Title: Regulatory CMC Manager
Location: Singapore
Overview: One of the leading global biotech is looking to build their team for their manufacturing operations in Singapore. This is an exciting opportunity to be part of the latest biologics development and take charge of the regulatory activities.
Responsibilities of a Regulatory CMC Manager:
- Work closely with global regulatory stakeholders to ensure that local processes are aligned with global standards
- Serve as the main person of contact with local authorities to ensure smooth delivery of objectives and project timeline
- Serve as the subject matter expert in local regulatory landscape to analyse impact for biologics products
- Lead regulatory compliance activities including technical documentation, CAPAs and change control
- Develop and carry out to enable manufacturing operations in the local plant
Requirements:
- Bachelor's degree in sciences or relevant field
- Relevant experience in Regulatory CMC in the biologics field
- Relevant experience working closely with local authorities and local regulatory standards
- Strong knowledge of pharmaceutical regulatory frameworks
- Good communication skills and fluency in English
Benefits and Perks:
- Being part of a leader in the biotech space
- Competitive compensation package
If you are interested in the regulatory CMC manager role, please apply by sending in your CV!
