Regulatory Operations Executive (Third-Party Payroll)

Qualification:

Bachelor’s degree in Pharmacy or Life Sciences or relevant education

Years of Experience

1-2 years of Regulatory Affairs

Function:

Regulatory Operations (RegOps)

Shift working:

11:00 am - 19:15 pm or 12:00 pm to 20:15 pm

Competencies:

1. Excellent oral and written communication skills

2. Effective planning, prioritization, organisation and coordination skills

3. Excellent interpersonal skills

4. Knowledge of Google tools and Microsoft Office

5. Teamwork and Collaboration

6. Knowledge of Regulatory landscape is desirable

Key responsibilities
and accountability:

• Dossier Management: Assemble and compile comprehensive regulatory dossiers required for product launches in the APAC region (except China), ensuring all documentation is accurate and submitted on schedule.

• Cross-Functional Collaboration: Work closely with Regulatory, International Export, Marketing, and R&D teams to streamline the flow of information and ensure project alignment.

• Compliance & Artwork Review: Lead the review of product artwork for Filorga cosmetic products, ensuring 100% compliance with EU and North American (NA) labeling requirements.

• Safety Coordination: Partner with external Toxicology teams to facilitate safety assessments for products under development by providing necessary data and technical specifications in a timely manner.

• Process Documentation: Assist in drafting and updating Standard Operating Procedures (SOPs) and Work Instructions for new regulatory activities to ensure organizational consistency.

• Tracking & Communication: Maintain product information archives and tracking tools. Proactively communicate potential bottlenecks or regulatory risks to leadership to prevent project delays.