Scientific Office & Regulatory Affairs Manager

Job Title: Scientific Office & Regulatory Affairs ManagerEmployment Type: Full-timeAbout the RoleBausch & Lomb is a multinational organization with a diverse portfolio of pharmaceutical and medical device products that helps people see better to live better. 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 Scientific Office & Regulatory Affairs Manager to lead our Saudi scientific and regulatory operations.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.Key ResponsibilitiesManage and oversee all scientific office activities in compliance with Saudi FDA regulations including Scientific office inspection/audit.Lobbying with SFDA, GHC and other authorities to accelerate company major projects and objectives.Through Scientific office represent the company in front of SFDA and Gulf Health Council in all forums and activities for Pharmaceutical and medical devices.Strong professional relationships with regulatory authorities and key stakeholders.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.Manage product registration, renewal, variation submissions on all SFDA systems.Ensure compliance with local laws and company policies related to marketing authorization and promotional materials.Act as Saudi scientific office point of contact for internal and external stakeholders representing the company with Saudi distributors, tender institutions, SFDA shortage department.Mastering and up to date with SFDA regulatory guidelines and intelligence.Provide regulatory support to sales, marketing, medical and other cross functional teams.Support cross functional team in communication and correspondence submissions with SFDA.Manage documentation, and product information updates.Qualifications & ExperienceSaudi National licensed Pharmacist with bachelor’s degree in pharmacy (Master’s preferred).Minimum 5 years of experience in Scientific office management & Regulatory affairs, with at least 2 years in a management role.Proven experience working with SFDA on both pharmaceutical and medical device products.Strong knowledge of Saudi and GCC regulatory frameworks.Excellent communication, negotiation, and leadership skills.Fluency in English and Arabic (written and spoken).Experience working in a multinational environment is highly desirable.#J-18808-Ljbffr