Regulatory Affairs Specialist
efficient auditingAustin (TX)
About the role
We are seeking a detail-oriented Regulatory Affairs Specialist to support our clients in meeting global regulatory requirements for pharmaceuticals, medical devices, biotechnology products, and life-science operations. This role ensures that all documentation, submissions, and compliance activities align with FDA, EMA, TGA, MHRA, and other international regulatory frameworks.
The ideal candidate has hands‑on experience with regulatory submissions, technical documentation, and lifecycle management, along with a solid understanding of GMP, GDP, and ISO-based quality systems.
Key Responsibilities:
Prepare, review, and manage regulatory submissions (IND, NDA, ANDA, 510(k), CE Marking documentation, variations, renewals, etc.).
Support clients with regulatory strategy development for product registration and approval.
Ensure all regulatory documents are complete, accurate, and audit-ready.
Maintain up-to-date knowledge of global regulatory requirements and changes.
Review quality system documentation for compliance with relevant guidelines (FDA CFRs, ICH, ISO standards).
Coordinate communication with regulatory agencies and assist in responding to queries or deficiencies.
Support clients during inspections, audits, and pre-approval reviews.
Provide regulatory insights for product development, labeling, packaging, and technical documentation.
Collaborate with quality, manufacturing, and R&D teams to maintain compliance throughout product lifecycle.
Qualifications:
Bachelor’s or Master’s degree in Regulatory Affairs, Pharmacy, Biotechnology, Life Sciences, or related discipline.
2–5 years of hands‑on regulatory experience in pharma, medical devices, or biotech.
Strong understanding of FDA regulations, ICH guidelines, EU MDR/IVDR, and other global regulatory frameworks.
Experience preparing or reviewing regulatory submissions and technical documents.
Excellent writing, communication, and project coordination skills.
Ability to interpret complex regulations and provide clear compliance recommendations.
Preferred Skills:
Regulatory Affairs Certification (RAC) is a strong plus.
Experience with eCTD submissions and document management systems.
Familiarity with GMP, GLP, and ISO 13485 environments.
Understanding of risk management, product development processes, and quality systems.
Why Join Us?
Work directly with innovative clients across pharmaceuticals, medtech, and biotechnology sectors.
Build expertise in global regulatory strategy and compliance management.
Collaborative environment with strong opportunities for professional growth.
Competitive compensation, flexible working culture, and exposure to high-impact projects.
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