RA Manager

2 weeks ago


Singapore HRnetGroup Singapore Full time

Responsibilities Lead the preparation, compilation, review, and submission of high-quality regulatory dossiers (e.g., eCTD format) to relevant health authorities. Manage timelines and ensure all regulatory milestones and deadlines are met. Monitor, interpret, and communicate current and proposed changes in regulatory guidance, legislation, and industry standards to cross-functional teams. Oversee the management of regulatory documentation and tracking systems. Serve as the primary point of contact and liaison with regulatory agencies for all assigned products/projects. Prepare for and participate in meetings, audits, and inspections by regulatory bodies. Provide expert regulatory guidance and training to internal stakeholders, including Quality Assurance, Clinical Development, and Commercial/Marketing teams. Job Requirements Bachelor’s degree in Pharmacy. Minimum of 8 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry. In-depth knowledge of global regulatory requirements and guidelines (e.g., FDA, EMA, ICH). Proven experience with regulatory submission types. Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly to technical and non-technical audiences. Good in English. 391A Orchard Road, Ngee Ann City Tower A, Unit #23-03Singapore Our goal is to build your talent base and strengthen it by ensuring that you are always equipped with only the best. #J-18808-Ljbffr


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