Regulatory Affairs - Singapore - Kemin

Kemin
Kemin
Verified Company
Singapore

2 weeks ago

Wei Jie

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Wei Jie

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Description

Overview:
LI-KT1


Responsibilities:


  • Manage and coordinate research projects and work with project team toprepare project plan, budget and timelines.
  • Oversee project progress, ensure project execution and completion to meet setcriteria and product quality, within allocated timelines.
  • Facilitate communication and collaboration among all project stakeholders, i.e.,conduct team meetings to discuss project status, updates, issues and solution.
  • Track project progress against milestones and report project progressregularly to the management and all internal stakeholders.
  • Collate technical and management reports from internal stakeholders, andensure reports provided contain relevant information for timely productregistrations.
  • Review publication materials such as marketing documents, technicalcollaterals to ensure accuracy and compliance with policies and regulations inthe APAC markets.
  • Generate comprehensible and clear product information leaflets.
  • Develop and enforce research policies and procedures.
  • Offer advice about company's policies and practices eg. product labelling,regulatory landscape, product innovation processes, intellectual property matters,etc.
  • Conduct due diligence on agreements and collaterals to protect company'sintellectual property and business interests.
  • Assist in product registration and regulatory dossier submissions.

Qualifications:

  • Degree in Science (Biochemistry/Chemistry/Microbiology/Food Science/Biotechnology/Biomedical science/ Pharmaceutical Science etc.) or equivalentfrom a reputable University
  • PMP Certification is an advantage

SKILLS & EXPERIENCE:


  • 36 years of project management experience
  • Ability to understand advanced scientific data and information in order to generate dossiers for regulatory submission.
  • Selfmotivated and meticulous with good organizational and negotiation skills
  • Must have high level of integrity to handle confidential business information
  • Good writing and communication skills
  • Must be able to work independently in a fastpaced multidisciplinary environment, with diverse group of people.
  • Proactive team player with problem solving mindset and excellent interpersonal skills
  • Proficient in Microsoft Office (Word, Excel, OneNote, PowerPoint, etc.), with aptitude to learn new software and systems
  • Experience in legal contract management is preferred.
  • Ability to multitask to follow up with parallel ongoing projects and good time management of various tasks assigned.

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