Snr Regulatory Specialist/Consultant (Clinical), Therapeutic Products Branch

Clinical evaluation of therapeutic product registration submissions Responsibilities • Evaluate clinical data submitted by pharmaceutical companies and provide technical advice on data requirements for therapeutic product registration applications. • Develop scientific opinions and position papers on evolving regulatory approach and technical requirements. • Represent HSA at external engagements, including meeting with sponsors, technical and advisory committees. • Foster partnership with international regulatory authorities through collaborative review and information sharing activities. • Serve as HSA's technical expert and front scientific discussions for workshare projects with international regulators. • Represent HSA at international regulatory forums, contributing to development of regulatory guidelines and standards. Requirements A background in Medicine, Pharmacy or related discipline with relevant experience in immunology or oncology. RELEVANT EXPERIENCE • Minimum 7 - 10 years' experience in clinical pharmacy, medical practice, or clinical-related regulatory work. • Professional background in clinical practice or research, with knowledge of clinical practice guidelines. • Good understanding of pharmaceutical legislation and regulatory frameworks, with the ability to interpret and apply complex scientific and clinical information to inform regulatory and policy decisions. • Experience in supporting policy development initiatives, process improvements and contributing to policy decisions. RELEVANT SKILLS • Excellent written and verbal communication abilities with attention to detail and the capacity to convey scientific matters clearly to diverse audiences, including senior decision-makers. • Strong relationship-building skills with the ability to engage effectively with diverse stakeholders and foster productive collaborative partnerships across various sectors. • Ability to analyse and integrate different sources of information to develop solutions. • Ability to take responsibility for individual and team performance, monitor workflow progress and consistently deliver quality outcomes within demanding timeframes whilst maintaining high standards. • Highly motivated with strong desire to protect public health and safety. The successful candidate will be offered a 1-year contract (with option for automatic renewal for a further one year) in the first instance. Shortlisted candidates would be contacted within 30 days from the closing date of the advertisement. We regret that only shortlisted candidates would be notified.