Responsibilities:

Authoring regulatory submissions: 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.
Ensuring regulatory compliance: Making sure that all documents align with the requirements of regulatory bodies as well as International Council for Harmonisation (ICH) guidelines.
Collaborating with subject matter experts (SMEs): 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.
Maintaining document quality: 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.
Managing timelines: Adhering to strict project schedules to ensure timely completion of submissions.
Identify, Assess and Communicate potential CMC Regulatory issues and propose mitigation strategies.
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.

Essential skills and qualifications

Educational background: A bachelor's degree or higher in a scientific field, such as Chemistry, Pharmaceutical Sciences, or a related discipline.
Experience: Minimum of 5 ~ 9 years of relevant work experience working within a Regulatory Affairs Department with direct accountability for deliverables.
Pharmaceutical experience: Prior experience authoring CMC sections for regulatory submissions is a standard requirement.
Technical writing expertise: Exceptional technical writing, editing, and communication skills are required to translate complex scientific data into clear regulatory documentation.
Regulatory knowledge: 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.
Industry familiarity: A background in pharmaceutical manufacturing or quality control is often beneficial.
Collaboration and project management: The ability to work independently, manage projects, and communicate effectively with cross-functional teams is critical.
Detail-oriented: Meticulous attention to detail is necessary to ensure the accuracy and completeness of submissions.

Senior Associate/Strategist – Regulatory Affairs (APAC CMC)