Regulatory Affairs

1 week 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._

  • Regulatory Affairs Specialist

    5 days ago

    Singapore Johnson & Johnson Full time

    The Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...

  • Regulatory Affairs Intern

    6 days ago

    Singapore GE HEALTHCARE Full time

    **Job Description Summary**: We are seeking a detail-oriented and motivated intern to support the Regulatory Affairs team with UDI (Unique Device Identification) data entry activities for Australia and Singapore. This role is ideal for students or recent graduates interested in regulatory affairs, data management, or the medical device industry. **Key...

  • Head of Regulatory Affairs

    5 days ago

    Singapore REGASK PTE. LTD. Full time

    **OUR COMPANY** We, at RegASK are a high growth global RegTech company leveraging technology and global network of experts to revolutionize regulatory intelligence, serving the LifeSciences (MedTech, CROs, Pharma) and FMCG industries (Food, Personal Care). RegASK team is highly diverse with more than 10 nationalities across 3 continents, entrepreneurial and...

  • Director Regulatory Affairs

    7 hours ago

    Singapore Planet Pharma Full time

    Director of Regulatory Affairs We’re partnering with a leading global clinical research organization (CRO) seeking an experienced Director of Regulatory Affairs to lead regional regulatory strategy and execution across APAC. This position offers the opportunity to represent the company’s regulatory strategy meetings, and Health Authority interactions –...

  • Regulatory Affairs Manager

    2 weeks ago

    Singapore DSM-Firmenich Full time

    COMPANY DESCRIPTION As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create...

  • Regulatory Affairs Specialist

    3 days ago

    Singapore Boston Scientific Corporation Full time

    **Work mode**:Hybrid**Onsite Location(s)**:Singapore, 01, SG**Summary** Ensures rapid and timely approvals for respective product line by plans on all product registrations, manage all product registrations' preparation and documentation. Interacts with regulatory agencies’ personnel in order to expedite approval of pending registration and answers any...

  • Regulatory Affairs Executive

    6 days ago

    Singapore FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD. Full time

    Full awareness of local Health Products and Medical Device Act and their regulations relevant to the business through regularly checking HSA websites and attending HSA briefings; - Communicate changes and new requirements to management; - Meet, discuss and negotiate with HSA regulators on matters pertaining to product registrations; - Have working knowledge...

  • Regulatory Affairs Intern

    2 weeks ago

    SGP--Singapore-Metropolis GE HealthCare Full time $30,000 - $50,000 per year

    Job Description SummaryWe are seeking a detail-oriented and motivated intern to support the Regulatory Affairs team with UDI (Unique Device Identification) data entry activities for Australia and Singapore. This role is ideal for students or recent graduates interested in regulatory affairs, data management, or the medical device industry.Job DescriptionKey...

  • Manager, Regulatory Affairs, Apac

    5 days ago

    Singapore Johnson & Johnson Full time

    **Job Function**: Regulatory Affairs Group **Job Sub**Function**: Regulatory Affairs **Job Category**: Professional **All Job Posting Locations**: Mongkok, Kowloon, Hong Kong, North Ryde, New South Wales, Australia, Petaling Jaya, Selangor, Malaysia, Seoul, Korea, Republic of, Singapore, Singapore, Taipei City, Taiwan Johnson & Johnson is seeking a...

  • Manager, Regulatory Affairs, Apac

    5 days ago

    Singapore Johnson & Johnson Full time

    **Job Function**: Regulatory Affairs Group **Job Sub Function**: Regulatory Affairs **Job Category**: Professional **All Job Posting Locations**: Mongkok, Kowloon, Hong Kong, North Ryde, New South Wales, Australia, Petaling Jaya, Selangor, Malaysia, Seoul, Korea, Republic of, Singapore, Singapore, Taipei City, Taiwan Johnson & Johnson is seeking a Manager,...