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Jobs in Singapore   »   Jobs in Singapore   »   Regulatory Affairs Specialist
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Regulatory Affairs Specialist

Moleac Pte. Ltd.

Moleac Pte. Ltd. company logo

The Regulatory Affairs (RA) Specialist contributes to all regulatory functions for Moleac products such as obtaining marketing authorisations and product life-cycle management for the global market, and assigned projects.

The candidate demonstrates consistent and excellent interpersonal and communication skills along with ability to thinking critically, problem-solve and collaborate effectively with internal stakeholders.

Key Responsibilities

  • Prepare and review registration/ variations dossiers for submission to regulatory authorities, ensuring scientific rigour, consistency and accuracy of product information, alongside good documentation practice
  • Coordinate with partners and regulatory consultants abroad to support overseas registration, in accordance to company strategy and timeline
  • Collaborate with stakeholders and contribute actively to all aspects of product life cycle management, ensuring compliance to applicable regulatory and quality requirements and continuity in commercialisation
  • Maintain and build on existing database of applicable health product regulations, standards, and guidance documents, interpreting emerging regulations and developments to assess impact on products
  • Review promotional material developed for commercial activities to ensure compliance to applicable regulatory guidelines
  • Participate in local and overseas regulatory inspections and internal audits when applicable
  • Develop and maintain effective relations with local authorities and industry associations Provide regulatory inputs and support to clinical trials and ethics committee submission
  • Assist in GDP and relevant quality assurance matters

Personal Attributes/ Core Competencies

  1. Highly-organised and self-disciplined
  2. Resourceful, with analytical and problem-solving skills
  3. Able to prioritize and work well in fast-paced environment
  4. A team player with excellent interpersonal skills
  5. Proficiency in English (both written and spoken). Additional language such as Mandarin is a strong plus to liaise with external CMOs and partners

Qualifications

  1. Degree in life sciences, with min. 1 – 5 years of relevant work experience
  2. Knowledge in international regulatory guidelines such as ICH, ASEAN, USFDA, EU etc. Regulatory experience with food supplement/ herbal medicine in Europe, North America or Asia Pacific would be advantageous.
  3. Good understanding in GMP, GDP and relevant quality management systems desirable

Application process:

To apply, send your cover letter and resume at f[email protected]

Incomplete application will not be reviewed.

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