Regulatory Affairs

7 days ago

Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

Singapore/Pharmaceutical Division

**Job Purpose**

To contribute as an integral member of Client’s Singapore RA team to support all regulatory activities for Client’s products. This includes the development and implementation of regulatory strategies, including the review, preparation of submissions, required to secure regulatory approval across various therapeutic areas, in alignment with core business objectives.

**Major Accountabilities**
- Prepares submission dossier for post-approval variations including safety label changes, on site transfers, CMC variations, GMP certification activities and any other CMC or administrative related activities within agreed timelines.
- Maintains knowledge of latest regulatory requirements for therapeutic products.
- Establish and maintain good working relationship with the HSA.
- Ensures new regulatory initiatives and changes are shared with the regional/global RA function in a timely manner with critical assessment of potential impact on business for the projects assigned.
- Perform variation assessments when requested by global RA Franchise teams.
- Management of Regulatory operations
- Develop and maintain regulatory database(s), files and records as required
- Ensures compliance with local regulations, corporate policies and procedures
- Investigate regulatory compliance gaps with gap remediation plan development and implementation thereafter.
- Prepares monthly project status updates
- Process CPP Applications as and when required.
- Support process improvements and implementation of best practices
- Collaboration with cross-functional teams and acts as primary RA contact for the local team for the projects assigned.
- Collaborates with local Quality Assurance (QA) on Quality matters (eg implementation of CMC and administrative changes)
- Reporting to RA Manager, Singapore

**Ideal Background**

**Education **(minimum/desirable):
BSc in health-related science, life science, Pharmacy degree desired

**Languages**:
English - fluent in speaking and writing.

**Experience**:
**Personal Attributes**:

- 1-2 years of experience in regulatory affairs or related work experience.
- Proven track record of preparing and reviewing regulatory documentation, and managing submissions successfully
- Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products
- Good understanding of local regulatory environment, guidelines, and processes for product registration.
- Good interpersonal, organizational, negotiation and problem-solving skills
- Excellent verbal and written communication skills
- Ability to work independently and in a team.
- Able to work within a multidisciplinary and multi-culturally team environment and independently as individual contributor.
- Able to share concepts, ideas, information and suggestions with peers.
- Able to provide regulatory inputs to other departments.
- Able to manage multiple assignments and tasks, within tight timelines.
- We regret that only shortlisted applicants will be notified._

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