36 Product Registration jobs in Singapore
Product Registration Specialist
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We are seeking a seasoned professional to oversee the registration of our products in designated countries. This key role involves coordinating dossier preparation and certificate provision within specified timeframes.
The ideal candidate will serve as the primary point of contact between factories and regulatory teams, providing critical support for new product registrations and changes.
- Serve as liaison between factories and regulatory teams.
- Coordinate product registration processes.
- Ensure compliance with all relevant regulations.
This is an exciting opportunity for a motivated individual to join our organization and contribute to the success of our product registration initiatives.
RequirementsTo be considered for this position, applicants must possess:
- A degree in a relevant field such as business, law, or science.
- A minimum of 3 years of experience in a similar role.
We offer a dynamic and supportive work environment, opportunities for growth and development, and a competitive compensation package.
Product Registration Manager
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Job Opportunity: Senior Executive
- To manage product registrations and renewals in designated countries, ensuring timely delivery of necessary documents and certificates.
- Serve as the primary point of contact between factories and regulatory teams of assigned countries.
- Provide expert regulatory assessments for new products and changes to existing offerings.
- Offer guidance on interpreting relevant industry guidelines and standards to internal and external stakeholders.
- Support the preparation of tender submission documents.
Essential Qualifications:
- Relevant degree qualification.
- Minimum three years of experience in a related field.
Key Responsibilities Include:
- Product registration and renewal coordination.
- Regulatory team liaison services.
- Regulatory assessment provision.
- Guidance on industry standards and regulations.
- Tender submission support.
Senior Product Registration Specialist
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The role of Product Registration Coordinator involves coordinating product registration in designated countries, ensuring timely submission of documents for dossier preparation and certificates. This includes providing regulatory assessments for new products or change introductions.
As the point of contact between factories and regulatory teams, you will facilitate communication and provide guidance on interpreting relevant guidance documents and standards.
Additionally, you will support document preparation for tender submissions and perform other ad-hoc duties assigned by superiors.
- Relevant degree
- Minimum 3 years of relevant experience
- Proven ability to coordinate multiple tasks and projects simultaneously
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Knowledge of regulatory requirements and industry standards
This is an exciting opportunity to join our organization and contribute to the growth and success of our business. We offer a competitive salary and benefits package, as well as opportunities for professional development and career advancement.
OthersWe are committed to creating a diverse and inclusive work environment that values and respects all employees. If you are a motivated and organized individual who is passionate about product registration, we encourage you to apply for this role.
Director, Product Lifecycle Methodology
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Job ID: 38229
Location: Singapore, SG
Area of interest: Corporate & Commercial Banking
Job type: Regular Employee
Work style: Office Working
Opening date: 15 Sept 2025
JOB SUMMARY
Work together with the Product Lifecycle Methodology Lead for the preparation and roll out phase of a robust Product Lifecycle Methodology across the Cash Management Organisation at group, region and country level. This methodology is strategically vital for ensuring Product Managers are empowered with the clarity, collaboration, and capabilities needed to create value and drive impactful and measurable outcomes alongside a broad and diverse stakeholder community.
The role requires extensive collaboration with group-level, regional and in-country product managers to prepare and roll out the product life cycle methodology in a manner that ensures it is fully embedded in how product managers deliver in their roles. The ideal candidate will have previous product management expertise in a large global bank with hands on exposure to the delivery of a product across the entire life cycle. As the role entails creating and embedding a new, standardized way of working across the organization, prior experience in project management, training, organisational change management are plus points.
RESPONSIBILITIES
Strategy
- Collaborate with senior leaders across the bank to secure buy-in for the methodology across their functions.
- Drive planning and execution of the preparatory and roll out phase of the product lifecycle methodology (PLC).
- Determine and build the variety of cross functional partnerships needed to successfully embed the PLC.
- Put in place a digital first approach to ensure process and documentation are digitally available to relevant parties during the lifecycle.
- Manage the Consulting Partner relationship and deliverables.
- Advocate the development of new technologies and tools for the full spectrum of product groups and products.
Business
- Define clear measures of success that can demonstrate progress at each stage of the PLC.
- Establish a PLC that creates an enhanced commercial focus in the product management teams.
- Work with the Group Product Heads to establish a set of KPIs and OKRs that the product managers can consistently drive based on their respective work items.
- Drive greater commercial returns through better product and product manager performance management as well as Higher levels of ownership and accountability
- Improved product profitability
- Optimised pricing, marketing and distribution
- Improved product-market fit
- Accelerated speed to market creating longer windows to draw advantage from
- Early signalling of strategic intent to the market
Processes
- Establish clear standards to ensure quality deliverables across the lifecycle.
- Influence diverse stakeholders, overcome resistance to new processes, and effectively institutionalize these new methodologies.
- Manage Project budget and timelines as agreed.
- Implement ongoing checks and balances to measure performance as per the PLC methodology.
- Gain operational efficiencies and leverage through developing a skills-based organization.
- Accelerated speed-to-market with standard methodology
- Reduced time for approvals and gathering documentation
- Standardised product sets and reduction of underperforming and unprofitable product instances
- Reduced duplication in product development resource allocation
- Consistent service quality with alignment across channels, systems, processes and standard
- Improved cross functional alignment/collaboration across the business
- Excellent post-launch commercialisation readiness
- Post-launch operational and servicing readiness
People & Talent
- Lead through collaboration, influence, to drive.
- Lead through example and build the appropriate culture and values.
- Set appropriate tone and expectations amongst colleagues and work in collaboration with risk and control partners.
- Ensure active communication of vision, priorities, and progress to the business to foster engagement, awareness and motivation.
Risk Management
- Ensure the PLC has the required Risk and Awareness elements well embedded into the processes.
Governance
- Ensure the PLC meets all the prescribed Governance standards that the bank has established.
- Reduce internal controls (automated, preventative controls/ centralised data) and in product development rework or remediation
- Streamlining and simplifying approvals to manage risk more effectively
- Improved management visibility of portfolio, including active management and retirement of underperforming products
- Stronger risk mitigation and regulatory compliance aligned to product complexity
- Early identification of risk (commercial, operational, customer, regulatory)
- Improved audit readiness through standardised documentation and traceability
- Early PLC engagement with risk and governance functions/colleagues
Regulatory & Business Conduct
- Display exemplary conduct and live by the Group's Values and Code of Conduct.
- Take personal responsibility for embedding the highest standards of ethics, including regulatory and business conduct, across Standard Chartered Bank. This includes understanding and ensuring compliance with, in letter and spirit, all applicable laws, regulations, guidelines and the Group Code of Conduct.
- Lead to achieve the outcomes set out in the Bank's Conduct Principles
- Effectively and collaboratively identify, escalate, mitigate and resolve risk, conduct and compliance matters.
Key Stakeholders
External
- Consulting Partners
Internal
- Cash Product – Group, Region, Country
- Cash Product Risk
- Digital Channels
- CFCC
- Legal
- Operations Risk
- TB Sales
- Talent
- Learning
- TB COO
- TB Marketing
Our Ideal Candidate
- 5+ years of experience in Product Lifecycle Methodology either in a regional role or group vertical in a bank
- Strong stakeholder management skills both internal and external
- Proactive and positive with the ability to make good / sound decisions and use independent judgement.
- Interpersonal skills in networking, influencing and decision taking.
- Good presentation, time management, negotiation and influencing skills.
- Excellent written & oral communication skills
Role Specific Technical Competencies
- Knowledge of Product Line
- Emerging Technologies
- Planning: Tactical, Strategic
- Product Design and Development
- Product Development Life Cycle
- Marketing Strategy and Positioning
About Standard Chartered
We're an international bank, nimble enough to act, big enough for impact. For more than 170 years, we've worked to make a positive difference for our clients, communities, and each other. We question the status quo, love a challenge and enjoy finding new opportunities to grow and do better than before. If you're looking for a career with purpose and you want to work for a bank making a difference, we want to hear from you. You can count on us to celebrate your unique talents and we can't wait to see the talents you can bring us.
Our purpose, to drive commerce and prosperity through our unique diversity, together with our brand promise, to be here for good are achieved by how we each live our valued behaviours. When you work with us, you'll see how we value difference and advocate inclusion.
Together we:
- Do the right thing and are assertive, challenge one another, and live with integrity, while putting the client at the heart of what we do
- Never settle, continuously striving to improve and innovate, keeping things simple and learning from doing well, and not so well
- Are better together, we can be ourselves, be inclusive, see more good in others, and work collectively to build for the long term
What we offer
In line with our Fair Pay Charter, we offer a competitive salary and benefits to support your mental, physical, financial and social wellbeing.
- Core bank funding for retirement savings, medical and life insurance, with flexible and voluntary benefits available in some locations.
- Time-off including annual leave, parental/maternity (20 weeks), sabbatical (12 months maximum) and volunteering leave (3 days), along with minimum global standards for annual and public holiday, which is combined to 30 days minimum.
- Flexible working options based around home and office locations, with flexible working patterns.
- Proactive wellbeing support through Unmind, a market-leading digital wellbeing platform, development courses for resilience and other human skills, global Employee Assistance Programme, sick leave, mental health first-aiders and all sorts of self-help toolkits
- A continuous learning culture to support your growth, with opportunities to reskill and upskill and access to physical, virtual and digital learning.
- Being part of an inclusive and values driven organisation, one that embraces and celebrates our unique diversity, across our teams, business functions and geographies - everyone feels respected and can realise their full potential.
Recruitment Assessments
Some of our roles use assessments to help us understand how suitable you are for the role you've applied to. If you are invited to take an assessment, this is great news. It means your application has progressed to an important stage of our recruitment process.
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Regulatory Affairs
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Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.
Regulatory Affairs & QMS Manager.
Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:
Regulatory Affairs & Compliance:
- Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
- Interpret and apply global medical device regulations and standards.
- Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
- Maintain regulatory intelligence and proactively communicate changes to the organization.
- Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
- Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).
Quality Management System (QMS):
- Serve as the QMS Management Representative as required by ISO 13485.
- Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
- Lead internal audits, management reviews, and risk management activities.
- Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
- Monitor and report on QMS performance metrics and key quality indicators (KPIs).
- Ensure proper document control and change management processes are implemented.
- Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.
About the company:
- American startup with senior management team; based in US, Europe and Singapore
- Hybrid work arrangement – 2 days in office, 3 days working from home
- Excellent medical insurance coverage
- Good variable bonus structure
- Great working culture
- Excellent office location (Central – just beside MRT)
Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.
You can also contact Vincent Low for a confidential discussion at
EA Personnel Registration No: R
regulatory affairs manager
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- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Oversee documentation efforts to ensure compliance with local and international regulations and standards. Develop and maintain standard operating procedures.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Review materials such as marketing literature or user manuals to ensure that regulatory requirements are met.
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Participate in the development or implementation of clinical trial products.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory authorities.
- Provide responses to regulatory authority regarding product information or issues.
- Review all regulatory authorities' submission materials to ensure timeliness and accuracy.
- Communicate regulatory information to relevant departments and ensure that information is interpreted correctly.
Regulatory Affairs Executive
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Job Responsibilities
- Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
- Be the subject matter expert on medical devices laws and regulations for product registration in company's regions of interest.
- Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process.
- Involve in the process of product testing, clinical verification, data collection and relevant tracking.
- Submit to agencies scientific special projects on behalf of the company.
- Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
- Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
- Any other ad-hoc duties or projects as required by the management team.
- A bachelor's degree in in Life Sciences, Pharmacy, or a related field
- Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices.
- Expert in medical device product registration laws and regulations, able to independently draft registration dossier.
- You shall have complete registration experience of Class B, C and D medical devices.
- Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
- Familiar with IVD product development and commercialization life cycle.
- Systematically project management, good planning, execution and timely communication. Good presentation skills.
- Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
- Meticulous and strong sense of responsibility; able to handle stress and tight schedule.
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Regulatory Affairs Pharmacist
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A great opportunity to be part of a dynamic and progressive mid-size SME healthcare provider with a regional presence, as MD Pharmaceuticals Pte Ltd continues on its growth and expansion plans in Singapore, Malaysia, Hong Kong, Thailand, Myanmar and other parts of Asia in the coming years.
MD Pharmaceuticals Pte Ltd is now seeking to hire:
- Regulatory Affairs Pharmacist & Products Specialist (Pharmaceuticals products)
Unlike regular one-dimensional Pharmacist roles, the above position will enable the successful candidates to have more exposure to the related fields of Regulatory Affairs, Sales/Marketing & Business Development in the pharmaceutical industry.
The role is also based locally. However, there will be opportunities for overseas exposure and career advancement if the individual can prove himself /herself through solid work performance.
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Main responsibilities:
- Assist with regulatory affairs and compliance work for the company's operations in Singapore and the Asian region, including dealing with product suppliers and regulatory bodies like HSA
- Actively stay updated and provide guidance on clinical information related to the company's suite of products, comprising both therapeutic drugs and healthcare supplements
- Drive the sales and marketing efforts of our products by gathering market/competitor information & proposing creative and feasible ideas as well as content to grow the sales and market share of our existing products
- Suggest and look into bringing in new potential products based on up-to-date market research and strong clinical evidence
- Gain a holistic understanding of the medical industry through practical sales and marketing outreach to develop the company's existing client base
- Establish sincere and professional relationships with healthcare professionals as well as key opinion leaders in the healthcare industry
- Assist with product trainings and provide related support to the Sales team
- Handle other duties as assigned
Key requirements:
- Must have at least a Bachelor's Degree in Pharmacy/Pharmacology, with a valid Pharmacist License registered under the Singapore Pharmacy Council
- Practical experience in the healthcare industry, including interaction with patients and healthcare professionals, would be beneficial
- Interested in Sales & Marketing/Business Development with an ability to apply clinical knowledge to better achieve sales and marketing outcomes
- Ability to work independently as well as in a team, including across different cultures and functions
- Solid communication skills, especially in both written and oral English. Working language proficiency in Mandarin/Thai would be an additional advantage for work-related translation purposes.
- Strong interpersonal skills, including ability to convince key stakeholders
- Positive, results-driven with a responsible attitude. Having own initiative is important for this role.
- Any Graphics Design skills, together with the knowledge of softwares such as Adobe Illustrator and Photoshop, etc. would be an advantage.
Interested candidates, please submit your updated resume & expected salary to us through the "Apply Now" button.
Specialist, Regulatory Affairs
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About ResMed
At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and patient trust are at the heart of our innovation.
Regulatory Affairs (RA) at ResMed is central to ensuring timely and compliant access to global markets. We work across more than 140 countries to deliver safe and effective innovations that improve quality of life. With global reach, deep technical knowledge, and strong regulatory partnerships, we lead with integrity and clarity to shape the future of health technology.
Team Overview
Regulatory Product Strategy & Delivery (RPSD) (Singapore).
The Singapore RPSD team leads regulatory strategy and delivery for products where ResMed Singapore is the legal manufacturer. The team supports New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) projects, enabling global submission readiness, risk assessments, and regional collaboration.
As an individual contributor in this team, the Specialist, Regulatory Product Strategy & Delivery – Singapore will partner with cross-functional stakeholders to ensure design, documentation, and change activities meet regulatory expectations across all key markets (e.g., US, EU, APAC, LATAM)
Position Summary
As a Specialist, Regulatory Product Strategy & Delivery – Singapore, you will contribute directly to the successful delivery of regulatory strategy, submission documentation, and change management activities for Singapore-manufactured devices and accessories.
You will represent Regulatory Affairs on cross-functional teams and collaborate with global RA colleagues to ensure alignment, accuracy, and traceability across submissions and product lifecycle updates. This is a critical role in ensuring regulatory quality, efficiency, and global market continuity.
Key Responsibilities
1. Regulatory Strategy & Execution
- Support regulatory strategy development and documentation for NPI and PLE projects led by the Singapore RPSD team.
- Participate in the preparation, review, and submission of global regulatory filings including 510(k), CE MDR, TGA, Health Canada, and regional registrations.
- Contribute to authoring of submission content such as labelling justifications, equivalence arguments, standards declarations, and technical summaries.
2. Product Change Support
- Evaluate the regulatory impact of product and design changes via DCA/CPA frameworks, contributing to global significance assessments and risk mitigation actions.
- Review and update technical file documentation, declarations, and certificates in collaboration with the Regulatory Foundations team.
- Track submission timelines and deliverables using Jira and other RA platforms.
3. Cross-Functional Collaboration
- Represent Regulatory Affairs in cross-functional project teams involving engineering, clinical, quality, labelling, and supply chain.
- Participate in design reviews, change assessments, and internal risk forums as the RA contributor for Singapore-based products.
- Collaborate with Regional RA and global RPSD counterparts to ensure harmonization of documentation and submission approaches.
4. Regulatory Systems & Process Improvement
- Maintain accurate regulatory records and document control through RIMSYS, Confluence, and SharePoint tools.
- Support continuous improvement activities by contributing to template updates, process harmonization, and RA onboarding content.
- Assist in audit readiness activities and postmarket traceability tasks as needed.
5. Other Duties and Requirements
- Perform additional responsibilities as required to support RA and RPSD objectives.
- Contribute to process improvements and special projects across Regulatory Affairs.
- Support inspections, audits, and team collaboration activities.
Qualifications & Experience
Required
- Bachelor's degree in engineering, life sciences, health policy, or a related field.
- 3+ years of experience in Regulatory Affairs or a compliance-related role within a regulated industry (preferably medical devices).
- Familiarity with product development under design control and regulatory frameworks (e.g., ISO 13485, ISO 14971, 21 CFR 820).
- Strong communication, organization, and document review skills.
- Ability to manage multiple priorities, meet deadlines, and operate effectively in a cross-functional team environment.
Preferred
- Experience preparing or contributing to global regulatory submissions (e.g., FDA 510(k), EU MDR, TGA).
- Understanding of Singapore-specific regulatory frameworks and product license processes.
- Familiarity with submission and documentation tools such as Jira, RIMSYS, and Confluence.
- Experience supporting Class II or III medical devices in respiratory or digital health fields.
Who You Are
You are a regulatory problem-solver and proactive collaborator. You bring technical curiosity and process discipline to your work, with a sharp eye for detail and a strong sense of responsibility for quality. Whether it's preparing documentation, clarifying regulatory pathways, or contributing to design decisions—you show up with clarity, consistency, and a drive to improve.
Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now
Regulatory Affairs Intern
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Job Description
Job Scope:
- Cosmetic Notification
- Documentation preparation: Assist in collecting, organizing product information and technical documents required for cosmetic notification.
- Regulatory submission: Support the submission of cosmetic product notifications to relevant regulatory authorities or online portals. Track and update submission status and follow up on pending applications.
- Database Management
- Maintain and update internal databases or trackers for product notifications, approvals, and related correspondence.
- Support Regulatory Compliance Checks
- Conduct first-line marketing claims review in accordance with the acceptable/prohibited claim list published by the authority.
- Cross-functional Coordination
- Liaise with Brand to gather required information related to product notification and marketing claim review.
Qualifications
- Undergraduate or recent graduate in Pharmacy, Chemistry, Life Sciences, or related field.
- Able to commit full time internship from Oct 2025 to Mar 2026
- Detail-oriented, organized, and able to manage multiple tasks.
- Proficient in Excel.
- Good communication skills (written and verbal).