131 Regulatory Affairs jobs in Singapore

Regulatory Affairs Specialist

1 year contract, with potential to renew

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Company Description:

Our client is an American consumer health company. It is the proprietor of well-known consumer brands. They combine the power of science with meaningful human insights to empower people around the world to live healthier lives.

Summary:

Manage the regulatory activities for cosmetic products, drugs and other consumer health products, upholding both internal and external quality and compliance standards.

Key Duties & Responsibilities:

• Responsible to manage the documentation, compilation, preparation and submission of dossiers for regulatory as per Singapore requirement.
• Ensure timely submission and responsible to monitor the status with tight follow up.
• Review of products label/artwork and advertisement materials to ensure compliance to the local requirement.
• Requests, organizes, and prepares dossier documentation and related fillings to regulatory agencies under planned and approval timeline.
• Work collaboratively with internal stakeholders to deliver timely and commercially advantageous approvals and uphold regulatory compliance and marketing continuity.
• Updating product registry in all relevant internal systems and trackers.
• Assist to research on regulatory related information or updates, compile and presented to RA Manager and Senior Specialist whenever required.
• Support RA Manager with any other task as and when required

Requirements

• Degree in any Science field, with minimum 1 year of related experience
• Proficient in Microsoft Office

Interested parties, kindly click on the apply button.

Alternatively, you can share your CV at

EA License: 94C3609

Reg No: R1440247

At Gnosis by Lesaffre, we harness the power of microorganisms to transform compounds into usable nutritional actives, probiotics, and nutritional and functional yeasts that benefit human wellbeing. We strive to create a world that moves better, digests better, ages better, feels better, and ultimately, lives better thanks to microorganisms and biotransformation.

Overview

At Gnosis by Lesaffre APAC, we are looking for a talented, dynamic, and motivated Regulatory Affairs Specialist to support the expansion of our business in APAC. Reporting to the APAC Senior Regulatory Affairs Manager, you will be responsible for the regulatory compliance of our product portfolio and play a critical role providing strategic advice on regulatory risks and opportunities to support market growth and innovation in APAC.

Responsibilities

1. Ensure compliance of assigned Gnosis’ product portfolio with local regulations.
2. Manage timely regional registration activities, including registration dossier preparation and proper documentation of submitted documents.
3. Execute regional regulatory strategies in line with the global strategic plan.
4. Provide regulatory guidance and advice to internal stakeholders (e.g. marketing, R&D).
5. Conduct regulatory watch and monitor changes in local legislation landscape, assess the impact towards Gnosis’s product portfolio and communicate accordingly to internal stakeholders.
6. Build effective working relationships with internal stakeholders.
7. Work closely with regulatory colleagues to maintain knowledge in APAC countries and product-specific regulatory requirements.
8. Maintain full awareness of regulatory activities of assigned portfolio and provide regular reports.

Qualifications

1. Knowledge in food/food supplements across APAC, experience in Korean food regulations is a plus.
2. Good organizational skills, possess structured approach to working tasks.
3. Collaborative team player with the ability to work independently.
4. Experience in project management appreciated, however project management course will be offered.
5. Comfortable working in an international fast-paced environment.
6. Good written and verbal communication skills.
7. Fluent in English, Korean is a plus.

Education and experience

1. Bachelor’s degree or equivalent in Science, Pharmacy or related scientific discipline.
2. Minimum of 2 years of regulatory experience in healthcare or food industry.

Benefit and Highlights:

• Great Place to Work Certified
• Attractive Employee Benefits
• Location : Buona Vista
• Reporting : Regulatory Affairs Manager, APAC

Main Objective:

Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements. Staying abreast with regulatory compliance requirements and changes affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions.

Essential Duties and Responsibilities:

Regulatory Affairs (RA) Submissions and Applications

• Writing, preparing, submitting regulatory documents for the South-East Asia (SEA) market (Arthrex distributor and subsidiary)
• Communicating with regulators on submission projects
• Prioritising and organising multiples projects with competing priorities
• Participating in regulatory affairs planning for SEA markets
• Providing support in APAC level projects as and when needed
• Reviewing product labelling and Directions for Use (DFU), if any translation is required

RA Compliance and Document Control

• Regularly maintaining and updating product registration and listing databases for the assigned country
• Implementing change control for already-approved products including regulatory submissions
• Collecting and assessing product change information to take necessary actions

Ongoing Education and Training

• Proactively attending seminars, lectures and academic conferences to continuously develop skills and to collect and share insights

Regulatory Intelligence

• Keeping abreast with the latest regulatory updates within SEA relating to Arthrex products and ensuring Arthrex as a company is aware, ready and able to comply with the necessary changes
• Providing input to change management projects for global regulatory change assessments
• Participating and providing support in cross-functional collaboration on new product and country launches

Product Recall and Complaint Support

• Supporting product safety alert activities and field actions
• Assisting in activities relating to post market surveillance (i.e. Complaints, Performance Evaluation Reporting (PER), Adverse Event Reporting (AER), and/or liaising with Regulatory bodies in assigned countries)
• Participating in both internal and external quality system audits

Education and Experience:

• Degree qualified preferably in a Science or Engineering discipline
• Fresh graduates with strong interest in regulatory affairs are welcome to apply

Knowledge and Skill Requirements/Specialised Courses and/or Training:

• Knowledge of global regulations will be advantageous
• Excellent interpersonal skills, with proven ability to effectively communicate and form strong relationships with stakeholders across all levels
• Ability to work both independently and as part of a team to effectively contribute in both individual and collaborative settings
• Ability to manage multiple tasks and prioritize work in a dynamic, fast paced environment
• Comprehension of technical, engineering or medical terminology, and/or ability to reference literature for understanding

Interested applicants are to apply online with us!

About the Company

The client is a prominent player in the medical device industry across Asia. They are a well-established organization known for their commitment to innovation and quality, providing essential medical solutions that improve patient care. The company fosters a collaborative environment and is dedicated to maintaining the highest standards of regulatory compliance and product excellence.

About the Team | Manager

This role reports directly to the RA Manager and is a key part of the team responsible for ensuring product compliance and quality across various markets. You will work closely with internal teams, including factories and headquarters, as well as external regulatory bodies to achieve business objectives.

About the Job

As a Regulatory Affairs Specialist, you will manage all aspects of quality and regulatory compliance for medical devices. Your responsibilities include spearheading product registration, acting as the main point of contact for regulatory teams, and providing expert advice on standards and regulations. You'll also handle post-market surveillance, manage adverse events and recalls, and participate in both internal and external audits.

Skills and Experience Required

• A minimum of 2 years of experience in Regulatory Affairs within the medical device industry.
• Proven ability to coordinate and manage product registration processes.
• Experience in providing regulatory advice and interpreting guidance documents.
• A solid understanding of quality management systems, complaint handling, and post-market surveillance activities.
• Experience in conducting or participating in audits is highly preferred.
• Strong communication and interpersonal skills, with the ability to liaise effectively with various stakeholders, including local authorities.
• A proactive and meticulous approach to work, with a strong focus on compliance and quality.

If you are a dedicated professional with a background in Regulatory Affairs for medical devices and are looking to make a significant impact in a key regional role, we encourage you to apply.

To apply online , please use the 'apply' function. You may contact Putra Nur Afiq (EA: 94C3609/R22105891) directly via email or LinkedIn for more information. We regret to inform you that only shortlisted candidates will be notified.

Key Job Purpose:

• Dossier preparation & product registration submissions to HSA, leading to timely introduction of new products and responsible for supplemental filings for any changes.
• Assisting in data/information gathering & dossier compilation for product registration submission & other related licenses for SAP affiliates & distributors including progress monitoring & follow-ups.
• Provide regulatory support, update, advisory & knowledge sharing to S-Corp, 3rd party manufacturers & other manufacturers and to Sysmex affiliates & distributors in order to remain in compliance with the government regulatory requirements in Asia Pacific.

Job Responsibilities:

1. Product Registration (Local):

• Prepare & submit product registration documentation & other relevant licences' application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Singapore
• Review and edit dossier to comply with regulatory requirements
• Notify and update Health Sciences Authority (HSA) of any change of particulars / documents related to product registration
• Ensure changes to the approved products are timely submitted to authorities as required
• Ensure and maintain product approvals and licenses, including dealers etc. where applicable
• Manage Adverse Event and Field Safety Corrective Action reporting to HSA within the stipulated timeline
• Maintain product registration record and product registration database in iConnect to ensure proper documentation and record filing
• Maintain registration information in RA modules in S4& GTS and perform regulatory assessment and clearance to order blockage related to regulatory matters.
• Maintain the knowledge and awareness of current applicable regulations and standards and industry guidance in Singapore that impact the company's compliance
• Support business partners in new product registration, re-registration, renewal and amendment
• Support Sales, Marketing and SCM in all regulatory related areas
• Assisting the operational tasks as required

2. Product Registration (Regional)

• Assisting the AP affiliates & distributors in data/information gathering from manufacturers, drafting/assisting in preparation of initial dossiers for submission
• Maintain product registration records and product registration databases to ensure proper documentation and record filing for all affiliates and business partners countries
• Maintain the knowledge and awareness of current applicable regulations and standards for all affiliates and business partner countries
• Support business partners in new product registration, renewals and amendments
• Support Sales & Marketing and SCM in all regulatory related areas
• Assisting the operational tasks as required

Job Requirements:

• BSc in Medical Science or equivalent
• Min 1 years' experience in regulatory affairs including regulation research, technical documents creation and regulatory submissions.
• Medical Device Act & other medical device related regulations in Asia Pacific countries
• Fluent in English
• Knowledge of major IVD regulations/standards, at least IVD-R, ISO13485, MDSAP
• Basic computer knowledge & application, e.g. Microsoft Office, Power PDF, etc

The primary responsibility of the Regulatory Manager is to serve as a liaison between Head Quarters and Partners in Asia Pacific countries, focusing on regulatory matters. This involves coordinating queries, variations, submissions, and registrations. Key responsibilities include handling product issues or complaints, updating PDM (Product Data Management) records and Packaging records, maintaining past dossiers, recording trademarks for APAC countries, and maintaining GTIN information for products marketed in these regions.

Additionally, the Regulatory Manager will be responsible for ICSR (Individual Case Safety Report) monitoring, reporting, and documentation, recall procedures, quarterly reporting of weekly literature screening outcomes, annual reconciliation of ICSRs for Singapore, and coordination with partners to reconcile ICSRs for their respective countries. The role also includes pharmacovigilance training and serving as the Main Local Safety Officer in liaison with the Pharmacovigilance Department in HQ.

For this position, we are seeking an individual with a degree in Pharmacy, Biology, Chemistry, or a related field, and 3-5 years of experience in regulatory affairs, preferably in herbal or pharmaceutical products. A good understanding of regional health regulations and strong attention to detail and organizational skills are essential.

• Degree Requirements: Degree in Pharmacy, Biology, Chemistry, or a related field.
• Experience Requirements: 3-5 years of experience in regulatory affairs, preferably in herbal or pharmaceutical products.
• Skills and Qualifications: Good understanding of regional health regulations, strong attention to detail and organizational skills.

Join to apply for the Regulatory Affairs Specialist, APAC (1-year Contract) role at dsm-firmenich

Join to apply for the Regulatory Affairs Specialist, APAC (1-year Contract) role at dsm-firmenich

Job title – Regulatory Affairs Specialist, APAC (1-year Contract)

Location – Singapore

To provide support to Greater APAC Animal Nutrition and Health (ANH) Regulatory Affairs Team. Responsible for product registration activities, maintenance of regulatory compliance and documentation. To support internal customers (account managers, marketing team, etc) and external customers on related regulatory affairs topics.

Your Key Responsibilities

• Preparation of registration dossier for new product registration and for product renewal as per the designated countries requirements; ensuring on-time submission and on-time approval.
• Ensure proper documentation of submitted documents, utilizing in-house registration database within designated timeline.
• Create and maintain product labels as per applicable regulations.
• Montor changes in the regulatory landscape, assess the impact towards company and communicate accordingly using the in-house regulatory monitoring tools.
• Support internal and external customers queries on related topics. Provide support on regional and/or global regulatory projects. Conduct regulatory impact assessment and ingredient check assessment.
• Liaise with local regulatory authority, as necessary. Liaise with production sites, as necessary.
• Provide registration documentation support (inclusive of application of certificates) for other regions (such as EMEA, LATAM, etc).
  
  

• Unique career paths across health, nutrition and beauty – explore what drives you and get the support to make it happen.
• A chance to impact millions of consumers every day – sustainability embedded in all we do.
• A science led company, cutting edge research and creativity everywhere – from biotech breakthroughs to sustainability game-changers, you’ll work on what’s next.
• Growth that keeps up with you – you join an industry leader that will develop your expertise and leadership.
• A culture that lifts you up – with collaborative teams, shared wins, and people who cheer each other on.
• A community where your voice matters – it is essential to serve our customers well.
  
  

• University degree in biotechnology, food science, chemistry, natural life sciences or related scientific disciplines.
• Knowledge on animal nutrition industry preferred.
• Team player, organized and meticulous.
• Good communication skills.
  
  

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Legal
• Industries Chemical Manufacturing

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