103 Regulatory Affairs Positions 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.

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.

Principal Task: The successful candidate will first and foremost be responsible for regulatory affairs and product registrations for all SciMed products. The candidate will be the focal point of contact for advice on regulatory guidelines and activities. Besides regulatory affairs, the candidate will also support the Management Representative in ensuring an effective Quality Management System (QMS) and local implementation of PHC's compliance policies and ensure full adherence where necessary.

1. Regulatory Affairs

• Understand relevant regulatory regulations, policies & procedures behind the company's business activities and products
• Ensure product and company's compliance with regulations for maintenance of approvals
• Maintain ISO and GDPMDS records, and work closely with the ISO/GDPMDS team to provide timely updates on company's regulatory and licensing matters
• Preparation and submission of regulatory applications, including creating and maintaining templates and ensuring completion of submissions
• Advise management on regulatory processes, compliance and updates to policies
• Responsible for the maintenance of regulatory documentation databases
• Develop and maintain communication with regulatory agencies regarding submission strategies, compliancetest requirements, potential regulatory pathways, or clarification, and follow-up on submissions and reviews quality management systemo new product(s) launch in local and/or regional markets
• Main contact point for various regulatory-related internal inquiries regarding logistics, pre/post-marketing events in addressing customers' requirements.
• Support the country managers in medical device regulations or other regulations for regional countries
• Liaise with related departments in the PHC Group

2. Quality Management System

• Support the Management Representative in the company quality management system
• Maintain and update the document control system to ensure all quality-related documents are easily accessible, properly categorized, and up to date.
• Oversee the implementation and maintenance of Quality Management Systems (QMS) in accordance with ISO9001, GDPMDS and other relevant standards.
• Review and update ISO 9001 & GDPMDS documents when necessary and maintain records.
• Review and ensure all documents, including SOPs, work instructions, manuals, and forms, meet regulatory and company standards.
• Handle quality related matters such as non-conformances, customer complaints, change notification.
• Handle customer or supplier related enquiries, questionnaire and etc.
• Prepare for internal and external audits and ensure successful outcomes, tackle audit findings and recommendations in a timely manner
• Follow-up and verify corrective/preventive action (CAPA) effectiveness.
• Provide ISO 9001 and GDPMDS orientation to new employees

3. Compliance

• Coordinate, schedule and conduct required compliance orientation and training for employees
• Responsible to ensure compliance to regulations related to export controls and maintain records
• Provide support to employees on regulatory requirement and compliance procedures.
• Serve as a BizSafe member by overseeing and coordinating the preparation, management, and maintenance of all risk management and related documentation. Ensure all required documents are completed, up-to-date, and in compliance with BizSafe standards and regulations.

REQUIREMENTS

Candidates should bring with them

• A Degree in Life Sciences, Biomedical or any other related discipline.
• Minimum 2 years' experience in performing a similar job scope.
• Relevant experience in regulatory affairs will be advantageous
• Good knowledge and application of Microsoft 365.
• Able to work under a matrix reporting structure.
• Good organizational and time management skills.
• A strong database experience (Access, Excel) to set up functions, enter data or process information.
• Excellent interpersonal, presentation and verbal/written communications skills.
• Meticulous, able to work independently and timely in meeting deadlines.
• Integrity with a history of ethical decision-making is essential
• Sound knowledge of the regulatory requirements and legal framework for products and industry trends in the Asian Region.
• Knowledge in GDPMD, ISO9001, IVDR preferred.
• Familiarity with Health Science Authority's regulatory on medical devices, product registration, field safety correction and licensing requirements.

We are seeking a highly motivated and organized Regulatory Affairs Specialist to fill this key role. The ideal candidate will have a strong attention to detail, excellent organizational skills, and the ability to work effectively in a fast-paced environment.

• Support submission of applications and variations for clinical trials and marketing authorisation across all pipelines
• Contribute to regulatory assessment of submission requirements based on relevant regulations
• Assist with administrative tasks necessary to support regulatory activities
• Review and provide input for regulatory documents
• Support additional duties as assigned

• Degree in Biological, Chemistry, or a related field
• No prior experience is required. An interest in Regulatory Affairs is essential
• A keen learner with a strong attention to detail and organisational skills is required
• Proficiency in English (written and spoken) is mandatory

This is an exciting opportunity for someone looking to develop their career in Regulatory Affairs.

The role of a Regulatory Manager in the Asia Pacific region involves serving as the primary liaison between Head Quarters and partners on regulatory matters. Key responsibilities include coordinating queries, variations, submissions, and registrations; handling product issues or complaints, as well as quality issues; updating PDM and Packaging records; maintaining past dossiers and attending to queries relating to approved dossiers and dossier information; recording trademarks for APAC countries; maintaining GTIN information for products marketed in APAC countries; monitoring, reporting, and documenting ICSRs for products marketed in Singapore; executing recall procedures and documentation for products marketed in Singapore; coordinating recall procedures, execution, and documentation for products marketed in APAC countries in accordance with local regulatory requirements; preparing quarterly reports on weekly literature screening outcomes; reconciling ICSRs annually for Singapore; and coordinating with partners to reconcile ICSRs for their respective countries. Additionally, pharmacovigilance training is required, and the Local Safety Officer will serve in liaison with the Pharmacovigilance Department in HQ. Submission of Product Quality Reports and Periodic Safety Update Reports is also necessary where legally required.

• A degree in Pharmacy, Biology, Chemistry, or a related field is essential.
• 3-5 years of experience in regulatory affairs, preferably in herbal or pharmaceutical products, are preferred.
• Strong attention to detail and organizational skills are crucial.

About the Role:

The primary responsibility of this position is to manage regulatory affairs and product registrations for all SciMed products.

This includes being the key point of contact for advice on regulatory guidelines and activities. Additionally, the candidate will support the Management Representative in ensuring an effective Quality Management System (QMS) and local implementation of PHC's compliance policies and ensure full adherence where necessary.

Key Responsibilities:

• Manage regulatory affairs and product registrations for all SciMed products
• Provide guidance on regulatory guidelines and activities
• SUPPORT THE MANAGEMENT REPRESENTATIVE IN ENSURING AN EFFECTIVE QUALITY MANAGEMENT SYSTEM (QMS)

Requirements:

To be successful in this role, you will need to have a strong understanding of regulatory affairs and quality management systems. You should also have excellent communication and interpersonal skills, as well as the ability to work independently and as part of a team.

Benefits:

We offer a competitive salary and benefits package, including opportunities for professional development and growth.

Why Join Us:

We are a dynamic and forward-thinking organization that values innovation and excellence. If you are a motivated and talented individual who is passionate about regulatory affairs, we would love to hear from you.