95 Regulatory Affairs Manager jobs in Singapore

Job Summary:

We are seeking a skilled Project Manager to oversee and execute multiple related projects within our Global Strategic Regulatory Affairs Program.

Key Responsibilities:

• Develop, communicate, and execute detailed project plans to achieve overall program goals;
• Monitor progress and performance against project plans and develop dashboards and reports to communicate progress;
• Proactively identify changes in project/program scope and propose appropriate measures to reassess and amend milestones, budget, and timeline;
• Lead, coordinate, and/or participate on cross-functional team activities from concept phase through implementation;
• Conduct meetings, including agenda, presentations, and minutes;
• Present communications demonstrating progress against budget, metrics, and strategic objectives;
• Analyze complex problems, including those related to project risks, identify their impact, establish probabilities;
• Complete documentation in a timely manner and in accordance with business and quality standards;
• Identify, lead, and manage continuous improvement projects, incorporating best practices in program management;
• Recommend and implement PM strategies and enhancements to improve efficiency;
• Assist in idea and feedback capture and cataloging activities;

Required Skills and Qualifications:

• Bachelor's Degree and PMP certification required;
• Typically requires 3-5 years of experience in complex, technical program/project management in a regulated industry to develop the competence required to meet the skills and responsibilities of the position;
• Extensive knowledge of and competency in project management methodology and processes;
• Knowledge and experience with business excellence methodologies and processes;
• Decision-making and problem-solving skills, demonstrated good judgment;
• Ability to be creative in achieving objectives while assuring compliance to internal and external requirements;
• Ability to utilize commonly accepted project management tools to assist in the development of and adherence to a schedule;
• Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors;
• Ability to form and develop interpersonal, professional relationships, display socially and professionally appropriate behavior;
• Ability to work independently and in groups, ability to work cross-functionally and in a matrixed environment;
• Ability and aptitude to use various types of databases and computer software;
• Ability to prioritize work tasks;
• Ability to communicate effectively with good written, oral, and presentation skills.

Additional Information:

• Salary open for negotiation;
• Contract duration: 12-month contract renewable and convertible;
• Working days and hours: Mon to Friday, 9am to 6pm;
• Location: Bugis, DUO Tower.

Are you a seasoned Regulatory Affairs expert looking to take on a leadership role in program management?

We are seeking a skilled Regulatory Affairs Program Manager to join our team. As a key member of our Global Strategic Regulatory Affairs Projects team, you will be responsible for the management and execution of multiple related projects, identifying, leading, and managing continuous improvement projects.

The successful candidate will design, develop, communicate, and execute detailed project plans to achieve overall program goals, monitor progress and performance against project plans, and develop dashboards and reports to communicate progress. They will also proactively identify changes in project/program scope and propose appropriate measures to reassess and amend milestones and timelines.

Key Responsibilities:

• Project Planning : Develop and implement project plans, manage project schedules, and coordinate cross-functional activities.
• Performance Monitoring : Track project progress, identify areas for improvement, and develop strategies to mitigate risks.
• Scope Management : Identify and manage changes in project scope, developing and implementing corrective actions as needed.
• Team Leadership : Lead and motivate cross-functional teams to achieve project objectives.

• Bachelor's Degree and PMP certification required;
• Typically requires 3-5 years of experience in complex, technical program/project management in a regulated industry;
• Extensive knowledge of and competency in project management methodology and processes;
• Decision-making and problem-solving skills; demonstrated good judgment;
• Ability to prioritize tasks, work independently, and collaborate with others.

• Responsible to design, develop, communicate, and execute detailed project plans to achieve overall program goals;
• Monitor progress and performance against project plans and develop dashboards and reports to communicate progress
• Proactively identify changes in project/program scope and propose appropriate measures to reassess and amend milestones, budget, and timeline.
• Lead, coordinate and/or participate on cross-functional team activities from Concept Phase through implementation;
• Conduct meetings including agenda, presentations, and minutes
• Monitor and present communications demonstrating progress against budget, metrics, and strategic objectives;
• Analyze complex problems including those related to project risks; identify their impact; establish probabilities;
• Responsible for completing documentation in a timely manner and in accordance with business and quality standards;
• Identify, lead, and manage continuous improvement projects, incorporating best practices in program management
• Recommend and implement PM strategies and enhancements to improve efficiency;
• Assist in idea and feedback capture and cataloging activities

• Bachelor's Degree and PMP certification required
• Typically requires 3-5 years of experience in complex, technical program / project management in a regulated industry to develop the competence required to meet the skills and responsibilities of the position;
• Extensive knowledge of and competency in project management methodology and processes;
• Knowledge and experience with business excellence methodologies and processes;
• Decision-making and problem-solving skills; demonstrated good judgment;
• Ability to be creative in achieving objectives while assuring compliance to internal and external requirements;
• Ability to utilize commonly accepted project management tools to assist in the development of and adherence to a schedule;
• Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors;
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior;
• Ability to work independently and in groups; ability to work cross-functionally and in a matrixed environment;
• Ability and aptitude to use various types of databases and computer software;
• Ability to prioritize their work tasks;
• Ability to communicate effectively with good written, oral, and presentation skills.

• Salary - Open for negotiation
• Contract duration: 12-month contract renewable and convertible
• Commencement Date: Immediate
• Working days and hours: Mon to Friday, 9am to 6pm
• Location: Bugis, DUO Tower

Job Summary:

Responsible for management and execution of multiple related projects and to identify, lead, and manage continuous improvement projects for the Program Management Office responsible for Global Strategic Regulatory Affairs Projects, incorporating best practices in program management

Job Scope:

• Responsible to design, develop, communicate, and execute detailed project plans to achieve overall program goals;
• Monitor progress and performance against project plans and develop dashboards and reports to communicate progress
• Proactively identify changes in project/program scope and propose appropriate measures to reassess and amend milestones, budget, and timeline.
• Lead, coordinate and/or participate on cross-functional team activities from Concept Phase through implementation;
• Conduct meetings including agenda, presentations, and minutes
• Monitor and present communications demonstrating progress against budget, metrics, and strategic objectives;
• Analyze complex problems including those related to project risks; identify their impact; establish probabilities;
• Responsible for completing documentation in a timely manner and in accordance with business and quality standards;
• Identify, lead, and manage continuous improvement projects, incorporating best practices in program management
• Recommend and implement PM strategies and enhancements to improve efficiency;
• Assist in idea and feedback capture and cataloging activities

Job Requirement:

• Bachelor's Degree and PMP certification required
• Typically requires 3-5 years of experience in complex, technical program / project management in a regulated industry to develop the competence required to meet the skills and responsibilities of the position;
• Extensive knowledge of and competency in project management methodology and processes;
• Knowledge and experience with business excellence methodologies and processes;
• Decision-making and problem-solving skills; demonstrated good judgment;
• Ability to be creative in achieving objectives while assuring compliance to internal and external requirements;
• Ability to utilize commonly accepted project management tools to assist in the development of and adherence to a schedule;
• Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors;
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior;
• Ability to work independently and in groups; ability to work cross-functionally and in a matrixed environment;
• Ability and aptitude to use various types of databases and computer software;
• Ability to prioritize their work tasks;
• Ability to communicate effectively with good written, oral, and presentation skills.

Additional Information:

• Salary – Open for negotiation
• Contract duration: 12-month contract renewable and convertible
• Commencement Date: Immediate
• Working days and hours: Mon to Friday, 9am to 6pm
• Location: Bugis, DUO Tower

Job Summary:

Responsible for management and execution of multiple related projects and to identify, lead, and manage continuous improvement projects for the Program Management Office responsible for Global Strategic Regulatory Affairs Projects, incorporating best practices in program management

Job Scope:

• Responsible to design, develop, communicate, and execute detailed project plans to achieve overall program goals;
• Monitor progress and performance against project plans and develop dashboards and reports to communicate progress
• Proactively identify changes in project/program scope and propose appropriate measures to reassess and amend milestones, budget, and timeline.
• Lead, coordinate and/or participate on cross-functional team activities from Concept Phase through implementation;
• Conduct meetings including agenda, presentations, and minutes
• Monitor and present communications demonstrating progress against budget, metrics, and strategic objectives;
• Analyze complex problems including those related to project risks; identify their impact; establish probabilities;
• Responsible for completing documentation in a timely manner and in accordance with business and quality standards;
• Identify, lead, and manage continuous improvement projects, incorporating best practices in program management
• Recommend and implement PM strategies and enhancements to improve efficiency;
• Assist in idea and feedback capture and cataloging activities

Job Requirement:

• Bachelor’s Degree and PMP certification required
• Typically requires 3-5 years of experience in complex, technical program / project management in a regulated industry to develop the competence required to meet the skills and responsibilities of the position;
• Extensive knowledge of and competency in project management methodology and processes;
• Knowledge and experience with business excellence methodologies and processes;
• Decision-making and problem-solving skills; demonstrated good judgment;
• Ability to be creative in achieving objectives while assuring compliance to internal and external requirements;
• Ability to utilize commonly accepted project management tools to assist in the development of and adherence to a schedule;
• Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors;
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior;
• Ability to work independently and in groups; ability to work cross-functionally and in a matrixed environment;
• Ability and aptitude to use various types of databases and computer software;
• Ability to prioritize their work tasks;
• Ability to communicate effectively with good written, oral, and presentation skills.

Additional Information:

• Salary – Open for negotiation
• Contract duration: 12-month contract renewable and convertible
• Commencement Date: Immediate
• Working days and hours: Mon to Friday, 9am to 6pm
• Location: Bugis, DUO Tower

Job Scope:

• Manage investigational products, controlled drugs, and therapeutic products – including sourcing, receiving, storage, labelling, dispensing, reconciliation, and documentation
• Perform extemporaneous preparations, aseptic compounding, and related dispensing duties
• Maintain pharmacy operations including inventory management, cleanliness, and environmental monitoring
• Ensure proper management of randomization and unblinding procedures for blinded clinical trials
• Oversee handling and maintenance of pharmacy equipment
• Support cross-functional operations and ad-hoc duties as required

Requirement:

• Singapore-Registered Pharmacist
• Experience in compounding, cleanroom, or manufacturing setting will be good

Interested candidates, please forward your resume to

Consultant: Huang Jingsheng Kevyn (R13338)

Recruit Express Pte Ltd (99C4599)

This is an exciting opportunity for a Freelance Clinical Trial Nurse to join our research team. As a key member of our team, you will play a vital role in ensuring the success of clinical trials.

• Assist the research team in various tasks related to clinical trials.
• Ensure the smooth execution of trial procedures and protocols.
• Maintain accurate and detailed records of trial progress.

Required Skills and Qualifications:

We are looking for individuals with the following skills and qualifications:

• Strong knowledge of clinical trial procedures and protocols.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.

Benefits:

As a Freelance Clinical Trial Nurse, you will have the opportunity to work on a variety of projects and develop your skills and expertise. You will also have access to ongoing training and professional development opportunities.

Other Opportunities:

Working as a Freelance Clinical Trial Nurse offers many opportunities for career advancement and personal growth. You will have the chance to work with a dynamic team and contribute to the success of clinical trials.

This is a full-time contract position with 5.5 days of office hours per week.

We are looking for a highly motivated and organized individual with a passion for clinical research to join our team as a Research Coordinator.

The selected candidate will be responsible for coordinating studies, managing budgets, and working closely with the Principal Investigator (PI) to achieve project goals.

The ideal candidate will have strong interpersonal skills, experience in clinical research, and knowledge of healthcare administration.

We offer a dynamic and supportive work environment with opportunities for professional growth and development.

The successful candidate will have opportunities for career growth and personal development.

• Coordinate with the team and clinics to set up study sites, including making logistics arrangements and preparing for studies and meetings.
• Manage study budget, tracking expenses, and making financial payments.
• Coordinate studies across multiple sites and collaborate with other teams as needed.
• Monitor study progress and coordinate regular reviews with the study team.
• Assist in preparing study-related presentations and materials.
• Evaluate research results and provide feedback.

• Possess a relevant Diploma or Degree.

• This role is ideal for individuals with a strong understanding of research protocols.
• We are looking for a motivated individual who is passionate about clinical trials.

• Accountable for our own capabilities and development.
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

• See beyond self and are impact focused.
• Consider the needs, challenges, and objectives of every person they interact with
• Exhibit positive reinforcement to help others succeed.

• Participate in projects and provide regulatory strategy and timelines where required
• Ensure regulatory submissions are executed on-time and in a cost-effective manner
• Maintain regulatory licenses and on-time renewals to avoid supply disruption
• Adequate and effective relationship management, as well as ensuring contractual agreements are in place (where applicable) with Third Party License Holders, Regulatory Agencies, Consultants, stakeholders to meet the regulatory goals
• Ensure regulatory activities performed are in compliance with both internal and external regulations/requirements
• Support the business in obtaining timely regulatory documentation required to import/export and/or to obtain market access/reimbursement/tender approval
• Represent as Global RA lead relating to change controls initiatives/activities, providing clear communication on the proposed changes and working closely with SMEs, regional RAs to obtaining timely and accurate global RA impact assessment and formulate the global RA strategy with minimal business impact
• Prompt review and approval of promotional and marketing materials, ensure regulatory compliance with internal and external requirements
• Monitor changes in local standards, regulations, guidance documents etc. and inform the relevant stakeholders about the associated impact (where applicable)
• Provide regulatory expertise within the RA team (e.g. RA Specialists) and to other stakeholders on regulatory issues
• Oversee Global registration status and perform regulatory control for product release
• Support internal audit and follow up on the actions item (if any)
• Participate in Post market activities (e.g. AE, FSCA) where required
• Work closely with CTM on the clinical requirements where necessary
• Manage the document request portal to support global registrations

• Minimum 5 years of APAC Regulatory Affairs experience in Medical Device Industry, especially in South East Asia, Korea, in a multi-cultural environment
• Experienced in Class 3/Class C, D general devices preferred

• Hands-on and in-depth technical and clinical experience in regulatory strategy, dossier preparation, regulatory submissions, queries responses
• Excellent interpersonal and communication skills
• Initiative and excellent problem solving skills
• Able to work independently with minimal supervision
• Meticulous and attention to details
• Fluent command of English, strong and effective technical writing, documentation and communication across different departments and organizations.
• Knowledge in other Asian languages would be an advantage

• Minimally University Degree in Science (Pharmacy, Pharmaceutical Science) or related degree/diploma in Science, Engineering, and/or Biotechnology.

• 10% of time in a year