761 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.
  

Regulatory Affairs Manager

Contract Duration of 3-4 months

Come and join us

Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?

"FIND YOUR PLACE" by joining a world-class MNC Healthcare company

Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.

Company Description:

Our client is an MNC Healthcare company. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, they are empowered to tackle the world's toughest health challenges, innovate through science and technology, and transform patient care.

Summary:

The Manager, Regulatory Affairs is responsible for all aspects of regulatory responsibilities in Singapore and Malaysia.

Critical to this role is to combine knowledge of scientific, regulatory, and business issues to enable all products that are developed, manufactured or distributed to meet all the required legislations in the applicable markets.

Additionally, this role is responsible for directing and supporting regulatory related matters such as registration of new products, change management, renewals, claims, advertisement and promotional materials review, labelling support, and external environment surveillance.

This role has market & business level influence and responsibility, and is considered a key opinion leader and an expert resource externally on all regulatory matters in the applicable markets.

This Manager will be actively called upon to influence changing regulations and guidance, interface with external regulatory agencies and trade associations and to provide executive management with regulatory metrics/information. Adheres to company policies, procedures, and supports department objectives.

Main areas of responsibility:

• Responsible for Singapore and Malaysia.
• Direct and support regulatory related matters such as growth & innovation and post-marketing Lifecycle Management (LCM) regulatory activities e.g., new product registrations, change management, renewals, claims, advertisement and promotional materials review, labelling support, and external environment surveillance.
• Oversee creation of global regulatory product development strategies and preparation & submission of marketing approval applications to health authorities to ensure that development plans meet global regulatory requirements.
• Ensure compliance with product post-marketing approval requirements.
• Develop and advance the organization's policies and procedures related to regulatory affairs and compliance to foster a culture of adherence and regulatory integrity.
• Interact with internal regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business. Participate in applicable external trade association or industry working groups to influence policy in alignment with business strategies.
• Identify and address risks and business requirements. Ensure the development and implementation of leading-edge systems and best practices both internally and across sites or company-wide. Identify and implement new regulatory policies, processes and SOPs, as appropriate.
• Provide project leadership or participate as a team member on major initiatives that have high impact to the business. Apply influence across departments and the business.
• Support coordination and back up coordinator to ensure smooth operation and effective use of the Veeva system within the organization (a copy clearance approval for advertisement and promotional material, and local labelling.
• Responsible for managing and coordinating various aspects of the Veeva system to support sales, marketing, Prof Ed and regulatory activities, and ensure compliance with the applicable copy approval procedures.
• Support regulatory projects e.g., advertisement & promotional materials & process audit, copy review process simplification.

Other duties:

• Determine and communicate submission and approval requirements. Communicate application progress to internal stakeholders.
• Compile, prepare, review and submit regulatory documents for product approval and registration with health authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies and complete all regulatory projects as assigned.
• Maintain up-to-date knowledge of regulatory requirements across different markets. Monitor and assess the impact of changing regulations on submission strategies.
• Manage product labelling in line with local regulatory guidelines.
• Review and approve advertisement and promotional materials to ensure compliance with local regulations and requirements.
• Assess acceptability of documentation for submission filing to comply with regulatory requirements for marketing applications, clinical trials and corporate goals, to secure submission approvals.
• Participate in new product development by offering insights and expertise on regulatory requirements, assessing global regulatory strategies, and recommending future strategies and actions.
• Coordinate with external trade association or industry working groups on regulatory

Requirements

• Minimum Degree in any Science course with minimum 5 years of experience
• Proven experience in regulatory affairs within the pharmaceutical or medical device industry. (Medical device related industry experience is preferred.)
• Strong understanding of regulatory requirements and submission processes in the specified markets.
• Expert knowledge, understanding and application of principles, concepts and practices of government regulations.
• Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio.
• Ability to organize and analyze technical data and identify issues or gaps.
• Ability to work cross-functionally and manage multiple projects.
• Excellent organizational and negotiation skills. Ability to effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met

Interested parties, please apply through this link  on APPLY button.

Alternatively, you can share your CV at 

EA License: 94C3609

Reg No: R

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.
#J-18808-Ljbffr

Regulatory Affairs Manager

Contract Duration of 3-4 months

Come and join us!

Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?

“FIND YOUR PLACE” by joining a world-class MNC Healthcare company

Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.

Company Description:

Our client is an MNC Healthcare company. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, they are empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.

Summary:

The Manager, Regulatory Affairs is responsible for all aspects of regulatory responsibilities in Singapore and Malaysia.

Critical to this role is to combine knowledge of scientific, regulatory, and business issues to enable all products that are developed, manufactured or distributed to meet all the required legislations in the applicable markets.

Additionally, this role is responsible for directing and supporting regulatory related matters such as registration of new products, change management, renewals, claims, advertisement and promotional materials review, labelling support, and external environment surveillance.

This role has market & business level influence and responsibility, and is considered a key opinion leader and an expert resource externally on all regulatory matters in the applicable markets.

This Manager will be actively called upon to influence changing regulations and guidance, interface with external regulatory agencies and trade associations and to provide executive management with regulatory metrics/information. Adheres to company policies, procedures, and supports department objectives.

Main areas of responsibility:

• Responsible for Singapore and Malaysia.
• Direct and support regulatory related matters such as growth & innovation and post-marketing Lifecycle Management (LCM) regulatory activities e.g., new product registrations, change management, renewals, claims, advertisement and promotional materials review, labelling support, and external environment surveillance.
• Oversee creation of global regulatory product development strategies and preparation & submission of marketing approval applications to health authorities to ensure that development plans meet global regulatory requirements.
• Ensure compliance with product post-marketing approval requirements.
• Develop and advance the organization’s policies and procedures related to regulatory affairs and compliance to foster a culture of adherence and regulatory integrity.
• Interact with internal regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business. Participate in applicable external trade association or industry working groups to influence policy in alignment with business strategies.
• Identify and address risks and business requirements. Ensure the development and implementation of leading-edge systems and best practices both internally and across sites or company-wide. Identify and implement new regulatory policies, processes and SOPs, as appropriate.
• Provide project leadership or participate as a team member on major initiatives that have high impact to the business. Apply influence across departments and the business.
• Support coordination and back up coordinator to ensure smooth operation and effective use of the Veeva system within the organization (a copy clearance approval for advertisement and promotional material, and local labelling.
• Responsible for managing and coordinating various aspects of the Veeva system to support sales, marketing, Prof Ed and regulatory activities, and ensure compliance with the applicable copy approval procedures.
• Support regulatory projects e.g., advertisement & promotional materials & process audit, copy review process simplification.

Other duties:

• Determine and communicate submission and approval requirements. Communicate application progress to internal stakeholders.
• Compile, prepare, review and submit regulatory documents for product approval and registration with health authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies and complete all regulatory projects as assigned.
• Maintain up-to-date knowledge of regulatory requirements across different markets. Monitor and assess the impact of changing regulations on submission strategies.
• Manage product labelling in line with local regulatory guidelines.
• Review and approve advertisement and promotional materials to ensure compliance with local regulations and requirements.
• Assess acceptability of documentation for submission filing to comply with regulatory requirements for marketing applications, clinical trials and corporate goals, to secure submission approvals.
• Participate in new product development by offering insights and expertise on regulatory requirements, assessing global regulatory strategies, and recommending future strategies and actions.
• Coordinate with external trade association or industry working groups on regulatory

Requirements

• Minimum Degree in any Science course with minimum 5 years of experience
• Proven experience in regulatory affairs within the pharmaceutical or medical device industry. (Medical device related industry experience is preferred.)
• Strong understanding of regulatory requirements and submission processes in the specified markets.
• Expert knowledge, understanding and application of principles, concepts and practices of government regulations.
• Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio.
• Ability to organize and analyze technical data and identify issues or gaps.
• Ability to work cross-functionally and manage multiple projects.
• Excellent organizational and negotiation skills. Ability to effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met

Interested parties, please apply through this link  on APPLY button.

Alternatively, you can share your CV at 

EA License: 94C3609

Reg No: R

Location
Singapore - 138 Market Street, CapitaGreen, #32 01

Brookfield Culture

Brookfield has a unique and dynamic culture. We seek team members who have a long-term focus and whose values align with our Attributes of a Brookfield Leader: Entrepreneurial, Collaborative and Disciplined. Brookfield is committed to the development of our people through challenging work assignments and exposure to diverse businesses.

This role will support legal, regulatory, and compliance activities for Brookfield’s licensed entities and operations in Singapore. The role includes assisting with transaction execution, legal documentation, regulatory monitoring, compliance reporting, and entity governance in collaboration with cross-functional teams.

• Assist in ensuring adherence to applicable MAS regulations and internal Brookfield policies
• Monitor day-to-day compliance with regulatory requirements, particularly those under MAS frameworks
• Coordinate and assist with regulatory filings, audits, and inspections
• Support the development and maintenance of compliance manuals, policies, and procedures
• Support transactional legal work including due diligence, document review (NDAs, engagement letters, agreements), and execution processes
• Coordinate legal aspects of portfolio activities such as secondary transactions, bolt-on investments, and refinancing
• Assist in the preparation and review of marketing materials and cross-border fund offering documents
• Conduct and support KYC and AML processes for vendors and deal counterparties
• Maintain legal documentation, trackers, and ensure compliance with corporate governance protocols
• Participate in legal and regulatory risk assessments and conduct horizon scanning for emerging regulatory issues
• Draft internal compliance documentation, contribute to policy updates, and provide training support
• Coordinate with external counsel and internal stakeholders to manage post-closing obligations and ensure timely execution of deliverables
• Participate in regional and global Legal & Regulatory projects as needed

• Qualified lawyer with 2–4 years of post-qualification experience, preferably within a CMS-licensed fund manager or financial institution
• Experience with Singapore financial regulation and MAS frameworks
• Understanding of corporate law, transaction support, and compliance in asset management or related sectors beneficial
• Strong drafting, analytical, and communication skills
• Proficient with Microsoft Office tools and document management systems

Brookfield Asset Management does not accept unsolicited resumes from recruitment agencies. Any resumes submitted without a prior request from us will be considered the property of Brookfield and we may choose to engage with the candidate directly. We respectfully request that recruitment agencies do not contact us regarding this position.

Brookfield is committed to maintaining a Positive Work Environment that is safe and respectful; our shared success depends on it. Accordingly, we do not tolerate workplace discrimination, violence or harassment.

We are proud to create a diverse environment and are proud to be an equal opportunity employer. We are grateful for your interest in this position; however, only candidates selected for pre-screening will be contacted.

Associate, Compliance - Legal & Regulatory page is loadedAssociate, Compliance - Legal & Regulatory Apply locations Singapore time type Full time posted on Posted 30+ Days Ago job requisition id R

Location

Brookfield Culture

Brookfield has a unique and dynamic culture. We seek team members who have a long-term focus and whose values align with our Attributes of a Brookfield Leader: Entrepreneurial, Collaborative and Disciplined. Brookfield is committed to the development of our people through challenging work assignments and exposure to diverse businesses.

Job Description

About the role

This role will support legal, regulatory, and compliance activities for Brookfield’s licensed entities and operations in Singapore. The role includes assisting with transaction execution, legal documentation, regulatory monitoring, compliance reporting, and entity governance in collaboration with cross-functional teams.

Responsibilities:

• Assist in ensuring adherence to applicable MAS regulations and internal Brookfield policies
• Monitor day-to-day compliance with regulatory requirements, particularly those under MAS frameworks
• Coordinate and assist with regulatory filings, audits, and inspections
• Support the development and maintenance of compliance manuals, policies, and procedures
• Support transactional legal work including due diligence, document review (NDAs, engagement letters, agreements), and execution processes
• Coordinate legal aspects of portfolio activities such as secondary transactions, bolt-on investments, and refinancing
• Assist in the preparation and review of marketing materials and cross-border fund offering documents
• Conduct and support KYC and AML processes for vendors and deal counterparties.
• Maintain legal documentation, trackers, and ensure compliance with corporate governance protocols
• Participate in legal and regulatory risk assessments and conduct horizon scanning for emerging regulatory issues
• Draft internal compliance documentation, contribute to policy updates, and provide training support
• Coordinate with external counsel and internal stakeholders to manage post-closing obligations and ensure timely execution of deliverables
• Participate in regional and global Legal & Regulatory projects as needed

About you

• Qualified lawyer with 2–4 years of post-qualification experience, preferably within a CMS-licensed fund manager or financial institution
• Experience with Singapore financial regulation and MAS frameworks
• Understanding of corporate law, transaction support, and compliance in asset management or related sectors beneficial
• Strong drafting, analytical, and communication skills
• Proficient with Microsoft Office tools and document management systems

Brookfield Asset Management does not accept unsolicited resumes from recruitment agencies. Any resumes submitted without a prior request from us will be considered the property of Brookfield and we may choose to engage with the candidate directly. We respectfully request that recruitment agencies do not contact us regarding this position.

Brookfield is committed to maintaining a Positive Work Environment that is safe and respectful; our shared success depends on it. Accordingly, we do not tolerate workplace discrimination, violence or harassment.

Brookfield Asset Management is a leading global alternative asset manager with over US$1 trillion of assets under management across real estate, infrastructure, renewable power and transition, private equity and credit.

Brookfield owns and operates long-life assets and businesses, many of which form the backbone of the global economy. Utilizing its global reach, access to large-scale capital and operational expertise, Brookfield offers a range of alternative investment products to investors around the world—including public and private pension plans, endowments and foundations, sovereign wealth funds, financial institutions, insurance companies and private wealth investors.

Brookfield Asset Management Ltd. (BAM) is a public company listed on the New York (NYSE: BAM) and Toronto (TSX: BAM) stock exchanges. Brookfield Corporation is a public company listed on the New York (NYSE: BN) and Toronto (TSX: BN) stock exchanges.