Senior/ Regulatory Specialist (Biologics), Therapeutic Products Branch

• Evaluate the Chemistry, Manufacturing and Controls (CMC) data of therapeutic product applications for regulatory approval to assure the quality of medicines supplied in Singapore.
• Provide advice / guidance on the regulatory requirements and procedures for therapeutic product regulatory submissions, and to respond to enquiries from industry and healthcare stakeholders as well as member of public.
• Participate in projects and process/regulatory review.

• A background in Molecular Biology, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Pharmacy or related disciplines. A post-graduate degree in areas such as bioprocess engineering, molecular therapeutics, biologics development or mRNA/ nucleic acid therapeutic drug development would be an advantage.

RELEVANT EXPERIENCE

• Minimum 5-7 years of experience in pharmaceutical manufacturing, quality control, or regulatory assessment of biologics, mRNA products or other nucleic acid-based products.
• Knowledge of biologics development processes, including characterization studies, analytical method development and quality assessment.
• Knowledge of mRNA drug development processes, including lipid nanoparticle formulations, alternative delivery systems and associated manufacturing considerations or equivalent experience with nucleic acid delivery systems and formulation technologies.
• Knowledge of international drug regulations (ICH, FDA, EMA guidelines).
• Experience in analytical method development and validation for biologics would be an advantage.

RELEVANT SKILLS

• Good communication and interpersonal skills.
• Good writing and presentation skills.
• Able to analyse and integrate different sources of information to develop solutions.
• Able to work independently as well as in a team.
• Able to work effectively with people from other backgrounds, internal and external stakeholders.

The successful candidate will be offered a 1-year contract (with option for automatic renewal for a further one year) in the first instance.

Shortlisted candidates would be contacted within 30 days from the closing date of the advertisement. We regret that only shortlisted candidates would be notified.