43 Regulatory Affairs Manager jobs in Singapore

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.

Job Title: Regulatory Affairs Project Lead

Job Summary: This role is responsible for overseeing and executing multiple related projects to identify, lead, and manage continuous improvement initiatives within the Global Strategic Regulatory Affairs department.

The ideal candidate will have experience in complex, technical project management in a regulated industry with knowledge of project management methodologies and processes. They should be able to utilize commonly accepted project management tools to assist in the development of and adherence to a schedule.

• Key Responsibilities Include:
• Developing, implementing, and communicating detailed project plans to achieve overall program objectives;
• Monitoring progress and performance against project plans and developing dashboards and reports to communicate results;
• Proactively identifying changes in project/program scope and proposing appropriate measures to reassess and amend milestones, timeline, and resource allocation;
• Leading, coordinating, and/or participating on cross-functional team activities from Concept Phase through implementation;
• Conducting meetings including agenda, presentations, and minutes;
• Presenting communications demonstrating progress against metrics and strategic objectives;
• Analyzing complex problems including those related to project risks; identifying their impact; establishing probabilities;
• Completing documentation in a timely manner and in accordance with business and quality standards;
• Identifying, leading, and managing continuous improvement projects, incorporating best practices in project management;
• Recommending and implementing PM strategies and enhancements to improve efficiency;
• Assisting in idea and feedback capture and cataloging activities;

Requirements:

• Bachelor's Degree and PMP certification required;
• Typically requires 3-5 years of experience in complex, technical project management in a regulated industry to develop the necessary skills and competencies;
• 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 ensuring 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.

Why Choose Us? Our organization offers a dynamic and supportive work environment, providing opportunities for professional growth and development. We value our employees' contributions and strive to create a culture of innovation and collaboration.

• 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

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.

HSO way of working

In fulfilling our roles, we are

• 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.

We are looking for people who

• 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.

Job Description

About the role

Works closely with and have impact on: Commercial, Consultants, Distributors, QA, CRMA, Marketing

Reports to: Director, Regulatory Affairs APAC (exclude CN & JP)

Function: Global Regulatory Affairs

Role Overview

Efficiently obtaining and maintaining product registrations in APAC countries (exclude China and Japan) by working closely with distributors, consultants, regulators, HOYA affiliates. Representing RA at meetings such as life cycle management, product development, etc.

Duties and Responsibilities

• 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

Requirements

Experience

• 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

Skills/Accreditations

• 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

Academic Qualifications

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

Travel requirements

• 10% of time in a year

By submitting your application, you consent to HOYA Group collecting, disclosing, and retaining your personal data for employment assessment and verification purposes.

If you are shortlisted, we will contact you within three weeks of your application. Thank you for your application and understanding.

Job Summary

   We are seeking a skilled Clinical Research Pharmacist to join our team. In this role, you will be responsible for ensuring the proper management of Investigational Product Controlled Drug Therapeutic Product.

   Key Responsibilities:

• Source, receive, store, prepare, dispense, label, and inventory manage Investigational Products.

• Perform extemporaneous preparation, aseptic compounding, and other dispensing activities as required.

• Manage pharmacy operational activities, including inventory control, maintaining cleanliness of pharmacy areas, and environmental monitoring.

• Ensure compliance with regulations regarding randomization and unblinding procedures for clinical trials.

• Maintain equipment in the pharmacy and perform cross-functional duties as needed.

Qualification Requirements

• Registered Pharmacist license in Singapore.

• Experience in compounding or working in a cleanroom or manufacturing setting is preferred.

Job Overview

The Senior Research Nurse Executive plays a pivotal role in ensuring the safety and well-being of study subjects while maintaining the integrity of clinical trial data. This position involves close monitoring of research participants in early phase clinical trials, with a focus on preparing accurate research metrics and reports.

Responsibilities:

• Deliver high-quality nursing care to patients participating in research studies
• Implement and enforce standards of care and professional codes of conduct
• Guarantee the safety and well-being of study subjects and the reliability of clinical trial data
• Identify and respond to emergency situations, providing assistance as needed
• Prepare comprehensive research metrics and reports for submission
• Conduct intensive monitoring of research participants in early phase clinical trials

Requirements:

• Bachelor's Degree in Nursing or relevant field
• Registered nursing qualification and registration with the relevant nursing board, accompanied by a valid BCLS certificate
• Minimum 5 years' experience in clinical nursing, preferably in clinical trials

This is an exciting opportunity to contribute to groundbreaking research in nursing. If you are a motivated and experienced nurse looking for a new challenge, we encourage you to apply.

Key Performance Indicators (KPIs):

• Ensure accurate and timely preparation of research metrics and reports
• Maintain high standards of patient care and safety
• Collaborate effectively with cross-functional teams to achieve research objectives

Benefits:

• Opportunity to work in a dynamic environment and contribute to cutting-edge research
• Chance to develop skills and expertise in clinical trial management
• Competitive compensation and benefits package

Why Join Us:

We offer a supportive and collaborative work environment that fosters growth and development. Our team is dedicated to advancing research in nursing and improving patient outcomes.