Regulatory Affairs Manager

4 weeks ago


Singapore Recruit Express Pte Ltd Full time

Job Scope

  • Supports JAPAC RA affiliates and Global RA in Marketing Authorization (MA) and clinical development related activities for the assigned projects.
  • Manages interface with internal and external regulatory and cross-functional stakeholders, including direct/indirect interaction with regulatory agencies.
  • Implements regulatory strategies for assigned projects for countries in JAPAC region in line with area commercial priorities in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
  • Partners with intercontinental commercial, market access and medical to ensure business needs are met.
  • Represents the JAPAC regulatory function at sub-teams to present regulatory requirements or provide strategic input for the registration of products.
  • Assesses scientific data for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps.
  • Manages clinical development, clinical trial, new drug applications and lifecycle activities for the assigned projects to ensure regulatory requirements are met and optimal regulatory strategies are reached.

Requirement

  • Min Bachelor in pharmacy
  • Minimum 5 years' of regulatory experience in pharma industry

Basic salary: $7K to $8K

Interested applicants, please email your updated CV to [HIDDEN TEXT]

Consultant: Huang Jingsheng Kevyn (R1333338)

Recruit Express Pte Ltd (99C4599)


  • Regulatory Affairs

    2 days ago


    Singapore MEAD JOHNSON NUTRITION (SINGAPORE) PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibilities: Assist Regulatory Affairs Director in providing regulatory activities and product safety support for Reckitt products (Health, Nutrition and Hygiene category). Lead the on-going regulatory compliance, notification, and registration of Reckitt products. Lead and co-ordinate the resolution of regulatory including...

  • Regulatory Affairs

    1 week ago


    Singapore Mead Johnson Nutrition (singapore) Pte. Ltd. Full time

    Responsibilities:Assist Regulatory Affairs Director in providing regulatory activities and product safety support for Reckitt products (Health, Nutrition and Hygiene category).Lead the on-going regulatory compliance, notification, and registration of Reckitt products.Lead and co-ordinate the resolution of regulatory including Code of Ethics movement,...


  • Singapore ACCESS-2-HEALTHCARE Full time

    Roles & ResponsibilitiesCompany DescriptionAccess-2-Healthcare is a global consulting company dedicated to helping small to medium sized medical technology organizations overcome various challenges and launch their products in the market. Founded in 2015, the company has local offices in 14 countries and is dedicated to getting the job done by providing...


  • Singapore REGASK PTE. LTD. Full time

    Roles & ResponsibilitiesOUR COMPANYWe, 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 diverse with more than 10 nationalities across 3 continents,...


  • Singapore REGASK PTE. LTD. Full time

    Roles & ResponsibilitiesOUR COMPANYWe, 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 diverse with more than 10 nationalities across 3 continents,...


  • Singapore Access-2-healthcare Full time

    Company DescriptionAccess-2-Healthcare is a global consulting company dedicated to helping small to medium sized medical technology organizations overcome various challenges and launch their products in the market. Founded in 2015, the company has local offices in 14 countries and is dedicated to getting the job done by providing expertise to doctors,...


  • Singapore RXILIENT MEDICAL PTE. LTD. Full time

    Roles & ResponsibilitiesPosition: Vice President, Regulatory AffairsGeographical Focus: Southeast Asia and Taiwan, expanding to the MENA marketResponsibilities: Lead the oversight of regulatory projects from inception to completion within the assigned portfolio, ensuring deep understanding and application of regulatory strategies in the Asia Pacific and...


  • Singapore LABGISTICS ASIA PTE. LTD. Full time

    Roles & ResponsibilitiesThis role is part of LABGISTICS Asia Pte Ltd's (LABG) Quality and Regulatory Affairs (QRA) department under the Commercial Support Services Division. The job holder will provide strategic direction and alignment for the Regulatory Affairs (RA) function, working closely with Quality Assurance (QA) function to ensure compliance at our...


  • Singapore ADVANCED OPHTHALMIC INNOVATIONS PTE. LTD. Full time

    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...


  • Singapore Rxilient Medical Pte. Ltd. Full time

    Position: Vice President, Regulatory AffairsGeographical Focus: Southeast Asia and Taiwan, expanding to the MENA marketResponsibilities:Lead the oversight of regulatory projects from inception to completion within the assigned portfolio, ensuring deep understanding and application of regulatory strategies in the Asia Pacific and future global markets.Craft...


  • Singapore OCULUS PRIVATE LIMITED Full time

    Roles & ResponsibilitiesResponsibilities: Prepare product technical dossiers for regulatory submission Understand labelling requirements in multiple region and manage artwork used in product packaging Liaise with relevant parties to resolve product registration and regulatory issues Maintain document control of technical file, quality procedures and work...


  • Singapore Advanced Ophthalmic Innovations Pte. Ltd. Full time

    . 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...


  • Singapore Danaher Full time

    Wondering what's within Beckman Coulter Diagnostics? Take a closer look.At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds,...


  • Singapore BASF SE Full time

    Objectives of the PositionReporting to the global Vice President Seeds and Traits Regulatory Affairs, this role is a key member of the global Regulatory, Sustainability & Public Affairs leadership community, working closely with peers, and the Senior Vice President for Regulatory, Sustainability and & Public Affairs. It also serves as a member of the...


  • Singapore LABGISTICS ASIA PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibilities: Lead and supervise the SG Regulatory Affairs (RA) Accountable for all permit & licenses application, renewals, and maintenance under the company Accountable for all Products Registration, renewals, and amendments Guide and train the Regional Regulatory Affairs team on the preparation of documents for license...


  • Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    Roles & ResponsibilitiesAs a Regulatory Affairs Manager, your primary responsibility will be to lead submission processes and streamline regulatory procedures to secure product approvals across the APAC/Asia/ASEAN markets. Moreover, you will be tasked with fostering collaboration and ensuring compliance with regional regulations.Role Overview Lead the...


  • Singapore Boston Scientific Full time

    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’ personnel in order to expedite approval of pending registration and answers any questions on product documentation.  Provide management team...


  • Singapore Oculus Private Limited Full time

    Responsibilities:Prepare product technical dossiers for regulatory submissionUnderstand labelling requirements in multiple region and manage artwork used in product packagingLiaise with relevant parties to resolve product registration and regulatory issuesMaintain document control of technical file, quality procedures and work instructions for the purpose of...

  • Quality Assurance

    1 month ago


    Singapore VIVO SURGICAL PRIVATE Full time

    About UsVivo Surgical is Southeast Asia’s pioneering surgical technology disruptor, engaged in developing innovative medical device solutions for better surgeries. An ISO 13485 certified company with international accreditations such as the US FDA and EU CE Mark, our products target the medical needs of the world through innovative applications of science...


  • Singapore Integrity Partners Pte. Ltd. Full time

    As a Regulatory Affairs Manager, your primary responsibility will be to lead submission processes and streamline regulatory procedures to secure product approvals across the APAC/Asia/ASEAN markets. Moreover, you will be tasked with fostering collaboration and ensuring compliance with regional regulations.Role OverviewLead the coordination of submission...