Regulatory Affairs Specialist

MOLEAC PTE. LTD.

Singapore, Singapore
Not specified (assumed office-based in singapore).
Fluent in english and spanish
Bachelor's degree in life sciences
2-5 years regulatory affairs experience
MOLEAC PTE. LTD. is seeking a Regulatory Affairs Specialist to manage regulatory functions related to their product portfolio, particularly for Spanish-speaking markets. The ideal candidate should have a strong background in regulatory affairs, excellent communication skills, and the ability to navigate complex regulatory environments

Job Summary

  • The role involves preparing and reviewing high-quality regulatory dossiers for new registrations, variations, and renewals across Spanish-speaking markets and the EU.
  • Candidates will collaborate with international partners and internal stakeholders to manage product lifecycle activities and ensure compliance with global regulations.
  • The position requires monitoring regulatory developments, reviewing promotional materials, and supporting clinical trial applications and quality assurance functions.

Matching Summary

Match Score: 85

MOLEAC PTE. LTD. is seeking a Regulatory Affairs Specialist to manage regulatory functions related to their product portfolio, particularly for Spanish-speaking markets. The ideal candidate should have a strong background in regulatory affairs, excellent communication skills, and the ability to navigate complex regulatory environments.

Skills & Requirements

Must-have

  • Fluent in English and Spanish
  • Bachelor's degree in Life Sciences
  • 2-5 years Regulatory Affairs experience
  • Knowledge of ICH, ASEAN, FDA, EMA frameworks

Nice-to-have

  • Experience with food supplements or herbal medicines
  • Familiarity with LATAM regulatory requirements
  • Proficiency in Mandarin or other languages
  • Strong interpersonal and stakeholder management skills

Key Requirements

  • Spanish proficiency required (native or business-level certification)
  • Degree in Life Sciences, Pharmacy, or related discipline
  • Solid understanding of international regulatory frameworks including FDA and EMA

Work Rights

Not specified

Tailored Resume

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