-
Regulatory Affairs
6 days 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 ...
-
Regulatory Affairs
1 day 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 ...
-
Director, Regulatory Affairs
3 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 ...
-
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 ...
-
Advisor, Regulatory Affairs
6 days 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 ...
-
Regulatory Affairs Specialist
3 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 ...
-
Regulatory Affairs Associate
6 days 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 ...
-
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 ...
-
Head of Regulatory Affairs
1 day 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 ...
-
Regulatory Affairs Executive
5 days 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 ...
-
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 ...
-
Intern, Regulatory Affairs
6 days 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 ...
-
Regulatory Affairs Lead
3 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& ...
-
Regulatory Affairs Personnel
1 day 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 · - ...
-
Regulatory Affairs Manager
6 days ago
GUANGXIN ADVANCED SINGAPORE PTE. LTD. Singapore**Title Recruiting**: Regulatory Affairs Manager 境外登记主管 · **Roles & Responsibilities **角色与职责: · 1. Collect and organize the pesticide management policies and registration requirements of the target markets. · 2. Generate company-specific data (with a focus on high-quality GLP rep ...
-
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 ...
-
Regulatory Affairs Manager
3 days ago
Reeracoen Singapore Pte Ltd SingaporeOur client is a Japanese food manufacturing company. The main role of a Regulatory Affairs Manager is to handle regulations pertaining to products, such as functional ingredients, probiotics, peptides, pet foods/supplements, and infant nutrition. · This position will need to regi ...
-
Regulatory Affairs Associate
1 week ago
Kemin SingaporeOverview: · **ABOUT KEMIN** · Kemin Industries, Inc., is a global, trusted science-based company that discovers, invents, develops, manufactures and commercializes functional ingredients and feed additives for the health and nutrition industry. Headquartered in Des Moines, Iowa, ...
-
Regulatory Affairs Specialist
6 days 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 ...
-
Regulatory Affairs Executive
3 days ago
Employment Vietnam Singapore**Summary**: Our client is a UK-based multinational company specializing in the creation of original fragrances and flavors. They are seeking a talented individual to join their team as a Regulatory Affairs Executive Primary · **Responsibilities**: · - Provide technical documenta ...
Regulatory Affairs - Singapore - PHARMENG TECHNOLOGY PTE. LTD.
Description
Roles & ResponsibilitiesSingapore/Pharmaceutical Division (6-month contract)
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, preparation of submissions, required to secure regulatory approval across various therapeutic areas, in alignment with core business objectives.
Regulatory Strategy
• Prepares submission dossiers for post-approval variations within agreed timelines.
• Maintains general knowledge of latest regulatory requirements.
• Establish and maintain good working relationship with internal and external stakeholders.
• Support investigation of regulatory compliance gaps with gap remediation plan development and implementation thereafter.
• Determine regulatory relevance and perform variation assessments.
Management of Regulatory operations
• Develop and maintain regulatory database(s) as required.
• Maintain and update regulatory files and records as required.
• Ensures compliance with local regulations, corporate policies, and procedures.
• Prepares and verify monthly reports in addition to providing timely updates to relevant stakeholders.
• Receive, gather, assess, and process information received from assigned stakeholders.
• Provide administrative support where required.
Collaboration with cross-functional teams
• Support process improvements and implementation of best practices.
• Collaborates with Supply Chain Management (SCM) Team on shipment matters when required.
• Collaborates with Quality Assurance (QA) Team on Quality matters (e.g. investigation of deviations and reporting them to relevant health authorities, when applicable), and Patient Safety (PS) on safety communication when required.
• Collaborates with RA Business & Operational Excellence (BoE) on obtaining the required for regulatory submission.
Key Requirements
• Degree/Polytechnic Diploma, preferably in the Sciences (Pharmacy, Life Sciences, Biological Sciences etc)
• 1 year of experience in regulatory affairs or related work experience.
• Good knowledge and understanding of pharmaceutical & scientific processes.
• Good understanding of the regulatory environment, guidelines and processes for product registration.
• Attention to detail
• Ability to work with data and basic regulatory SOPs (learning agility and ability to learn independently/on the role will be a big plus)
• Takes ownership of tasks and strong ability to collaborate with team members
Ideal Background
Education (minimum/desirable):
BSc in health-related science, life science, Pharmacy degree desired
Languages:
English - fluent in speaking and writing.
We regret that only shortlisted applicants will be notified.
Tell employers what skills you haveNegotiation
Remediation
Regulatory Compliance
Ability To Work Independently
Process Improvement
Quality Assurance
Literacy
Regulatory Affairs
GMP
MS Office
Compliance
Medical Devices
Writing
CMC
Regulatory Requirements
Pharmaceuticals
Therapeutic Areas
Excellent Interpersonal Communication Skills
Databases
Able To Work Independently