Regulatory Affairs

1 week ago


Singapore Kemin Full time

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**:

- 3-6 years of project management experience
- Ability to understand advanced scientific data and information in order to generate dossiers for regulatory submission.
- Self-motivated 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 fast-paced multi-disciplinary environment, with diverse group of people.
- Pro-active 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 multi-task to follow up with parallel on-going projects and good time management of various tasks assigned.



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