60 Regulatory Affairs Manager Jobs - July 2026 - High Salaries

Showing 60 jobs results for "regulatory affairs manager"
Never miss any updates for Regulatory Affairs Manager jobs
premium banner
Chat Available
MYR4,000 - MYR5,000 Per Month

Bandar Kuala Lumpur, WP Kuala Lumpur

Near Train Station
  • Assist in sourcing and evaluating new ingredients, materials and suppliers
  • Support cross-functional coordination across operations, marketing and management teams
  • Handle ad hoc regulatory, compliance and product-related matters as they arise ...
Regulatory Affairs Product Development
+4
Posted
3 days ago
MYR4,000 - MYR5,000 Per Month

Bandar Kuala Lumpur, WP Kuala Lumpur

Near Train Station
  • Assist in sourcing and evaluating new ingredients, materials and suppliers
  • Support cross-functional coordination across operations, marketing and management teams
  • Handle ad hoc regulatory, compliance and product-related matters as they arise ...
Regulatory Affairs Product Development
+4
Posted
25 days ago
MYR4,000 - MYR5,000 Per Month

Bandar Kuala Lumpur, WP Kuala Lumpur

Near Train Station
  • Assist in sourcing and evaluating new ingredients, materials and suppliers
  • Support cross-functional coordination across operations, marketing and management teams
  • Handle ad hoc regulatory, compliance and product-related matters as they arise ...
Regulatory Affairs Product Development
+4
Posted
25 days ago
Undisclosed
  • Provide guidance and functional support to regulatory team member.
  • Monitor & interpret the local & global regulatory environment for significant changes & communicate implications of such changes to key stakeholders.
  • Develop excellent relationships & partnerships with Health Authorities and regulatory KEEs. ...
Posted
a month ago
SGD4,500 - SGD4,500 Per Month

Singapore

  • Verify accuracy and validate reports to ensure compliance and quality
  • Respond promptly and accurately to queries from the Ministry of Health
  • Manage multiple tasks efficiently under pressure while maintaining attention to detail ...
Posted
12 days ago
Undisclosed

Singapore

  • Create regulatory awareness level as determined within the organization.
  • Supports implementation of simplified yet robust regulatory processes for registrations and labeling deviations across the HPM Businesses.
  • Introduce and implement the necessary regulatory processes and tools required to ensure first time right in submissions. ...
Posted
25 days ago
Undisclosed

Singapore

  • Manage labeling changes, safety updates, artwork development and artwork approval of packaging material components.
  • Build effective working relations with the regulatory agency and follow-up closed on approval of products registration and variations
  • Work with all appropriate local functions to develop and implement the best regulatory strategies/plans to support commercial goals and product launch excellence. ...
Posted
9 days ago
Undisclosed

Singapore

  • Manage labeling changes, safety updates, artwork development and artwork approval of packaging material components.
  • Build effective working relations with the regulatory agency and follow-up closed on approval of products registration and variations
  • Work with all appropriate local functions to develop and implement the best regulatory strategies/plans to support commercial goals and product launch excellence. ...
Posted
9 days ago
Undisclosed

KL City

  • This Regulatory Affairs Manager will be responsible for driving regulatory strategy, submissions, and lifecycle management, working closely with cross-functional teams across the business.
  • Candidates for this role of Regulatory Affairs Manager would bring solid RA experience within pharmaceuticals or biologics, with a strong understanding of Malaysian regulatory requirements.
  • For a confidential discussion, please apply. ...
Posted
6 days ago
Undisclosed

Singapore

  • Create regulatory awareness level as determined within the organization.
  • Supports implementation of simplified yet robust regulatory processes for registrations and labeling deviations across the HPM Businesses.
  • Introduce and implement the necessary regulatory processes and tools required to ensure first time right in submissions. ...
Posted
4 days ago
Undisclosed

Hong Kong

Posted
25 days ago

PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD.

SGD7,000 - SGD7,000 Per Month

Singapore

  • • Manage the preparation of regulatory submissions, including product registrations, licenses, and approvals for new and existing products.
  • • Draft, revise and review the relevant submission documents.
  • • Provide regulatory guidance for the labelling, formula compliance, advertising and marketing of new and existing products across Southeast Asia region sales channels. ...
Posted
8 days ago
Undisclosed

KL City

  • Support REACH and other global regulatory submissions while ensuring regional applicability
  • Manage product safety data within SAP systems and drive system enhancements with regional and global teams
  • Identify emerging regulatory risks and advise stakeholders on mitigation and compliance strategies ...
Posted
18 days ago
SGD7,000 - SGD7,000 Per Month

Singapore

  • Manages interface with internal and external regulatory and cross-functional stakeholders, including direct/indirect interaction with regulatory agencies.
  • Implements regulatory strategies for assigned projects for countries in JAPAC region in line with area commercial priorities in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
  • Partners with intercontinental commercial, market access and medical to ensure business needs are met. ...
Posted
15 days ago
MYR8,000 - MYR10,000 Per Month
  • Compliance Monitoring:
  • Ensure the company fulfills all MIDA compliance conditions, including the 80% local workforce ratio and the 25% Managerial, Technical, and Supervisory (MTS) staff threshold.
  • Tax & Duty Exemptions: ...
Posted
14 days ago
Undisclosed

Singapore

  • We are partnering with a global Medical Devices MNC with a wide range of medical and surgical devices across consumables and equipment. With a large global team of over 40,000 employees and more than 20 manufacturing sites worldwide, the business has a strong heritage of over 50 years and is now actively expanding its footprint across emerging Asia markets. As the regional team continues to grow, they are now looking for an experienced QA/RA Manager to lead their Quality and Regulatory function across the emerging markets.
  • Responsibilities
  • Reporting to the General Manager, the QA/RA Manager will be responsible for developing and executing regulatory strategies across Southeast Asia, overseeing product registrations, renewals, and license maintenance for hospital consumables (Class 1 – 3) across emerging markets. This includes preparing and submitting regulatory dossiers to local authorities via distributors and RA consultants, managing adverse events and field safety corrective action (FSCA) reporting, reviewing labels and marketing materials for regulatory compliance, and performing continuous regulatory intelligence scans. ...
Posted
5 days ago
Undisclosed

Singapore

  • We are partnering with a global Medical Devices MNC with a wide range of medical and surgical devices across consumables and equipment. With a large global team of over 40,000 employees and more than 20 manufacturing sites worldwide, the business has a strong heritage of over 50 years and is now actively expanding its footprint across emerging Asia markets. As the regional team continues to grow, they are now looking for an experienced QA/RA Manager to lead their Quality and Regulatory function across the emerging markets.
  • Responsibilities
  • Reporting to the General Manager, the QA/RA Manager will be responsible for developing and executing regulatory strategies across Southeast Asia, overseeing product registrations, renewals, and license maintenance for hospital consumables (Class 1 – 3) across emerging markets. This includes preparing and submitting regulatory dossiers to local authorities via distributors and RA consultants, managing adverse events and field safety corrective action (FSCA) reporting, reviewing labels and marketing materials for regulatory compliance, and performing continuous regulatory intelligence scans. ...
Posted
14 days ago
Undisclosed

Hong Kong

Posted
3 days ago
Undisclosed

Singapore

  • Expedites commercialization of new indications and line extension by providing regional regulatory inputs to identify barriers and needs.
  • Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals
  • Provides input in post-registration activities, including labeling changes ...
Posted
5 days ago
Undisclosed

Singapore

  • Pre-market activities: product assessment and new product registration
  • Post market activities: variation application, product licence renewal and maintenance
  • Permit application: named-patient permit, advertising permit & sale promotion permit and any permit to allow importation or exportation. ...
Posted
19 days ago
Undisclosed

Singapore

  • A minimum of 8 years’ experience in regulatory affairs and quality within a medical device company.
  • Knowledge of ASEAN Medical Device Directive, US FDA regulation and EU Medical Device Regulation, Taiwan FDA.
  • Familiar with product design, development and manufacturing processes to effectively interpret technical documentation and reports required for product registration and regulatory submissions. ...
Posted
16 days ago
MYR8,000 - MYR10,000 Per Month
  • Compliance Monitoring:
  • Ensure the company fulfills all MIDA compliance conditions, including the 80% local workforce ratio and the 25% Managerial, Technical, and Supervisory (MTS) staff threshold.
  • Tax & Duty Exemptions: ...
Posted
22 days ago
Undisclosed

Hong Kong

Posted
5 days ago
Undisclosed
WFH

Singapore

  • Regulatory planning globally and alongside other functions within ORD and OMS (eg: supply, EtE planning and PSM) including efficiency and optimization/simplification strategies
  • Leads supply optimization discussions (stock build/stock depletion/registration deletion/commercialization of validation batches).
  • Sets up priorities, organizes, oversees and monitors activities, towards division’s and country's objectives achievement in compliance with policies and standards. ...
Posted
4 days ago
Undisclosed
WFH

KL City

  • Regulatory planning globally and alongside other functions within ORD and OMS (eg: supply, EtE planning and PSM) including efficiency and optimization/simplification strategies
  • Leads supply optimization discussions (stock build/stock depletion/registration deletion/commercialization of validation batches).
  • Sets up priorities, organizes, oversees and monitors activities, towards division’s and country's objectives achievement in compliance with policies and standards. ...
Posted
2 days ago
Undisclosed

Singapore

  • Pre-market activities: product assessment and new product registration
  • Post market activities: variation application, product licence renewal and maintenance
  • Permit application: named-patient permit, advertising permit & sale promotion permit and any permit to allow importation or exportation. ...
Posted
25 days ago
Undisclosed

Singapore

  • We are partnering with a global Medical Devices MNC with a wide range of medical and surgical devices across consumables and equipment. With a large global team of over 40,000 employees and more than 20 manufacturing sites worldwide, the business has a strong heritage of over 50 years and is now actively expanding its footprint across emerging Asia markets. As the regional team continues to grow, they are now looking for an experienced QA/RA Manager to lead their Quality and Regulatory function across the emerging markets.
  • Responsibilities
  • Reporting to the General Manager, the QA/RA Manager will be responsible for developing and executing regulatory strategies across Southeast Asia, overseeing product registrations, renewals, and license maintenance for hospital consumables (Class 1 – 3) across emerging markets. This includes preparing and submitting regulatory dossiers to local authorities via distributors and RA consultants, managing adverse events and field safety corrective action (FSCA) reporting, reviewing labels and marketing materials for regulatory compliance, and performing continuous regulatory intelligence scans. ...
Posted
19 days ago
Undisclosed

Singapore

  • Assess and review scientific and technical data provided by subject matter experts for regulatory submissions, ensuring alignment with JAPAC and regional requirements, identifying gaps, and developing mitigation strategies as needed.
  • Effectively present regulatory data to RA affiliates and ensure complete and timely responses to authorities for Clinical trial applications, New Drug/ New indication applications and any other assigned applications.
  • Collaborate cross-functionally with Commercial, Medical Affairs, Market Access, Clinical Development, and CMC teams, represent the regulatory function and provide strategic input to enable product registrations, mitigate regulatory risks, and ensure compliance. ...
Posted
16 days ago
Undisclosed

KL City

  • Leads supply optimization discussions (stock build/stock depletion/registration deletion/commercialization of validation batches).
  • Sets up priorities, organizes, oversees and monitors activities, towards division’s and country's objectives achievement in compliance with policies and standards.
  • Lead and coordinates E2E regulatory process for supply chain changes as per guidelines for the APJ (inc China) region as well as regulatory requirements from other regions globally ...
Posted
a month ago
Undisclosed

Singapore

  • Leads supply optimization discussions (stock build/stock depletion/registration deletion/commercialization of validation batches).
  • Sets up priorities, organizes, oversees and monitors activities, towards division’s and country's objectives achievement in compliance with policies and standards.
  • Lead and coordinates E2E regulatory process for supply chain changes as per guidelines for the APJ (inc China) region as well as regulatory requirements from other regions globally ...
Posted
a month ago