Regulatory Affairs - Aggregate Safety Report

As a Regulatory Affairs Specialist, you will be responsible for preparing and maintaining Aggregate Safety Reports (ASRs) in compliance with regulatory guidelines. Your key responsibilities will include: - Collaborating with cross-functional teams to gather necessary data and analyses. - Ensuring compliance with applicable regulations and internal policies. - Identifying and assessing safety signals, and reporting findings to relevant stakeholders. - Reviewing and interpreting clinical trial data and safety information. - Assisting in the preparation and submission of regulatory documents to health authorities. - Providing expert advice and guidance on regulatory matters. - Identifying potential regulatory issues and proposing solutions. - Maintaining up-to-date knowledge of evolving regulatory requirements. - Developing and implementing risk management strategies. - Conducting training sessions on regulatory compliance for internal teams. - Participating in audits and inspections as required. - Supporting project management activities related to regulatory submissions. - Documenting processes and maintaining accurate records. - Communicating effectively with external regulatory agencies. Qualifications required for this role include: - Bachelor's degree in Life Sciences, Pharmacy, or a related field. - 4+ years of experience in regulatory affairs or a related field. - Strong understanding of regulatory guidelines and safety reporting. - Experience with Aggregate Safety Reports is highly desirable. - Excellent written and verbal communication skills. - Proficiency in data analysis and interpretation. - Attention to detail and ability to work under tight deadlines. - Strong organizational and multitasking abilities. - Ability to work independently as well as part of a team. - Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). - Experience in conducting regulatory training. - Knowledge of clinical development processes. - Understanding of pharmacovigilance best practices. - Ability to manage projects effectively within specified timelines. - Commitment to continuous learning and professional growth. Your skills in clinical development processes, team collaboration, regulatory compliance, project management, and pharmacovigilance will be crucial for success in this role.,