Regulatory Affairs Specialist

2 weeks ago


Tuas, Singapore Superform Consulting Pte Ltd Full time

Job Title: Regulatory Affairs Specialist
Location: Tuas
Working Days: Mon -Fri
Working Hours: 7.45 AM-4.45 PM

**Salary**: Basic up to $4000

Job Duties
- Prepare and maintain the registry of all products registered locally and internationally.
- Prepare and maintain the market's regulatory requirements for implementation in the company.
- Follow-up on any pre-market information and data required for dossier submission to the market-authorized representative for new product registration.
- Assist in data collection from market authorized representatives for post-market surveillance.
- Update the relevant standards, regulatory guidelines, and essential requirements.
- Support in any product recall activities in the markets as required.
- Liaise with regulatory authorities on factory inspection and work on inspection preparation.
- Preparation of Post Market Surveillance, Declaration of Conformance, Essential Requirement, Vigilance, Adverse Event Reporting, MDR certification.
- Participate in the internal and external quality audits, and inspections.
- Work with sales and marketing, and QA on label requirements.
- Communicate any changes in market regulatory requirements to all relevant functions with an action plan and timeline for implementation.

Job Requirements
- Diploma/Degree in Life Science (Pharmacy, Biology, Chemistry, Pharmaceutical).
- In-depth knowledge of the cGMP, market regulations (HSA, FDA, TGA, CFDA, EU), and ISO 13485.
- Understanding of law, regulation, and pending regulation.
- Good communication, technical writing, and interpersonal skills.

WONG MENG KANG

Superform Consulting Pte Ltd

License No.: R1988500/15C7536

**Salary**: $3,500.00 - $4,000.00 per month

Schedule:

- Monday to Friday

Supplemental pay types:

- Yearly bonus

**Education**:

- Local Polytechnic Diploma (preferred)


  • Regulatory Manager

    4 days ago


    Tuas, Singapore Element Solutions Inc Full time

    **Business Overview**: Element Solutions Inc. (NYSE: ESI) is a leading specialty chemicals company whose operating businesses formulate a broad range of solutions that enhance the performance of products people use every day. Developed in multi-step technological processes, our innovative solutions enable our customers' manufacturing processes in several key...

  • Senior QA Specialist

    15 hours ago


    Tuas, Singapore Pfizer Full time

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

  • Specialist 1, QA

    2 weeks ago


    Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their...

  • Specialist 3, QA

    2 days ago


    Tuas, Singapore Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • QA Specialist

    2 weeks ago


    Tuas, Singapore Pfizer Full time

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...


  • Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their...


  • Tuas, Singapore Novartis Full time

    **Summary**: Job Description Summary This role support/provide quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are driven in alignment to site...


  • Tuas, Singapore Randstad – Lonza Full time $60,000 - $120,000 per year

    Job Description:As a Specialist, QA (CGT) at Lonza, you will support day-to-day Quality Assurance activities in accordance with approved SOPs and policies for a multi-product, cGxP contract manufacturing facility. You will play a key role in providing QA oversight for operations, compliance, and documentation, ensuring that products meet the highest quality...

  • Equipment Specialist

    2 weeks ago


    Tuas, Singapore RESMED ASIA PTE. LTD. Full time $4,000 - $6,000 per year

    Job Description SummaryThe primary role of Production & Assembly function is to manufacture, assemble and pack products. Key deliverables include, managing the day-to-day production & planning functions for manufacturing whilst supporting changing demands. Programming, set-up, and monitoring of the production equipment/processes and performing assembly...

  • Specialist 2/3, QA

    1 week ago


    Tuas, Singapore Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...