
Regulatory Project Manager
3 days ago
This role oversees planning and execution of regulatory projects from start to finish, ensuring timely completion and compliance with industry standards.
Main Responsibilities:
- Develop and create regulatory documents and product registration specifications for global markets.
- Manage operational tasks including regulatory assessments, training, PIP registrations, license management, and document control systems.
- Gather and compile technical and management reports for regulatory submissions.
- Analyze marketing and technical materials for regulatory compliance.
- Support due diligence on contracts and materials to safeguard intellectual property.
Requirements:
- Bachelor's degree in a scientific field (e.g., Biochemistry, Microbiology, Food Science, Pharmaceutical Science).
- Minimum 2 years of project management experience; PMP certification is an asset.
- Strong understanding of scientific data for regulatory purposes.
- Proficient in Microsoft Office; adaptable to new tools and systems.
Essential Skills:
- Project Management
- Regulatory Compliance
- Contract Management
- Intellectual Property
- Administrative Support
Avoidance of Regulatory Risks:
The ability to identify potential regulatory risks and implement effective mitigation strategies will be essential in this role. This includes staying up-to-date with changing regulations and maintaining open communication channels within the team and external partners.
Key Performance Indicators (KPIs):
- Timely completion of regulatory projects.
- Successful product registration in multiple markets.
- Effective management of regulatory documentation.
- Identification and mitigation of regulatory risks.
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