Regulatory Affairs Specialist

<p>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.</p><p>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.</p><h3>Key Responsibilities</h3><ul><li>Prepare, review, and manage regulatory submissions (IND, NDA, ANDA, 510(k), CE Marking documentation, variations, renewals, etc.).</li><li>Support clients with regulatory strategy development for product registration and approval.</li><li>Ensure all regulatory documents are complete, accurate, and audit-ready.</li><li>Maintain up-to-date knowledge of global regulatory requirements and changes.</li><li>Review quality system documentation for compliance with relevant guidelines (FDA CFRs, ICH, ISO standards).</li><li>Coordinate communication with regulatory agencies and assist in responding to queries or deficiencies.</li><li>Support clients during inspections, audits, and pre-approval reviews.</li><li>Provide regulatory insights for product development, labeling, packaging, and technical documentation.</li><li>Collaborate with quality, manufacturing, and R&amp;D teams to maintain compliance throughout product lifecycle.</li></ul><h3>Qualifications</h3><ul><li>Bachelor’s or Master’s degree in Regulatory Affairs, Pharmacy, Biotechnology, Life Sciences, or related discipline.</li><li>2–5 years of hands‑on regulatory experience in pharma, medical devices, or biotech.</li><li>Strong understanding of FDA regulations, ICH guidelines, EU MDR/IVDR, and other global regulatory frameworks.</li><li>Experience preparing or reviewing regulatory submissions and technical documents.</li><li>Excellent writing, communication, and project coordination skills.</li><li>Ability to interpret complex regulations and provide clear compliance recommendations.</li></ul><h3>Preferred Skills</h3><ul><li>Regulatory Affairs Certification (RAC) is a strong plus.</li><li>Experience with eCTD submissions and document management systems.</li><li>Familiarity with GMP, GLP, and ISO 13485 environments.</li><li>Understanding of risk management, product development processes, and quality systems.</li></ul><h3>Why Join Us?</h3><ul><li>Work directly with innovative clients across pharmaceuticals, medtech, and biotechnology sectors.</li><li>Build expertise in global regulatory strategy and compliance management.</li><li>Collaborative environment with strong opportunities for professional growth.</li><li>Competitive compensation, flexible working culture, and exposure to high-impact projects.</li></ul><br />#J-18808-Ljbffr