Officer, Regulatory affairs

Location: Sidi Thabet Job Type: CDI About Us For over 45 years, Hikma Pharmaceuticals has been putting better health within reach, every day, by creating high-quality medicines and making them accessible to those who need them. We are helping to shape a healthier world that enriches all our communities, and our global team of 9,500+ empowered employees are central to this mission. As a trusted and reliable partner of over 800 high-quality generics, specialty and branded pharmaceutical products, we are driven to improve access to medicine. Through our 29 manufacturing plants, 9 R&D centers across the MENA, North America and Europe, our footprint allows us to play a critical role in serving patients. Description: We are looking for a talented Officer, Regulatory affairs to join us. At Hikma you’ll be supported by a culture of progress and belonging where people are encouraged to develop, wellbeing is prioritised and our inclusive approach values contributions from all. We’re seeking candidates who embody our values: Innovative, driven to keep learning; Caring, genuinely compassionate in their work; and Collaborative, eager to solve problems together. If you want to be part of a team that cares about impact, this is the place for you. Key Responsibilities • Prepare, review, compile, and maintain regulatory dossiers and supporting documentation in line with applicable requirements. • Manage and follow up on regulatory activities related to new product registrations, renewals, variations, and other post-approval activities. • Support the preparation and submission of regulatory applications to the relevant health authorities and follow up on their progress. • Coordinate responses to questions, requests for additional information, and other communications received from regulatory authorities. • Ensure that product documentation and regulatory records remain accurate, complete, compliant, and up to date. • Contribute to regulatory assessments related to product changes and ensure appropriate regulatory actions are identified and followed. • Monitor changes and developments in the regulatory environment and support the evaluation of their potential impact on products and business activities. • Maintain effective communication and coordination with internal stakeholders, including Quality, Medical, Supply Chain, Marketing, and other relevant functions. • Support the preparation and maintenance of regulatory tracking tools, databases, and documentation. • Participate in cross-functional projects requiring Regulatory Affairs input and ensure regulatory considerations are adequately addressed. • Contribute to maintaining a strong culture of quality, compliance, accuracy, and continuous improvement. Qualifications & Experience • Degree in Pharmacy, Engineering, Life Sciences, Pharmaceutical Sciences, or another relevant scientific discipline. • Previous experience in Regulatory Affairs within the pharmaceutical industry would be highly valued. • Understanding of pharmaceutical product registration processes and regulatory documentation. Key competencies • Strong attention to detail and commitment to accuracy. • Excellent organizational, planning, and follow-up skills. • Ability to manage multiple priorities and work within defined timelines. • Strong analytical and problem-solving capabilities. • Good interpersonal and communication skills. • Ability to collaborate effectively in a cross-functional environment. • Proactive mindset with a strong sense of ownership and accountability. • Good command of English and French, both written and spoken. • Good proficiency in Microsoft Office tools.