Regulatory Affairs Executive

HAW PAR HEALTHCARE LIMITED; Singapore; On-site; SGD 100,000 - 125,000; Full time

Job summary

A healthcare company in Singapore is seeking a Regulatory Affairs Specialist to support the development and execution of regulatory strategies. Responsibilities include preparing regulatory dossiers, collaborating with cross-functional teams, and ensuring compliance with evolving requirements. Candidates should have a Bachelor's degree in Pharmacy, Chemistry, or Lifesciences, along with at least 2 years of relevant experience in a regulated environment. This role requires strong analytical skills and effective time management.

Qualifications

• Minimum 2 years of relevant experience in a regulated environment, preferably in OTC, cosmetics, or consumer health products.
• Familiarity with ASEAN/EU and ICH regulatory guidelines.
• Experience with European cosmetics and herbal products is an advantage.
• Detail-oriented and proactive, with strong analytical skills and excellent written and verbal communication abilities.
• A collaborative team player able to manage multiple tasks and projects simultaneously.

Responsibilities

• Support development and execution of regulatory strategies aligned with strategic priorities.
• Prepare regulatory dossiers for new registrations and renewals in compliance with requirements.
• Collaborate with cross-functional teams to ensure regulatory compliance across product lifecycle.
• Monitor and report submission statuses using project management tools.
• Communicate regulatory approvals to cross-functional teams and ensure accurate documentation.
• Stay informed of evolving regulatory requirements and assess their impact.

Education

Bachelor’s degree in Pharmacy, Chemistry or Lifesciences

Job description

Job Description

1. Support development and execution of regulatory strategies aligned with Haw Par’s strategic priorities.
2. Prepare regulatory dossiers for new registrations, variations and renewal submissions to authorities in compliance with current regulatory requirements.
3. Collaborate with cross-functional teams including Marketing, Quality, R&D and subsidiary sites’ RA team, and external stakeholders- to ensure regulatory compliance across product lifecycle activities such as artwork and labeling, claims substantiation, health authority queries, new product development, and change controls.
4. Monitor and report submission statuses in real time using the RA department’s project management tools; proactively follow up, anticipate potential issues, and implement solutions (in consultation with supervisor) to ensure timely approvals.
5. Communicate regulatory approvals promptly to cross-functional teams and ensure accurate documentation of approval records in regulatory databases and repositories.
6. Stay informed of evolving regulatory requirements; assess and communicate their impact and support the supervisor in driving necessary actions to maintain compliance.

Requirement

• Bachelor’s degree in Pharmacy, Chemistry or Lifesciences.
• Minimum 2 years of relevant experience in a regulated environment, preferably in OTC, cosmetics, or consumer health products.
• Familiarity with ASEAN/EU and ICH regulatory guidelines.
• Experience with European cosmetics and herbal products is an advantage.
• Detail-oriented and proactive, with strong analytical skills and excellent written and verbal communication abilities.
• A collaborative team player with strong interpersonal skills; able to manage multiple tasks and projects simultaneously with effective time management.