Senior Associate/Strategist – Regulatory Affairs (APAC CMC)

About this role

<h2><strong>Responsibilities:</strong></h2> <ul> <li><strong>Authoring regulatory submissions</strong>: Writing and reviewing the CMC sections for new e.g. New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs) and lifecycle maintenance regulatory filings including responses to Health Authority’s questions.</li> <li><strong>Ensuring regulatory compliance</strong>: Making sure that all documents align with the requirements of regulatory bodies as well as International Council for Harmonisation (ICH) guidelines.</li> <li><strong>Collaborating with subject matter experts (SMEs)</strong>: Working closely with scientists, quality assurance (QA), manufacturing teams, and regulatory affairs colleagues to gather accurate and complete information about a drug's composition, manufacturing process, and quality control.</li> <li><strong>Maintaining document quality</strong>: Ensuring completion of high-quality documents i.e.  clear, concise, scientifically accurate, and consistent in style and format, complying with regulatory guidelines and internal processes within timelines.</li> <li><strong>Managing timelines</strong>: Adhering to strict project schedules to ensure timely completion of submissions. </li> <li><strong>Identify, Assess and Communicate potential CMC Regulatory issues and propose mitigation strategies</strong>.</li> <li><strong>Understands, interprets and guides teams on regulations and policies related to manufacture and control of medicinal products to expedite the submission, review and obtain approvals.  </strong></li> </ul> <p> </p> <p><strong>Essential skills and qualifications</strong></p> <ul> <li><strong>Educational background</strong>: A bachelor's degree or higher in a scientific field, such as Chemistry, Pharmaceutical Sciences, or a related discipline.</li> <li><strong>Experience</strong>: Minimum of 5 ~ 9 years of relevant work experience working within a Regulatory Affairs Department with direct accountability for deliverables.</li> <li><strong>Pharmaceutical experience</strong>: Prior experience authoring CMC sections for regulatory submissions is a standard requirement.</li> <li><strong>Technical writing expertise</strong>: Exceptional technical writing, editing, and communication skills are required to translate complex scientific data into clear regulatory documentation.</li> <li><strong>Regulatory knowledge</strong>: A strong knowledge of CMC regulatory requirements for multiple global regions (e.g., APAC, U.S., EU) is essential. Experience with the electronic Common Technical Document (eCTD) format is also crucial.</li> <li><strong>Industry familiarity</strong>: A background in pharmaceutical manufacturing or quality control is often beneficial.</li> <li><strong>Collaboration and project management</strong>: The ability to work independently, manage projects, and communicate effectively with cross-functional teams is critical.</li> <li><strong>Detail-oriented</strong>: Meticulous attention to detail is necessary to ensure the accuracy and completeness of submissions. </li> </ul> <p> </p> <p> </p>