Senior/ Regulatory Specialist (Biologics), Therapeutic Products Branch at Public Service Division

, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

13 Jul, 26

Salary

0.0

Posted On

14 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Chemistry, Manufacturing, Controls, Regulatory assessment, Biologics, Molecular biology, Biochemistry, Biotechnology, Chemical engineering, Pharmacy, Analytical method development, Validation, Communication, Writing, Presentation, Data analysis

Industry

IT Services and IT Consulting

Description

[What the role is] Quality Evaluation of Therapeutic Products [What you will be working on] 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. [What we are looking for] 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. http://jobs.careers.gov.sg The Singapore Public Service plays a key role in the economic growth, progress and stability of Singapore by formulating and implementing government policies, as well as providing key public services. Whether you are a fresh graduate joining the workforce or an experienced professional, the Singapore Public Service offers a great variety of job opportunities for you. The work in the Public Service can be broadly categorised into the following sectors: Economic, Social, Security & External Relations, and Administration & Corporate Development. Be part of the team that shapes the future of Singapore. Log on and take your first step towards a career that matters! Need help? Please click here for assistance. Our team will contact you shortly!

Responsibilities

Evaluate Chemistry, Manufacturing and Controls (CMC) data for therapeutic product applications to ensure regulatory compliance and quality. Provide expert guidance on regulatory requirements to industry stakeholders and the public while participating in process reviews.