Quality and Regulatory Affairs Specialist

3 days ago

Central Region, Singapore Majeton Pte. Ltd. Full time $90,000 - $120,000 per year

At Majeton, weare driven by our commitment to deliver "The Right Product for Health". Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products.

We are seeking a meticulous and experienced Quality & Regulatory Affairs Specialist to join our team and ensure regulatory compliance, uphold product quality, and oversee vigilance reporting for all of our marketed products.

What you will do:

Quality Assurance (QA)

  • Handle and manage local annual GDPMDS and GDP inspection; support inspection readiness
  • Maintain and manage all controls of documents and records
  • Manage and maintain local GDPMDS and GDP SOP and system records, including but not limited to all product complaints, returns, disposal, internal inspection/ audit, deviation,CAPA management, etc
  • Manage new and existing supplier management activities
  • Perform personnel training to ensure regulatory and quality compliance

Regulatory Affairs & Pharmacovigilance (RA & PV)

  • Manage and process AE intake for all products
  • Perform signal detection
  • Manage compliance of all PV SOPs
  • Provide regulatory support in RA activities

You are someone who:

  • Holds a Bachelor's degree in Life Sciences, Pharmacy, or a related discipline
  • Has at least 2 years of experience in pharmaceutical or medical device QA or RA, with some exposure to PV
  • Is familiar with Singapore HSA regulations, including Health Supplements Guidelines, Medical Device Regulations, and GDP
  • Has experience in SOP writing, inspection preparation, and Quality Management Systems (QMS)
  • Demonstrates strong documentation, regulatory filing, and communication skills
  • Is eager to grow with the company and open to cross-functional learning and development
  • Is ready to take on more responsibilities within the Quality & Regulatory Affairs domain; training and mentorship provided
  • Is adaptable and willing to support the team with ad hoc tasks when required.

It's a bonus if you also have:

  • Knowledge or exposure to US FDA biologic regulations and pharmacovigilance systems
  • Experience in SME distribution companies or startup environments
  • Experience in preparing for inspection readiness

What we offer:

  • Competitive salary and performance-based bonuses
  • Opportunities for professional growth and development
  • Coffee treats from our generous bosses
  • A team of hard-working colleagues who work hard and play hard

  • Regulatory Affairs

    6 days ago

    Central Singapore Emprego SG Full time

    **Location** Singapore, Central Singapore **Job Type** Permanent **Salary** $5,000 - $10,000 Per Month **Date Posted** 6 minutes ago Additional Details **Job ID** 3010 **Job Views** 1 Roles & Responsibilities **Our client is a Consumer Health MNC, one of the leading players in the sector. Due to business needs, they are now recruiting multiple...

  • Regulatory Affairs Executive

    3 days ago

    Central Region, Singapore Poli Medical Company Pte Ltd Full time $90,000 - $120,000 per year

    Key Responsibilities:Regulatory Submissions & ApprovalsPrepare, compile, and submit product registration dossiers to HSA and other relevant regulatory authorities.Maintain up-to-date knowledge of Singapore's Health Sciences Authority (HSA) guidelines, ASEAN Common Technical Dossier (ACTD), and other regional requirements.Ensure timely approvals for new...

  • Regulatory Affairs Manager

    5 hours ago

    Central Singapore Reckitt Full time

    To provide regulatory affairs support and consultancy to internal and external stakeholders in a business‐oriented way. Liaise with a range of colleagues from marketing team, R&D, supply, and global/regional regulatory teams. Work closely with government agencies, external partners and contractors to ensure regulatory, safety and medical affairs issues...

  • Surveillance Regulatory Affairs Officer

    3 days ago

    Central Region, Singapore Marina Bay Sands Pte Ltd Full time $40,000 - $80,000 per year

    LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HEREBe part of our diverse and inclusive team.Job ResponsibilitiesGeneral ResponsibilitiesPerform surveillance monitoring or review required by the department to ensure sequence and details of events is comprehensively, accurately and objectively documentedPerform surveillance footage archival required by the...

  • Regulatory Affairs Manager

    3 days ago

    Central Region, Singapore ALLIED SEARCH PTE. LTD. Full time $104,000 - $130,878 per year

    Opportunities for professional developmentReputable organizationGood company benefitsAs an Regulatory Affairs Manager (Chinese Proprietary Medicine), you will be responsible for the following duties:Serve as the primary point of contact between the company and regulatory authorities (e.g., Health Sciences Authority) to oversee and support product...

  • Regulatory Affairs Executive

    2 weeks ago

    Central Singapore Emprego SG Full time

    **Location** - Singapore, Central Singapore**Job Type** - Permanent**Salary** - $4,000 - $7,000 Per Month**Date Posted** - 2 hours agoAdditional Details **Job ID** - 113486**Job Views** - 1Roles & Responsibilities **Our client is a Consumer Health MNC, one of the leading players in the sector. Due to business needs, they are now recruiting Regulatory...

  • Manager, Asean Regulatory Affairs

    4 days ago

    Central Singapore Reckitt Full time

    **_Responsibilities:_** - Participate in global / regional projects as regional regulatory point of contact to drive innovations and/or maintenance of Reckitt’s Nutrition portfolio for the ASEAN region - Works closely with global / country regulatory affliates to develop regulatory strategies to drive innovation or productivity work. - Provide regional...

  • Senior Flight Operations Support Specialist

    7 days ago

    Central Singapore BOEING Full time

    At Boeing, we innovate and collaborate to make the world a better place. We’re committed to fostering an environment for every teammate that’s welcoming, respectful and inclusive, with great opportunity for professional growth. Find your future with us. **Position Overview**: Boeing Flight and Training Services Singapore is looking for a **Senior Flight...

  • Regulatory Affairs Executive

    4 days ago

    Central Singapore Emprego SG Full time

    **Location** Singapore, Central Singapore **Job Type** Permanent **Salary** $3,000 - $3,500 Per Month **Date Posted** 37 minutes ago Additional Details **Job ID** 3437 **Job Views** 1 **Job Description**: Roles & Responsibilities If you have a passion for Regulatory Affairs within Medical Devices and ready to take a new step, get in touch as we...

  • Regulatory Affairs Project Manager

    7 days ago

    Central Singapore Emprego SG Full time

    **Location** Singapore, Central Singapore **Job Type** Permanent **Salary** $5,000 - $8,000 Per Month **Date Posted** 2 hours ago Additional Details **Job ID** 2604 **Job Views** 1 **Job Description**: Roles & Responsibilities **_ Key responsibilities:_** - To act as technical regulatory expert within the Regulatory team - To lead and execute...