Current jobs related to Regulatory Specialist/Senior Regulatory Specialist, Audit Branch - Singapore - Health Sciences Authority

  • Regulatory Compliance

    3 weeks ago

    Singapore Woori Bank Full time

    Regulatory Compliance (Specialist/Senior Specialist) As part of the Regulatory Compliance Team, the hired candidate is expected to perform the following duties, and not limited to: Regulatory Liaison and Stakeholder Management Assist the Regulatory Compliance Manager in liaising with regulatory authorities and government agencies (eg. MAS/ABS/ACRA etc.) ...

  • Regulatory Affairs Senior Specialist

    2 weeks ago

    Singapore CooperSurgical Full time

    CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the...

  • Senior/Regulatory Specialist, Complementary Health Products Branch

    3 days ago

    Singapore HSA Health Sciences Authority Full time

    (What the role is) The Senior/Regulatory Specialist of the Complementary Health Products Branch will plan, coordinate and implement policies and standards to ensure the safety and quality of complementary health products in Singapore. (What you will be working on) Perform safety and quality evaluation of complementary health products (CHPs) and...

  • Senior Specialist, Internal Audit

    2 days ago

    Singapore BTI EXECUTIVE SEARCH PTE. LTD. Full time

    Our client in corporate banking is hiring a professional in internal audit to join their team. **Senior Specialist, Self-Assessment The Senior Specialist, Self-Assessment is expected to provide support to Head of Self-Assessment in executing self-assessment / ad-hoc reviews and coordination work with relevant stakeholders. **Responsibilities**: - Perform...

  • Regulatory Affairs Specialist, Chemicals

    2 days ago

    Central Singapore Emprego SG Full time

    **Location** - Singapore, Central Singapore**Job Type** - Full Time**Salary** - $3,500 - $5,500 Per Month**Date Posted** - 1 hour agoAdditional Details **Job ID** - 103882**Job Views** - 1Roles & Responsibilities **Job Title: Regulatory Affairs Specialist, Chemicals** **Reports to: Sr Manager, Business Process Excellence** **Location: Marsiling,...

  • Regulatory Compliance Specialist

    1 week ago

    Singapore beBeeCompliance Full time $80,000 - $120,000

    Job Description:Regulatory Compliance SpecialistWe are seeking a skilled Regulatory Compliance Specialist to join our team. The ideal candidate will have a strong background in accounting and financial reporting standards, as well as excellent analytical skills.About the Role:Improve corporate reporting and support compliance with regulatory requirements and...

  • Regulatory Compliance Specialist

    2 weeks ago

    Singapore NETS Full time

    Join or sign in to find your next job Join to apply for the Regulatory Compliance Specialist role at NETS 2 days ago Be among the first 25 applicants Join to apply for the Regulatory Compliance Specialist role at NETS This role is responsible for ensuring the company's adherence to all related and relevant compliance regulations. He/She will be the...

  • Regulatory Compliance Specialist

    2 weeks ago

    Singapore beBeeCompliance Full time

    Regulatory Compliance Specialist Job Summary This is a key leadership position that oversees the development and implementation of our company's regulatory compliance framework. Job Description: The Regulatory Compliance Specialist will be responsible for ensuring our company's adherence to all applicable laws, regulations, and industry standards....

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore beBeeRegulatory Full time

    Regulatory Affairs Specialist Job Description This is a comprehensive overview of the key responsibilities and deliverables for the Regulatory Affairs Specialist role.

  • Regulatory Compliance Specialist

    2 weeks ago

    Singapore beBeeCompliance Full time

    Job Title: Regulatory Compliance Specialist We are seeking a highly skilled and detail-oriented Regulatory Compliance Specialist to join our team. Key Responsibilities: Ensure adherence to regulatory guidelines for client onboarding and data maintenance. Collaborate with stakeholders to review complex

Regulatory Specialist/Senior Regulatory Specialist, Audit Branch

2 weeks ago

Singapore Health Sciences Authority Full time $80,000 - $120,000 per year

What the role is

[What the role is]
This position serves to support the Audits Branch (AB) in implementing the regulatory inspection and licensing regime, policies and initiatives governing the
full spectrum of dealers across various health product categories in Singapore so as to meet HSA's national objective of ensuring that these health products meet the required standards of quality, safety and efficacy to safeguard public health and safety.

What you will be working on

[What you will be working on]

i) Lead the conduct or conduct of local/overseas regulatory inspections and licensing of manufacturers and dealers of health products and pharmacies ensuring that they conform to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), regulatory requirements and other relevant quality system standards.
ii) Lead/assist in the review of regulatory policies and legislations related to manufacturers and dealers of health products and active ingredients and the translation into specific technical and operational plans for implementation to achieve the desired outcome.
iii) Lead/assist in the review, development and implementation of technical standards, industry guidelines, internal good practice guidance on GMP inspections
iv) Lead/assist the effective implementation of the AB's Quality Management System (QMS) in accordance with Phamaceutical Inspection Co-operation Scheme (PIC/S), ISO 9001 standard and other international standards, e.g., WHO ML4 & WLA.
v) Lead in/assist in the management and handling of stakeholders' technical and procedural enquiries.
vi) Lead in/assist with performing assessment of changes (URS, UAT, etc.) to electronic processing systems for inspection and licensing.
vii) Lead/assist in the inspection scheduling and monitoring of performance indicators related to inspections.
viii) Assist the Branch Director and Unit Deputy Director in ensuring that there are effective mechanisms in place to capture, store and communicate key information, experience and knowledge gained by the inspection teams.
ix) Work in collaboration with international colleagues to facilitate technical liaison with other regulatory authorities and relevant bodies in the field of GMP inspection.
x) Perform such other duties as the department may reasonably require.

What we are looking for


• Possess knowledge/experience in pharmacy, life sciences, pharmacology, chemistry, chemical engineering, biochemistry, biotechnology, microbiology, genetic or tissue engineering.


• Preferably with 2-5 or more years of experience in manufacturing and/or quality assurance/control in the pharmaceutical/biopharmaceutical industry, with good understanding in the sterile manufacture and aseptic processing of pharmaceutcal products.


• Good understanding in the current international regulatory landscape and developments in the field of manufacture of biopharmaceutical or cell, tissue and gene therapy products.


• Passion for GMP inspection work with good knowledge and experience in international GMP standards (e.g., PIC/S GMP).


• Familiar with the use of computer softwares including word and data processing applications.


• Communicates both orally and in writing effectively.


• Ability to work as part of a multidisciplinary team.


• Ability to travel for overseas inspection work assignments.


• Candidate with no prior work experience are welcome to apply

[What we are looking for]