Responsibilities:
- Authoring regulatory submissions: Writing and reviewing the CMC sections for recent 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 regul