159 Regulatory Affairs Positions jobs in Singapore

Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.

Regulatory Affairs & QMS Manager.

Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:

Regulatory Affairs & Compliance:

• Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
• Interpret and apply global medical device regulations and standards.
• Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
• Maintain regulatory intelligence and proactively communicate changes to the organization.
• Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
• Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).

Quality Management System (QMS):

• Serve as the QMS Management Representative as required by ISO 13485.
• Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
• Lead internal audits, management reviews, and risk management activities.
• Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
• Monitor and report on QMS performance metrics and key quality indicators (KPIs).
• Ensure proper document control and change management processes are implemented.
• Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee’s understanding and compliance with quality procedures and regulatory requirements.

About the company:

• American startup with senior management team; based in US, Europe and Singapore
• Hybrid work arrangement – 2 days in office, 3 days working from home
• Excellent medical insurance coverage
• Good variable bonus structure
• Great working culture
• Excellent office location (Central – just beside MRT)

Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.

You can also contact Vincent Low for a confidential discussion at .

EA Personnel Registration No: R

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Mongkok, Kowloon, Hong Kong, North Ryde, New South Wales, Australia, Petaling Jaya, Selangor, Malaysia, Seoul, Korea, Republic of, Singapore, Singapore, Taipei City, Taiwan

Job Description:

Johnson & Johnson is seeking a Manager, Regulatory Affairs to join the Regulatory Affairs APAC team.

The Manager, Regulatory Affairs is a member of the Global Regulatory Affairs organization. The position resides in the AP Region and is responsible for working with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams and other global functions to define and implement the regional strategy for assigned products.

The position, under minimal supervision, is accountable for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements to optimize registration, and lifecycle management of marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.

This position provides regional affiliates with timely responses to Health Authority enquiries and gives general regulatory support to all affiliates in the region for the pharmaceutical sector business.

RESPONSIBILITIES:

Regulatory Strategy and Expertise

• Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up-to-date on understanding of regional/regulatory environment.
• Participates as a standing member of the project related GRT if applicable; supports the GRT by providing strategic regional input into registration and life cycle management.
• 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
• Provide regional implementation and regulatory-based advice on new and updated Core Data Sheets.
• Maintains expert knowledge in regional regulatory requirements and ensure that staff is expert in country and product-specific regulatory requirements
• Provides AP evaluation in licensing activities

Health Authority, Operating Companies, and Business Partner Interactions

Manages regulatory interactions with local operating companies and regional functions

• Serves as point of contact with local operating companies
• Ensures excellent collaborative relationship with key stakeholders including staff in the region and global R&D partners.
• Interacts with local operating companies on individual products/processes
• Facilitates discussions with local operating companies on regional or global regulatory issues, as required
• Provides guidance to local operating companies to determine timing and strategy for regional HA meetings. Participates in preparations for interactions with HAs and assist operating company with these interactions.

Regulatory Submissions

• Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).
• Ensures maintenance of generic content plans for submissions in the region, including clinical trials and registration submissions
• Coordinates and follows-up on post-approval submissions to ensure that product remains in compliance
• Reviews and provides input to critical submission documents
• Delivers on business critical regulatory submissions in accordance with development and/or post marketing priorities and timelines
• Participates in "Rapid Response Teams" to ensure appropriate and timely responses to HA questions. Provides clarification regarding HA questions and provides input to the strategy for responding to HA questions.
• Ensures tracking of submission and approval milestones
• Ensures tracking of regional post-approval commitments and ensures appropriate follow-up actions

ADDITIONAL RESPONSIBILITIES:

• Participates in the development of department processes and procedures. Ensures that defined processes are developed and implemented within the regional regulatory office to track and communicate key regulatory product activities and milestones
• Updates global regulatory staff regarding changes in regional regulatory requirements and provides support to VP, Regulatory Affairs AP as requested on initiatives.

REQUIRED TECHNICAL COMPETENCIES AND KNOWLEDGE:

Regulatory Strategy

• Good understanding of the pharmaceutical industry
• Detailed knowledge of local laws, regulations and guidance in the region related to full drug life cycle.
• Understanding of how laws, regulations and guidance apply to specific projects. Ability to interpret them and understand them in the context of the scientific and commercial environment.
• Good understanding of and experience in drug development and/or marketed products.
• Ability to anticipate and influence regulatory developments in the region and assess business impact
• Ability to communicate AP regulatory strategy to global teams and assess impact on global/regional drug development
• Understanding of the scientific and medical principles applicable to the therapeutic area and specific products.
• Awareness of pricing and reimbursement issues in AP
• Understanding of how supply chain decisions impact registrations in AP

HA and Operating Company Interactions

• Detailed knowledge of HA structures, how those agencies operate, and how and when to interact with them to generate a successful outcome.
• Ability to work with and influence HA actions and outcomes.
• Project-related knowledge of commercial/medical business needs.
• Broad understanding of scientific data (CMC, clinical and non-clinical)
• Regulatory Input into Other Functions
• Comprehensive understanding of the needs of regional business partners.

Submissions

• Detailed knowledge of laws, regulations, and guidance as they apply to submissions in the region.
• Knowledge of what is needed for dossier components and submissions, how to obtain regional components and how long it will take to gather it. Understanding of documentation requirements.
• Ability to analyze reports to determine whether they meet regulatory requirements, and are consistent with the regional regulatory strategy.

Labeling

• Knowledge of local labeling requirements.
• Under minimal supervision, and supported by a supervisor, critically review labeling development/labeling revisions and assess impact on relevant countries
• Knowledge of competitive landscape and how other companies are dealing with similar issues in labeling.
• Under minimal supervision, and supported by a supervisor, undertake labeling negotiations with health authorities

Decision Making and Problem–Solving

• Operates in a competitive, complex, and rapidly changing environment.
• Must make proposals and negotiate on prioritization and trade-offs on a project level.
• Independence on decision-making regarding regional product strategies with supervisor approval.
• Defines operational priorities and tactics in the region. Resolves conflicts in priorities in consultation with supervisor, regional business partners, and head office-based team members and other internal customers.
• Determines risk-management strategies for projects.
• Makes informed decisions by soliciting input from others where needed.
• Makes complex decisions in situations with multiple, ambiguous objectives and constraints.

Decisions and problem-solving require interpretation of applicable country-specific and company procedures, policies, standards, and regulations in drug regulation and personnel practices, but will not be explicitly circumscribed by these.

Independence/Autonomy

• Operates independently in a complex environment. Independent in daily activities, with /limited managerial oversight. Sets long-term work priorities for self in consultation with supervisor. Position makes determination of routine work issues.

KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:

• Minimum of bachelor's degree or equivalent in pharmacy or life-science or health-related discipline.
• 6-10 years of overall experience in relevant pharmaceutical industry and preferably with regulatory experience
• Hands on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements preferred. Previous experience in preparing documents for health authority submissions (Chemistry & Manufacturing, and /or Registration dossiers) also preferred.
• Demonstrated ability to handle multiple projects.
• Demonstrated organizational skills
• Ability to communicate to senior level management.
• Working knowledge of regulations in the region
• Experience in HAs interactions.
• Excellent verbal and written communication skills – proficiency in written and oral English and (Mandarin/Asian (Asia) languages is preferred.)
• Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.
• Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required
• Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
• Proficient use of technology including MS office programs and Internet resources.
• Minimal regional business travel (1 or 2 times per year) may be required. Occasional international travel may be required.
• Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones.

Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.

Regulatory Affairs & QMS Manager.

Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:

Regulatory Affairs & Compliance:

• Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
• Interpret and apply global medical device regulations and standards.
• Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
• Maintain regulatory intelligence and proactively communicate changes to the organization.
• Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
• Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).

Quality Management System (QMS):

• Serve as the QMS Management Representative as required by ISO 13485.
• Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
• Lead internal audits, management reviews, and risk management activities.
• Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
• Monitor and report on QMS performance metrics and key quality indicators (KPIs).
• Ensure proper document control and change management processes are implemented.
• Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.

About the company:

• American startup with senior management team; based in US, Europe and Singapore
• Hybrid work arrangement – 2 days in office, 3 days working from home
• Excellent medical insurance coverage
• Good variable bonus structure
• Great working culture
• Excellent office location (Central – just beside MRT)

Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.

You can also contact Vincent Low for a confidential discussion at

EA Personnel Registration No: R

• Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
• Interpret and apply global medical device regulations and standards.
• Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
• Maintain regulatory intelligence and proactively communicate changes to the organization.
• Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
• Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).

• Serve as the QMS Management Representative as required by ISO 13485.
• Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
• Lead internal audits, management reviews, and risk management activities.
• Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
• Monitor and report on QMS performance metrics and key quality indicators (KPIs).
• Ensure proper document control and change management processes are implemented.
• Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.

• American startup with senior management team; based in US, Europe and Singapore
• Hybrid work arrangement - 2 days in office, 3 days working from home
• Excellent medical insurance coverage
• Good variable bonus structure
• Great working culture
• Excellent office location (Central - just beside MRT)

Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.

Regulatory Affairs & QMS Manager.

Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:

Regulatory Affairs & Compliance:

• Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
• Interpret and apply global medical device regulations and standards.
• Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
• Maintain regulatory intelligence and proactively communicate changes to the organization.
• Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
• Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).

Quality Management System (QMS):

• Serve as the QMS Management Representative as required by ISO 13485.
• Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
• Lead internal audits, management reviews, and risk management activities.
• Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
• Monitor and report on QMS performance metrics and key quality indicators (KPIs).
• Ensure proper document control and change management processes are implemented.
• Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.

About the company:

• American startup with senior management team; based in US, Europe and Singapore
• Hybrid work arrangement – 2 days in office, 3 days working from home
• Excellent medical insurance coverage
• Good variable bonus structure
• Great working culture
• Excellent office location (Central – just beside MRT)

Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.

You can also contact Vincent Low for a confidential discussion at .

EA Personnel Registration No: R

The role will be responsible for achieving corporate objectives and effectively ensuring that agreed strategies are implemented. Accountable for all regional and local regulations for the statutory compliance of all regulatory and QA affairs activities of the Company.

A key requirement will be to balance internal hands-on execution priorities with regional strategic alignment, and at the same time, be able to navigate the current complex policy environment.

Contribute with regulatory skills to the innovation of products and services focusing on improving patient's outcome. The role requires strong understanding of the regional business environment, work in collaboration with regulatory/ Q&R team in the markets, strong interaction with corporate/manufacturing RA teams on Regulatory Affairs matters.

To represent Terumo and participate in industry associations (e.g. APACMed, MTAA, etc.) to create Terumo voice of advocacy.

Key Functions/Responsibilities

Strategic Planning:

• Developing and implementing regional regulatory strategies and processes to support the timely registration of new products, major changes and life cycle management.

• Recommend strategies to the business units on ways to resolve issues related to regulatory premarket activities and promote strong partnerships to drive

implementation and resolution.

• Represent Terumo in local or regional standards committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization

• Proactively identify market opportunities by influencing product registration, prioritizing product registration, mitigate potential regulatory approval risks based

on regulations, standards, country-specific issues or other unique characteristics

• Effectively communication between global, TAP RA to ensure implementation of

all strategic plans.

Operation Efficiency:

• Coordinate with Regulatory Affairs in the manufacturing units and CRAO and

regulatory affairs teams in the countries under the scope to ensure optimal,

efficient and compliant registration and QA reporting.

• Lead and drive RA/QA activities in accordance with local and international

requirements to ensure Terumo products are registered on time or life cycle

management in the markets are in scope of responsibility, and post marketing

surveillance risks are minimised.

• Responsible for Regulatory monitoring and analysis of new or updated local

legislation and for assuring in-time registration in the local market (country).

• Create a regulatory plan and a labelling plan (when needed) to ensure

consistency and guidance to the market introduction projects.

• Improve efficiency of entity RA teams to create a cogent process of

documents/data management / storage and / or document flow which is easy and

efficient for access to relevant stakeholders.

• Work with in-country RA teams to ensure product compliance by executing the

annual regulatory plan and reviewing all relevant compliance evidence.

• Consult with product and solutions teams to ensure timely, effective and efficient

transition to new requirements.

• Management of distributors and ensure compliance on RA&QA matters

• Encourage creation and use of automated / visual dashboards and scorecards

for as many business and function process tracks

Talent Development and Management:

• Act as a mentor and supporter to the in-country regulatory affairs team members.

• Share knowledge and guide and mentor others about regulatory best practices

and registration standards for regulatory approvals and post-market needs.

• Work with HR to actively, plan, develop and assess learning needs of key

Associates, with specific focus on current and future business needs of the

organization

• Build a personal network within the relevant talent community and take personal

accountability in attracting, developing, mentoring, retaining and growing best

regulatory affairs talent in the region

• Provide TAP/RA associates with educational programs about RA knowledge enhancement, Terumo group products, and BU marketing strategy.

• Organise yearly Asia RA meeting for development and planning of RA yearly

strategy plans.

Deliver through a hands-on management style:

• Gemba (visiting field or floor), Gembutsu (seeing actual products in R&D,

production and use), and Genjitsu (facing reality) are fundamental Terumo /

Japanese business traits. it is important for this role to demonstrate this.

• Always remain accessible and practice open management. Support teams in

execution of product requirements and registration.

Champion of Terumo culture:

• Work on establishing a close-knit, collaborative and supportive team within the

region. Understand BUs operations and priorities, work cooperatively with others

across the organization to achieve shared objectives to support business

requirements.

• Be a quality champion by viewing each issue from a "Gemba" perspective in order

to find the optimal solution. Pursue excellence in product quality, from product

supply to customer care.

• Focus efforts on continuous improvement; has a knack for identifying and seizing

opportunities for synergy and integration. Figure out the process necessary to get

things done

Education & Experience:

• Graduate or Post Graduate degree/s. (Medical / biomedical background)

• Working experience in Regulatory Affairs Medical Device (class 1, 2 and 3) is a must

• A minimum of 5 years working experience in Regulatory Affairs in APAC Team management experience.

• Proficient in Japanese and ability to transcribe dossier from Japanese to English

Key Technical/Functional Competencies:

• High level of regulatory concepts and standards

• Knowledge of product development and clinical investigation

• Highly regarded personal work ethics and character

• Talent Management. People skills extraordinaire, people empathy & compassion

• Open, inspiring and high quality communication style.

• Willingness to ask for help

• Relevant in-country & sectoral / sub-sectoral understanding (an exception can be made for a highly talented candidate)

• Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
• Interpret and apply global medical device regulations and standards.
• Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
• Maintain regulatory intelligence and proactively communicate changes to the organization.
• Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
• Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).

• Serve as the QMS Management Representative as required by ISO
• Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
• Lead internal audits, management reviews, and risk management activities.
• Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
• Monitor and report on QMS performance metrics and key quality indicators (KPIs).
• Ensure proper document control and change management processes are implemented.
• Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.

• American startup with senior management team; based in US, Europe and Singapore
• Hybrid work arrangement - 2 days in office, 3 days working from home
• Excellent medical insurance coverage
• Good variable bonus structure
• Great working culture
• Excellent office location (Central - just beside MRT)

• 1510
• SINGAPORE, Singapore
• Market Access
• APAC
• Permanent
• Hybrid

Overview

Welcome diversity and apply as you are

At Adisseo, we cherish the value of diversity whatever it may be.

By joining Adisseo, you will join committed people who make the difference every day to contribute to this challenge.

By joining Adisseo, you will integrate a dynamic international environment.

By joining Adisseo, you will discover a world full of opportunities for every stage of your career by being actor to your professional journey.

Job Title : Regulatory Affairs Specialist

We are seeking a meticulous and proactive Regulatory Affairs Specialist to ensure compliance with global regulatory requirements and support business operations. This role involves managing licenses and registrations, advising internal stakeholders, and staying ahead of regulatory changes. This role will work closely with the regional regulatory team and report functionally to Senior Regulatory Affairs Specialist. The ideal candidate will be highly organized, possess strong analytical skills, and thrive in both independent and collaborative work environments.

Responsibilities

Key Responsibilities & Duties:

Regulatory Compliance & Monitoring

• Maintain and update a centralized regulatory database to track product licenses, renewal deadlines, and compliance documents.
• Monitor regulatory updates from local country teams and assess their impact on business operations.
• Implement a tracking system to ensure timely renewals, submissions, and compliance with evolving regulations.
• Ensure proper implementation of global processes (e.g., labelling, document requests) and contribute to continuous improvement.
• Support by working with cross-functions to respond to customer audit purposes and regulatory agency queries.

License & Registration Management

• Oversee end-to-end product registrations, including dossier preparation, submission, and follow-up with regulatory agencies.
• Renew licenses for existing products, ensuring adherence to labeling, MRL (Maximum Residue Limits), and safety requirements.
• Liaise with internal teams (R&D, Quality, Legal) and external stakeholders (regulatory bodies, third-party consultants) to resolve compliance issues.
• Prepare and submit regulatory dossiers for locally manufactured dilution products (Singapore-specific).

• Coordinate with Singapore authorities (e.g., SFA, NEA) to secure necessary approvals.

• Documentation & System Maintenance

• Upload and maintain registration certificates, technical documents, and compliance records in the Product Lifecycle Management (PLM) system.

• Ensure data accuracy and completeness for audit readiness and regulatory inspections.
• Generate reports for management on registration statuses, expirations, and pending actions.
• Maintain records of formulation changes, batch records, and compliance certifications.

Stakeholder Communication & Business Support

• Advise HQ, sales, and supply chain teams on regulatory considerations for:

• New product launches (e.g., registration pathways, labeling compliance)

• Product amendments (e.g., formulation changes, claims adjustments)

• Sharing of related information from local teams (eg. updated requirements for import/export from local teams).

• Respond to customer regulatory requests, including undesirable substances declarations, safety data sheets (SDS), and supplier compliance questionnaires.
• Prepare customized compliance statements for clients based on regional regulatory requirements.
• Hold monthly alignment calls with country regulatory teams and senior regulatory affairs executive to track registration progress and address challenges.
• Support sales and supply chain teams by providing regulatory guidance for product distribution and market access.

Qualifications

Qualifications & Skills:

Education & Experience:

• Bachelor's/Master's degree in Regulatory Affairs, Chemistry, Life Sciences, or a related field.
• 2-3 years of experience in regulatory affairs, preferably in agrochemicals, pharmaceuticals, or consumer goods.
• Experience with APAC regulatory frameworks (e.g., China, India, ASEAN) is a plus.

Technical Skills:

• Proficiency in regulatory databases (e.g., PLM, SAP) and MS Office (Excel, PowerPoint).
• Knowledge of GLP, GMP, and ISO standards for compliance documentation.

Soft Skills:

• Strong attention to detail – Ensures accuracy in submissions and compliance records.
• Proactive problem-solving – Anticipates regulatory hurdles and proposes solutions.
• Excellent communication – Clearly conveys complex regulations to non-experts.
• Collaborative mindset – Works effectively with cross-functional teams.
• Results-driven – Committed to meeting KPIs (e.g., on-time renewals, audit pass rates).
• Service-oriented – Supports internal teams with a solutions-focused approach.
• Long-term thinker – Aligns regulatory strategies with business growth.