Scientific Office&Regulatory Affairs Manager

<div><p><b>Job Title: Scientific Office&Regulatory Affairs Manager</b></p><p><b>Employment Type:</b>Full-time</p><h3>About the Role</h3><p>Bausch&Lomb is a multinational organization with a diverse portfolio of<b>pharmaceutical and medical device products that helps people see better to live better</b>. We are committed to improving patient outcomes and advancing healthcare standards through innovation, quality, and compliance. We are now seeking a highly skilled and motivated<b>Scientific Office&Regulatory Affairs Manager</b>to lead our Saudi scientific and regulatory operations.</p><p>The ideal candidate will oversee scientific office affairs, ensure compliance with Saudi Food and Drug Authority (SFDA) regulations, and support the company’s business objectives by aligning scientific and marketing strategies.</p><h3>Key Responsibilities</h3><ul><li>Manage and oversee all scientific office activities in compliance with Saudi FDA regulations including Scientific office inspection/audit.</li><li>Lobbying with SFDA, GHC and other authorities to accelerate company major projects and objectives.</li><li>Through Scientific office represent the company in front of SFDA and Gulf Health Council in all forums and activities for Pharmaceutical and medical devices.</li><li>Strong professional relationships with regulatory authorities and key stakeholders.</li><li>Coordinate with the regional regulatory affairs teams on new product launches, Saudi projects and other activities that matters to Saudi and rest of Middle East region.</li><li>Manage product registration, renewal, variation submissions on all SFDA systems.</li><li>Ensure compliance with local laws and company policies related to marketing authorization and promotional materials.</li><li>Act as Saudi scientific office point of contact for internal and external stakeholders representing the company with Saudi distributors, tender institutions, SFDA shortage department.</li><li>Mastering and up to date with SFDA regulatory guidelines and intelligence.</li><li>Provide regulatory support to sales, marketing, medical and other cross functional teams.</li><li>Support cross functional team in communication and correspondence submissions with SFDA.</li><li>Manage documentation, and product information updates.</li></ul><h3>Qualifications&Experience</h3><ul><li>Saudi National licensed Pharmacist with bachelor’s degree in pharmacy (Master’s preferred).</li><li>Minimum 5 years of experience in Scientific office management&Regulatory affairs, with at least 2 years in a management role.</li><li>Proven experience working with SFDA on both pharmaceutical and medical device products.</li><li>Strong knowledge of Saudi and GCC regulatory frameworks.</li><li>Excellent communication, negotiation, and leadership skills.</li><li>Fluency in English and Arabic (written and spoken).</li><li>Experience working in a multinational environment is highly desirable.</li></ul></div>#J-18808-Ljbffr