CK Life Sciences Limited Hiring! Full Time Regulatory Affairs Manager in Hong Kong - Ricebowl

Key Responsibilities:

• Develop and implement regulatory strategies to support RNA-based oncology vaccine programs from preclinical development through clinical stages

• Provide strategic regulatory guidance to development teams and senior management, identify and mitigate regulatory risks proactively

• Lead preparation, coordination, review and submission of IND applications and associated amendments

• Ensure submission components meet health authority requirements and quality expectations

• Lead interactions with FDA and other health authorities, including Pre-IND, Type B, Scientific Advice and other regulatory meetings, coordinate the preparation of briefing packages and meeting responses

• Monitor the evolution on regulations and guidance relevant to oncology, vaccines, RNA therapeutics and advanced biologics

Requirements:

• Bachelor's degree or above in Pharmacy, Life Sciences, Biotechnology, Immunology, Regulatory Affairs or related scientific discipline

• 5 years or above Regulatory Affairs work experience within biotechnology, pharmaceutical, vaccine or advanced therapeutics industries

• Preferring qualifications / experience / technical skills in :

  1) mRNA therapeutic products

  2) Cancer immunotherapy programs

  3) Personalized neoantigen vaccine development

  4) Lipid nanoparticle (LNP) platforms

  5) Global clinical trial applications (CTA/IND/IMPD)

  6) Regulatory activities across FDA, EMA, MHRA, and Asia-Pacific jurisdictions

• A strong understanding in FDA IND regulations, ICH guideline and oncology drug / Vaccine/ RNA therapeutics development

• Familiar with eCTD publishing and submission management system

Thank you for your interest in a career with CK Life Sciences. Competitive compensation and benefits package will be offered to the right candidate. We operate a 5-day workweek. Regular shuttle bus service is also provided with pick-ups and drop-offs at designated and convenient locations.

To apply for our position, please click the QUICK APPLY button. For more company information, please visit *************

We are an equal opportunity employer and welcome applications from all qualified candidates. Personal data collected will be treated in strictest confidence and handled confidentially by authorized personnel for recruitment-related purposes within the Group.