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Regulatory Affairs Specialist
2 months ago
At PharmEng Technology PTE. LTD., we are seeking an experienced Regulatory Affairs Associate to join our team in Singapore. As a key member of our regulatory team, you will be responsible for ensuring compliance with local regulations, corporate policies, and procedures.
Key Responsibilities:
- Prepare and review regulatory documentation, including submissions and reports.
- Maintain knowledge of latest regulatory requirements for therapeutic products.
- Act as primary RA contact for local team for projects assigned.
- Ensure new regulatory initiatives and changes are shared with regional/global RA function in a timely manner.
- Investigate regulatory compliance gaps and develop remediation plans.
- Develop and maintain regulatory databases as required.
- Maintain and update regulatory files and records as required.
- Collaborate with local Quality Assurance (QA) on quality matters.
Requirements:
- Bachelor's degree in health-related science, life science, or pharmacy.
- 1-2 years of experience in regulatory affairs or related work experience.
- Proven track record of preparing and reviewing regulatory documentation.
- Good knowledge and understanding of pharmaceutical and scientific processes.
- Good understanding of local regulatory environment, guidelines, and processes for product registration.
Why PharmEng Technology?
We value our employees' unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel, and a team mentality that sets us apart from our competitors.
EEOC Statement:
We are proud to be an equal opportunity workplace and celebrate diversity in the workplace.