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Regulatory Affairs
1 week ago
PHARMENG TECHNOLOGY PTE. LTD. SingaporeSingapore/Pharmaceutical Division · **Job Purpose** · To contribute as an integral member of Client's Singapore RA team to support all regulatory activities for Client's products. This includes the development and implementation of regulatory strategies, including the review, pre ...
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Regulatory Affairs
3 days ago
Kemin SingaporeOverview: · LI-KT1 · **Responsibilities**: · - Manage and coordinate research projects and work with project team toprepare project plan, budget and timelines. · - Oversee project progress, ensure project execution and completion to meet setcriteria and product quality, within al ...
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Regulatory Affairs Manager
5 hours ago
RECRUITPEDIA PTE. LTD. Singapore**Our client is a Swedish MNC, one of the leading players in the F&B Manufacturing. Due to business needs, they are now recruiting a Regulatory Affairs Manager to be part of their Regulatory Affairs team for ongoing transformation projects. They are located in the North - easily ...
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Regulatory Affairs Specialist
5 days ago
Johnson & Johnson SingaporeCaring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Joh ...
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Advisor, Regulatory Affairs
1 week ago
Kimberly-Clark SingaporeThe GRA **Advisor, Regulatory Affairs - APAC** provides vision, direction, and advice in the implementation of APAC regulatory strategies to ensure regional management of Consumer, Professional or enterprise innovation level regulatory compliance. The incumbent will strategize wi ...
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Regulatory Affairs Manager
1 week ago
DSM-Firmenich SingaporeCOMPANY DESCRIPTION · As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world's growing population to thrive. With our comprehensive range of solutions, with natural and renewable i ...
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Director, Regulatory Affairs
5 days ago
Kimberly-Clark SingaporeThe** **Director, Regulatory Affairs - APAC K-C Professional (KCP) & Consumer** **leads the regional regulatory affairs team for APAC (Asia-Pacific, Australia & China), and is responsible for establishing, implementing and maintaining required regulatory compliance for the busine ...
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Head of Regulatory Affairs
4 days ago
REGASK PTE. LTD. Singapore**OUR COMPANY** · We, at RegASK are a high growth global RegTech company leveraging technology and global network of experts to revolutionize regulatory intelligence, serving the LifeSciences (MedTech, CROs, Pharma) and FMCG industries (Food, Personal Care). RegASK team is highly ...
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Regulatory Affairs Executive
1 week ago
RECRUITPEDIA PTE. LTD. Singapore**Our client is an established company specialising in Biomedical and Manufacturing. They are expanding and growing at a fast pace and now looking to hire a Regulatory Affairs (RA) Executive to support the growth. They are located in the West - easily accessible. · The Duties of ...
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Head of Regulatory Affairs
1 week ago
Keller Executive Search SingaporeThe Head of Regulatory Affairs will be responsible for ensuring that our company complies with all relevant regulations and laws. This role requires a deep understanding of the pharmaceutical industry's regulatory environment and involves developing regulatory strategies, oversee ...
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Regulatory Affairs Specialist
1 day ago
Boston Scientific Corporation Singapore**Work mode**:Hybrid**Onsite Location(s)**:Singapore, 01, SG**Summary** · Ensures rapid and timely approvals for respective product line by plans on all product registrations, manage all product registrations' preparation and documentation. Interacts with regulatory agencies' per ...
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Regulatory Affairs Associate
1 week ago
Ambition Singapore**Job details**: · Posted 04 August 2023 · SalaryS$ S$66000 per annum · LocationSingapore · Job type Permanent · DisciplineSupply Chain & Procurement · Reference267330_ · Headquartered in the US with a global presence, my client is one of the specialty ingredient manufacturers s ...
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Regulatory Affairs Intern
1 week ago
Food Industry Asia (FIA) Singapore**REGULATORY AND PUBLIC AFFAIRS INTERN · **What to expect**: · The **Regulatory and Public Affairs Intern **will provide support to the organisation and its Committees. Reporting to Leadership Team, this role will support the team to achieve FIA's ambition of being the leading or ...
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Intern, Regulatory Affairs
1 week ago
Kyowa Kirin Asia Pacific Pte. Ltd. SingaporeCompany · Kyowa Kirin Asia Pacific Pte. Ltd. · Designation · Intern, Regulatory Affairs · Date Listed · 17 Mar 2023 · Job Type · Entry Level / Junior Executive · - Intern/TS · Job Period · From May 2023, For At Least 6 Months · Profession · Others / General Work · Industry · Manu ...
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Regulatory Affairs Lead
6 days ago
ACCESS PEOPLE (SINGAPORE) PTE. LTD. Singapore**Position Overview**: · **Key Responsibilities**: · - Develop and execute regulatory strategies for product development, registration, and lifecycle management in compliance with regional and global regulations. · - Collaborate cross-functionally with internal teams including R& ...
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Regulatory Affairs Specialist
1 day ago
TALENTSIS PTE. LTD. Singapore**Responsibilities**: · - Assess regulatory requirements and discuss regulatory strategies with the related staff for the qualifications of new products in Asia Pacific. · - Compile technical files, test reports and documentations necessary for regulatory submissions in the above ...
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Vp, Regulatory Affairs
1 week ago
RXILIENT HEALTH PTE. LTD. Singapore**Position**: Vice President, Regulatory Affairs · **Geographical Focus**: Southeast Asia and Taiwan, expanding to the MENA market · **Key Responsibiliites**: · - Craft and execute regulatory program strategies to ensure efficient submission planning and execution, with a keen fo ...
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Regulatory Affairs Manager
1 day ago
NUSANTARA PRIME CONSULTING PTE LTD Singapore**Responsibilities**: · - Ensures legal compliance of company products and the activities with local guidelines and codes (including but not limited to product naming, labelling, packaging design, product selling point and advertising/promotion materials) · - Help in the preparat ...
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Regulatory Affairs Personnel
3 days ago
HAATON CAPITAL PTE. LTD. SingaporeThe Regulatory Affairs (RA) Personnel contributes to the regulatory function by registering, attaining and maintaining marketing authorisation of therapeutic products. · Key Responsibilities · - Prepare and review registration dossiers for submission to drug regulatory agency · - ...
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Regulatory Affairs Specialist
1 week ago
Johnson & Johnson Singapore*** · The Regulatory Affairs Specialist has the responsibility to Supports regulatory department to ensure efficient and compliant business processes and environment. Assists in the registration of new products/changes/renewal licenses by preparing documentation needed for regist ...
Assistant Manager, Clinical and Regulatory Affairs - Singapur, Singapore - ADVANCED OPHTHALMIC INNOVATIONS PTE. LTD.
5 days ago
Description
Roles & Responsibilities· Responsible for activities related to the Company's regulatory management systems, including coordinating, training, developing, improving, and implementing existing and new regulatory pathways.
· Prepares, submits, tracks, indexes and archives electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and marketing materials.
· Responsible for helping to develop and manage international product registrations, including working with the market access team to respond to requests for information, and liaise with the distributors.
· Preparing and maintaining product registration database.
· Coordinate in document legalization to support international regulatory submissions.
· Support cross functional team by contributing actively to the Clinical Evaluation Report with regular updates of the Summary of Safety and Clinical Performance, literature search, risk analysis, vigilance reporting and post-market clinical follow-up, periodic safety update reports, and post-market surveillance reports in a timely manner.
· Maintain and organize regulatory affairs files and documentation.
· Assist in implementing department procedures and provide support to Clinical and Regulatory Affairs team.
· Maintain ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file system.
Tell employers what skills you haveFDA
Regulatory Compliance
Regulatory Affairs
ISO
Surveillance
Medical Devices
Vigilance
Team Player
Life Sciences
Regulatory Submissions
work well in team environment