CMC Regulatory Affairs Manager - LifeSciences
|Job Title:||CMC Regulatory Affairs Manager - LifeSciences|
|Contact Name:||Jolene Lee|
|Job Published:||August 01, 2021 14:44|
Our client is a leading biotechnology company focused on clinical development of treatments for Infectious Diseases. They are looking to recruit a highly motivated Regulatory Affairs Manager to assist in formulating CMC strategies, preparation of documentation for regulatory submission as well as execution of post-approval CMC supplements and new product registrations, serving as a liaison between with Regulatory Agencies (such as HSA, Singapore) and Manufacturing, Quality and Clinical teams. You will develop regulatory strategies and manage regulatory submissions for new and existing therapeutic pipeline based on guidelines from various agencies (e.g., ICH/FDA/EMA).
Ideally, you have more than 5 years of experience in regulatory affairs with proven experience in end-to-end management of regulatory submissions. This include drafting of relevant submission documentation especially technical documentation related to CMC technical documentation e.g. eCTD/NeeS, tracking of amendments, communications, briefing documents and other supporting documentations. Excellent understanding of current regulatory guidelines (e.g., ICH, US-FDA, EMA) for new drug applications and late stage clinical development. Additional experience in BLA submissions will be a plus. You possess a MSc or PhD in Biochemistry, Biological Engineering, or related Life Science field.
Singapore Employment Agency Licence No: 16S8069
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