Regulatory Affairs Executive

2 days ago

Singapore Reeracoen Singapore Pte Ltd Full time

Our Client is a pharmaceutical Company from Japan. The role of a Regulatory Affairs Executive is to responsible for ensuring the safety and efficacy of our existing and pipeline products to produce safe, effective.
You will be reporting to PV/RA/QM Manager.
【 What you will be doing 】
- Maintains current knowledge, ensures compliance, and communicates with the relevant global, regional, and local functions of the local regulatory requirements.
- Review, process, and forward safety events (pre-marketing and post-marketing) and/or other medically related information to Global PV and submits such safety events to the local health authority according to relevant global/local SOPs and local requirements.
- Perform a review of abstracts and full articles to identify safety information from literature sources.
- Support creation, management, and oversight of local RMP and all RMP-related PV activities.
- Support the creation and management of local PSMF development.
- Liaise with the investigational site and reporter as necessary regarding safety issues.
- Develop local PV training material and conduct PV training as per relevant SOPs.
- Prepare, review, update and maintain PV clauses in all relevant agreements from a PV perspective.
- Manages and conducts oversight of Aggregate Report submission to the applicable local health authorities.
- Perform reconciliation of safety information with relevant internal and external functions.
- Supports audits and inspections, including external vendors, and ensures execution of deviation and CAPA management.
- Develop and maintain PV Business Continuity Plan in accordance with global SOPs
- Preparing registration dossiers to achieve timely regulatory approvals and maintenance of the existing licenses in the local market
- Reviewing change requests and assessing the regulatory impact of product changes
- Reviewing proposed labeling for compliance with product branding, global/regional standards, and applicable regulations
- Prepare, maintain, and supervise implementation, including training on current applicable local, regional, and global SOPs to ensure compliance in the company as required.
- Responsible for local operational quality matters including product hold and product recalls
- Support in addressing deviations, and product complaints from customer to manufacturer, monitor the status until the closure
- Manage outsourced activities to ensure vendors meet the applicable local and global standards
- ** Requirement**:
【 What they are looking for 】
- Bachelor’s Degree in Pharmacy, Life Sciences or equivalent with 1 - 3 years experience in PV and/or RA experience in Singapore Pharma Industry. Singapore licensed Pharmacist preferred.
- Strong organizational and process management skills.
- Able to multi-task effectively.
- Ability to manage relations with internal and external stakeholders
- Teamwork and collaboration with cross-functional teams
- ** Working Hour**: 9:00 ~ 18:00
- ** Benefit**:

- 【 What they are offering 】
- AWS
- Variable Bonus (Depend on Company and Individual performance)
- Annual Leave 15 days (Maximum up to 30 days)
- Medical Leave
- Medical Benefit
- Flex benefit (S$1500/year)

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