maintain regulatory files and documentation.
- Research regulatory requirements and provide information to internal departments and regulatory agencies.
- Track compliance metrics (KPIs), action items, deviations, inspections, complaints, and adverse events.
- Process customer complaints and inquiries while assisting with investigations and final reports.
- Prepare Annual Product Reviews by coordinating information across multiple departments.
- Maintain audit questionnaires and vendor/service provider risk assessments.
- Support internal, customer, regulatory, third-party, and vendor audits.
- Review and maintain Customer Quality Agreements.
- Archive batch records and compliance documentation.
- Review and approve customer labeling materials.
- Assist with FDA registrations, state licensing activities, and other regulatory projects.
- Interface with customers, regulatory agencies, and internal departments regarding compliance matters.
Experience & Education requirements:
- Associate’s degree in sciences or equivalent, bachelor’s degree preferred. 2-5 years of experience in Regulatory Affairs, Compliance, Quality Assurance, Pharmaceutical Manufacturing, or a related field preferred.
We're looking for someone who has:
- Knowledge of FDA regulations and regulatory compliance practices.
- Strong organizational and time management skills.
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- High attention to detail and accuracy.
- Ability to manage multiple priorities in a fast-paced environment.
- Ability to work independently while collaborating across departments.
- Professional interpersonal skills and customer service mindset.
- Proficiency in Microsoft Office, particularly Excel and Word.
Physical Requirements
- Ability to sit, stand, and move throughout an office/manufacturing environment.
- Ability to operate computers, office equipment, and standard technology.
- Ability to read documents and communicate effectively with employees and external agencies.
- Manual dexterity to type, write, and handle documentation.
Why Join Us?
- Opportunity to work in a growing pharmaceutical manufacturing environment.
- Collaborative and supportive team culture.
- Meaningful work that directly supports product quality and regulatory compliance.
- Opportunities for professional growth and development.
Ideal Candidates May Have Experience As:
- Regulatory Affairs Specialist
- Compliance Specialist
- Quality Assurance Specialist
- Documentation Specialist
- Regulatory Coordinator
- Quality Systems Coordinator
- Pharmaceutical Compliance Associate
If you thrive in a detail-driven environment and enjoy ensuring compliance while supporting quality initiatives, we'd love to hear from you! Apply today!
Pay: $60,000.00 - $75,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
