Regulatory Affairs Executive/ Manager

RECRUIT123 PTE. LTD.; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

RECRUIT123 PTE. LTD. is helping a growing pharmaceutical company in Singapore recruit a Regulatory Affairs Specialist/Manager to lead drug submissions and ensure ongoing compliance.

The role requires hands-on CTD/eCTD submissions, regulatory strategy across markets, and mentoring of junior staff. You will liaise with HSA/regional authorities, coordinate with R&D and QA, and manage multiple projects with tight deadlines in a dynamic environment.

Qualifications

• 2–5 years in pharmaceutical regulatory affairs (specialist)

Responsibilities

• Prepare and submit regulatory dossiers for new registrations and variations
• Ensure lifecycle compliance (GMP, pharmacovigilance, labeling)
• Liaise with HSA and regional authorities on submissions and approvals
• Review labeling, packaging inserts, and promotional materials
• Monitor regulatory changes across markets and assess impact
• Collaborate with R&D, QA, and commercial for launches
• Support adverse event reporting and pharmacovigilance docs
• Maintain regulatory records and submission trackers
• Lead and mentor junior staff; manage regulatory strategy for portfolio

Skills

CTD/eCTD submissions

HSA regulations

ASEAN ACTD

Regulatory strategy

Team leadership

Cross-functional liaison

Education

Bachelor's degree in Pharmacy or Life Sciences

Tools

PRISM

Job description

Regulatory Affairs Specialist / Manager

Job Description:

Recruit123 is helping our client to hire a Regulatory Affairs Specialist/Manager. Our client is a growing pharmaceutical company, seeking a regulatory affairs professional to manage drug product registrations and ensure ongoing regulatory compliance across relevant markets.

Responsibilities:

• Prepare, compile, and submit CTD/ACTD-format regulatory dossiers for new drug registration, renewal, and variation applications with HSA and other regional health authorities
• Ensure pharmaceutical products remain compliant with applicable regulatory guidelines throughout the product lifecycle (GMP, pharmacovigilance, labelling requirements)
• Liaise with HSA and regional regulatory bodies on submission queries, product approvals, and post-market surveillance requirements
• Review drug labelling, packaging inserts, and promotional materials for regulatory compliance
• Monitor changes in pharmaceutical regulatory requirements across markets and assess impact on the product portfolio
• Collaborate with R&D, quality assurance, and commercial teams to support new drug launches and lifecycle management
• Support adverse event reporting and pharmacovigilance documentation where required
• Maintain accurate regulatory documentation, submission trackers, and product registration records
• (Manager level) Lead and mentor junior regulatory affairs staff; own regulatory strategy across a drug product portfolio; manage relationships with external regulatory consultants, CROs, and distributors across multiple markets

Requirements:

• Degree in Pharmacy, Life Sciences, Pharmaceutical Science, or related field
• Specialist: 2-5 years' relevant pharmaceutical regulatory affairs experience; Manager: 6+ years' relevant experience with prior team or portfolio management exposure
• Sound knowledge of HSA drug registration requirements and regional pharmaceutical regulatory frameworks (e.g. ASEAN ACTD, other applicable jurisdictions)
• Familiarity with CTD/eCTD dossier compilation and submission processes
• Strong attention to detail and ability to manage multiple drug submissions/deadlines concurrently
• Excellent written and verbal communication skills for liaising with health authorities and cross-functional teams
• Experience with electronic submission platforms (e.g. PRISM) and regulatory databases is a plus