711 Regulatory Positions jobs in Singapore

• Salary Range MYR 7,000 - 7,999
• City Bandar Sri Damansara
• Country Malaysia

• Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.
  
• Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).
  
• Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements.
  
• Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
  
• Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
  
• Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
  
• Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies.
  
• Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements.
  
• Ensure compliance with advertisement and labeling regulations in each marketing territory.
  
• Oversee and supervise compliance with other regulatory requirements from authorities such as MOH (MY), HSA (SG), NEA (SG), IMDA (MY/SG), DVS (MY/SG), and AVS (MY/SG).
  
• Plan and lead the implementation of internal RA audits on an annual basis.
  
• Support external audits conducted by regulatory agencies, principals, and suppliers by providing regulatory input to minimize the risk of non-compliance findings.
  
• Provide regulatory support during internal audits of subsidiaries and associated companies across Southeast Asia.
  
• Collaborate with Conformity Assessment Bodies on product risk assessment and regulatory implementation changes.
  
• Support regulatory matters related to custom import requirements and documentation.
  
• Assist and oversee matters involving licensed pharmacists or qualified personnel, including Poison A License and inspections by the Ministry of Health.
  

• Possess a Bachelor’s Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.
  
• Proficient in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
  
• Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training.
  
• Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers,effectively.
  
• In-depth knowledge and hands-on experience in medical device registration and regulatory compliance, particularly in Malaysia, Singapore, and Indonesia.
  
• Solid understanding of quality management systems, specifically ISO 13485, ISO 9001, and GDPMD requirements.
  
• Basic biomedical knowledge with the ability to understand and interpret technical aspects of medical devices.
  
• Strong understanding of operational workflows, with the ability to identify inefficiencies and implement process improvements.
  
• Meticulous and detail-oriented, capable of working independently with minimal supervision.
  
• Possess strong analytical and presentation skills, with the ability to translate data into meaningful insights.
  
• Proactive, performance-driven, and results-oriented, with a strong sense of ethical integrity and accountability in project execution.
  
• Pharmacist background with a valid license will be an added advantage.
  

• 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.

• Opportunities for professional development
• Reputable organization
• Good company benefits

As 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 registration, certification, and application processes for market entry. Ensure ongoing license maintenance (e.g., Marketing Authorizations) aligns with local regulatory requirements and that corporate regulatory systems, SOPs, and procedures are effectively implemented.
• Compile and organize technical documentation, product details, and ensure all materials related to product registration, manufacturing, and marketing adhere to Singapore's regulatory standards.
• Build and maintain strong working relationships with key external regulatory agencies; coordinate and attend meetings, and engage in regulatory negotiations as needed.
• Manage and ensure regulatory compliance for pharmaceutical exports from China to Singapore in accordance with relevant export regulations.
• Support internal teams by conducting research and evaluation of proprietary Chinese medicine formulas, and provide regulatory insights and consultation.

Requirements:

• Master's degree or above in Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, or a related field.
• At least 5 years of working experience is required, with 2 years of drug registration experience.
• Preferably a registered pharmacist with the Singapore Pharmacy Council, would be advantageous. Proprietary Chinese medicines is preferred.
• Proven ability to manage regulatory issues.
• Knowledge of regulatory environment and how this impacts regulatory strategy and implementation.
• Knowledge of drug development practice, rules, regulations and guidelines.

To apply, simply click on the "apply" button in the job advertisement or alternatively, you can send in your resume via email: .COM.SG

We regret to inform that only shortlisted candidates will be notified.

ALLIED SEARCH PTE. LTD.

EA LICENSE : 19C9777

Salary Range MYR 7,000 - 7,999
City Bandar Sri Damansara
Country Malaysia
Job Description
Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.
Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).
Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements.
Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies.
Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements.
Ensure compliance with advertisement and labeling regulations in each marketing territory.
Oversee and supervise compliance with other regulatory requirements from authorities such as MOH (MY), HSA (SG), NEA (SG), IMDA (MY/SG), DVS (MY/SG), and AVS (MY/SG).
Plan and lead the implementation of internal RA audits on an annual basis.
Support external audits conducted by regulatory agencies, principals, and suppliers by providing regulatory input to minimize the risk of non-compliance findings.
Provide regulatory support during internal audits of subsidiaries and associated companies across Southeast Asia.
Collaborate with Conformity Assessment Bodies on product risk assessment and regulatory implementation changes.
Support regulatory matters related to custom import requirements and documentation.
Assist and oversee matters involving licensed pharmacists or qualified personnel, including Poison A License and inspections by the Ministry of Health.
Requirements
Possess a Bachelor’s Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.
Proficient in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training.
Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers,effectively.
In-depth knowledge and hands-on experience in medical device registration and regulatory compliance, particularly in Malaysia, Singapore, and Indonesia.
Solid understanding of quality management systems, specifically ISO 13485, ISO 9001, and GDPMD requirements.
Basic biomedical knowledge with the ability to understand and interpret technical aspects of medical devices.
Strong understanding of operational workflows, with the ability to identify inefficiencies and implement process improvements.
Meticulous and detail-oriented, capable of working independently with minimal supervision.
Possess strong analytical and presentation skills, with the ability to translate data into meaningful insights.
Proactive, performance-driven, and results-oriented, with a strong sense of ethical integrity and accountability in project execution.
Pharmacist background with a valid license will be an added advantage.
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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.
#J-18808-Ljbffr

• 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.

Job Responsibilities:

·    Timely Submission and Accuracy of MAS Regulatory Reports

-   Prepare MAS regulatory reports and ensure reports are submitted within required time frame.

-   Ensure reports are complied with MAS requirements.

· Monitor the Bank's ratio including but not limited to LCR, MCB, AMR, DI etc. and ensure they are at least kept to meet MAS requirement.

· Review and understand MAS's regulation on definitions and context of the reports to ensure definitions and context are met within reports. Interpret/analyze impact on new/revised MAS notices or regulation.

· Liaise with other departments on reporting/data quality issues and provide suggestions continuous system/process enhancement and additional internal control to improve data quality.

· Liaise with other departments in providing regulatory compliance related information and guidance to meet the desired purpose.

· Liaise with external auditors in meeting statutory requirements.

· Plan, develop and implement accounting process under International Accounting Standard, Head Office Accounting Guidelines, statutory requirement, Internal Accounting Polices and Work Procedures.

· Carry out various ad hoc projects and request from MAS, Head Office, Management and other departments.

Job Requirements:

· A recognized University Degree, preferably in, Accounting, Finance, Analytics, Statistics, Mathematics, IT or programing related fields.

· More than 5 years relevant experience, preferably with working experience in banking and financial services industry, experience in working with accounting and regulatory reporting.

· Self-driven, a team player, good coordination and IT skills are preferred.

·    Possess good communication and interpersonal skills, strong analytical and problem solving skill, proficiency in the use of MS Excel/Word/PowerPoint /Access

Job Responsibilities:

• Timely Submission and Accuracy of MAS Regulatory Reports

• Prepare MAS regulatory reports and ensure reports are submitted within required time frame.

• Ensure reports are complied with MAS requirements.

• Monitor the Bank's ratio including but not limited to LCR, MCB, AMR, DI etc. and ensure they are at least kept to meet MAS requirement.

• Review and understand MAS's regulation on definitions and context of the reports to ensure definitions and context are met within reports. Interpret/analyze impact on new/revised MAS notices or regulation.

• Liaise with other departments on reporting/data quality issues and provide suggestions continuous system/process enhancement and additional internal control to improve data quality.

• Liaise with other departments in providing regulatory compliance related information and guidance to meet the desired purpose.

• Liaise with external auditors in meeting statutory requirements.

• Plan, develop and implement accounting process under International Accounting Standard, Head Office Accounting Guidelines, statutory requirement, Internal Accounting Polices and Work Procedures.

• Carry out various ad hoc projects and request from MAS, Head Office, Management and other departments.

Job Requirements:

• A recognized University Degree, preferably in, Accounting, Finance, Analytics, Statistics, Mathematics, IT or programing related fields.

• More than 5 years relevant experience, preferably with working experience in banking and financial services industry, experience in working with accounting and regulatory reporting.

• Self-driven, a team player, good coordination and IT skills are preferred.

• Possess good communication and interpersonal skills, strong analytical and problem solving skill, proficiency in the use of MS Excel/Word/PowerPoint /Access.

Regulatory Compliance Manager
Remote: Singapore
About Revolut
People deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products — including spending, saving, investing, exchanging, travelling, and more — help our 65+ million customers get more from their money every day.
As we continue our lightning-fast growth, 2 things are essential to our success: our people and our culture. In recognition of our outstanding employee experience, we've been certified as a Great Place to Work. So far, we have 10,000+ people working around the world, from our offices and remotely, to help us achieve our mission. And we're looking for more brilliant people. People who love building great products, redefining success, and turning the complexity of a chaotic world into the simplicity of a beautiful solution.
About the role
Our Compliance team blends regulatory expertise with data-driven thinking to make sure our products meet legal and policy requirements and deliver real value to customers. In a fast-moving, digital environment, they stay one step ahead by finding smart, scalable ways to manage conduct risk.
We’re looking for a Regulatory Compliance Manager who can see what’s needed to keep our consumer protection practice in compliance. You'll be responsible for advising our business on compliance requirements and related controls.
Up to shape what's next in finance? Let’s get in touch.
What you'll be doing
Advising the business on compliance requirements and related controls regarding manufacturer and principal responsibilities
Reading large pieces of regulation and breaking down what needs to be done and how it applies to the business model
Liaising with regulatory bodies on inspections and day-to-day queries
Identifying, assessing, monitoring, and reporting on compliance risks in a MiFID II investment firm, including MAR and Personal Account Dealing
Developing and implementing the compliance management system
Managing training, reviewing marketing communications, and analysing complaints to ensure compliant customer outcomes
Ensuring scheduled monitoring and follow-up of reported findings
Reviewing the Compliance Monitoring Plan to ensure optimisation
Collaborating with global Compliance Managers to align local frameworks with global standards
What you'll need
The ability to work well under pressure, manage multiple projects at once, and meet tight deadlines
Knowledge of how to conduct regulatory gap analysis, policy creation, and implementation
A solid understanding of the interplay between compliance risk and business risk
The ability to communicate positively with regulators and members of various internal teams
Multitasking skills with close attention to detail
Excellent analytical, communication, and interpersonal skills
Experience in compliance risk management within a consultancy, compliance function, or regulator
Building a global financial super app isn’t enough. Our Revoluters are a priority, and that’s why in 2021 we launched our inaugural D&I Framework, designed to help us thrive and grow everyday. We're not just doing this because it's the right thing to do. We’re doing it because we know that seeking out diverse talent and creating an inclusive workplace is the way to create exceptional, innovative products and services for our customers. That’s why we encourage applications from people with diverse backgrounds and experiences to join this multicultural, hard-working team.
Important notice for candidates:
Job scams are on the rise. Please keep these guidelines in mind when applying for any open roles.
Only apply through official Revolut channels. We don’t use any third-party services or platforms for our recruitment.
Always double-check the emails you receive. Make sure all communications are being done through official Revolut emails, with an @revolut.com domain.
We won't ask for payment or personal financial information during the hiring process. If anyone does ask you for this, it's a scam. Report it immediately.
By submitting this application, I confirm that all the information given by me in this application for employment and any additional documents attached hereto are true to the best of my knowledge and that I have not wilfully suppressed any material fact. I confirm I have disclosed if applicable any previous employment with Revolut. I accept that if any of the information given by me in this application is in any way false or incorrect, my application may be rejected, any offer of employment may be withdrawn or my employment with Revolut may be terminated summarily or I may be dismissed. By submitting this application, I agree that my personal data will be processed in accordance with Revolut's Candidate Privacy Notice.
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