Job Opportunities in Singapore
September 18, 2024
Artixio Consulting Pvt Ltd
FULL TIME
Regulatory Affairs Manager
This is a full-time hybrid role as a Regulatory Affairs Manager at Artixio. The Regulatory Affairs Manager will be responsible for ensuring regulatory compliance, managing regulatory requirements, overseeing regulatory submissions, and maintaining quality systems. The role is based in Singapore but allows for some remote work.
Qualifications
Pay: $4,000.00 - $10,000.00 per month
Experience:
Expected Start Date: 25/09/2024
Qualifications
- Minimum 10 years of experience managing complex pharmaceutical, biotech products portfolio
- Significant experience in meeting HSA requirements
- Experience in preparing, meeting, negotiation and maintaining communication with HSA
- Ability to lead the portfolio and guide international teams for successful maintenance of liceses in the country
- Ability to navigate complex regulations and advice global team
- Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs skills
- Experience in managing regulatory submissions and maintaining quality systems
- Knowledge of regulatory standards and requirements
- Update current regulations and changes to ensure ongoing compliance
- Review artwork and labeling
- Respond to safety related questions to HSA
- Experience in working with IT systems
- Strong project management skills
- Strong attention to detail and organizational skills
- Excellent communication and interpersonal skills
- Ability to work independently and in a team
- Bachelor's degree in a related field (e.g., Life Sciences, Regulatory Affairs)
- Relevant certifications (e.g., RAC) are a plus
- Experience with medical devices is a plus
- Ability to work from office 2-3 days a week
Pay: $4,000.00 - $10,000.00 per month
Experience:
- Regulatory Affairs: 10 years (Required)
Expected Start Date: 25/09/2024
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