Regulatory Affairs Specialist

1 month ago

Singapur, Singapore Philips Full time
JOB DESCRIPTION

Job Title

Regulatory Affairs Specialist

Job Description

Regulatory Affairs Specialist – Singapore and Emerging Markets

In this role, you have the opportunity to

Utilize your expertise and knowledge of regulatory in developing and following–up closely the regulatory strategy and deployment within Singapore and Emerging Market

You will be part of Singapore Regulatory team and be the interface mainly of Distributors and manufacturers.

This role will be responsible for supporting of a variety of regulatory activities in Singapore and Emerging Market.

Responsibilities to ensure regulatory information management system and proper regulatory strategy and deployment for Business and marketing team and the required packages and deliverables. Capability to translate the regulatory strategy and deployment into patients needs.

You are responsible for:

Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance. Plan, generate, and coordinate regulatory submissions for product/solution licensing Maintain existing regulatory filings/ licenses, managing updates and related change control processes Assists with implementation of global regulatory and roadmaps through understanding the Competitive market landscape and product Marketing strategy. Develop regulatory strategy, and if needed connect to regulatory SME’s and make regulatory plan Proactive stakeholder management with businesses/manufacturer Develops and facilitates regulatory submissions, for new products/solution, existing products/solutions Other regulatory projects as applicable.

You are a part of:

You are part of Singapore Regulatory team. Reporting line of this position is to ASEAN RA manager. You will have exposure to a multiple business group, Philips workflow solutions and services. This position partners with business leaders, marketing, quality, and distributors where you will guide the related stakeholders in application of all applicable regulatory requirements; ensuring gap analysis, regulatory assessment and impact for a successful regulatory submission and approval in each impacted country.

To succeed in this role, you should have the following skills and experience:

Experience in ASEAN Markets Medical Device Registrations 3-5 years of experience in the medical device industry Ability to understand regulatory environment as well compliance rules, guidelines and regulations Autonomous and can do problem solving Ability to various partners in other areas/teams of Philips Experience in assembling technical documents Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape Ability to work in a matrix organization and being agile Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment

Education:

Bachelor’s Degree is required. 

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by .

To find out more about what it’s like working for Philips at a personal level, visit the on our career website, where you can read stories from our . Once there,you can also learn about our , or find answers to some of the .

  • Regulatory Affairs Senior Specialist

    2 weeks ago

    Singapur, Singapore Kenvue Full time

    Regulatory Affairs Senior SpecialistKenvue is currently recruiting for:Senior Regulatory Affairs SpecialistThis position reports into Regulatory Affairs Manager, SG, MY, BRU, and is based in Singapore.Who We AreAt Kenvue, we understand the significant impact of daily care. With a rich history and a foundation in science, we are the home of renowned brands...

  • Regulatory Affairs Specialist II

    2 weeks ago

    Singapur, Singapore Thermo Fisher Scientific Full time

    As a Regulatory Affairs Specialist within the Genetic Science Division (GSD) and Clinical Next-Generation Sequencing Division (CSD), you will have a significant impact on patients' lives and contribute to improving global health outcomes. Your expertise will be crucial in ensuring regulatory compliance and meeting all relevant requirements. Tasks and...

  • Regulatory Affairs Specialist II

    1 month ago

    Singapur, Singapore Thermo Fisher Scientific Full time

    : As a Regulatory Affairs Specialist within the Genetic Science Division (GSD) and Clinical Next-Generation Sequencing Division (CSD), you will play important role in impacting patient's life and improve global health outcome. Your expertise will contribute in maintaining the regulatory compliance of the organisation and ensuring our product meets the...

  • Regulatory Affairs Specialist II

    4 weeks ago

    Singapur, Singapore Thermo Fisher Scientific Full time

    : As a Regulatory Affairs Specialist within the Genetic Science Division (GSD) and Clinical Next-Generation Sequencing Division (CSD), you will play important role in impacting patient's life and improve global health outcome. Your expertise will contribute in maintaining the regulatory compliance of the organisation and ensuring our product meets the...

  • Regulatory Affairs Specialist

    3 days ago

    Singapur, Singapore Smith+Nephew Full time

    Regulatory Affairs Specialist based in Singapore (6 months contract) Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living. The role is responsible to ensure market access and market continuity by completing product registrations and ensuring regulatory compliance in Singapore and the Export Markets. ...

  • Regulatory Affairs Specialist

    1 month ago

    Singapur, 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...

  • Regulatory Affairs Specialist

    4 weeks ago

    Singapur, 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...

  • Regulatory Affairs Specialist

    2 months ago

    Singapur, 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...

  • Regulatory Affairs Specialist

    4 weeks ago

    Singapur, 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...

  • Regulatory Affairs

    2 weeks ago

    Singapur, Singapore Reckitt Full time

    Regulatory Affairs & Safety ManagerCity: Central SingaporeWe are ReckittHome to the world's most trusted hygiene, health, and nutrition brands. Our purpose is to protect, heal, and nurture in the continuous pursuit of a cleaner, healthier world. We are a united global team driven by this purpose. Join us in our mission to ensure that everyone has access to...

  • Regulatory Affairs Specialist, Clinical Trial Strategy and Submissions

    6 days ago

    Singapur, Singapore AbbVie Full time

    Job DescriptionDescriptionThe Regulatory Affairs Specialist is responsible for providing global regulatory expertise for Clinical Trials. They are the primary interface between global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes. The Regulatory Affairs Specialist is responsible for providing...

  • Senior / Regulatory Affairs Specialist

    2 days ago

    Singapur, 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...

  • Regulatory Affairs Specialist III

    2 weeks ago

    Singapur, Singapore Thermo Fisher Scientific Full time

    : Support and interact with Clients for the registration of Singapore site as manufacturer of sterile medicinal products for commercial/clinical use in the main markets (US, EU and ROW (Rest of the World)). Support Clients in defining the regulatory strategy for site registration. Able to write and review of CTD Module Drug Product for new Marketing...

  • 1 year contract Regulatory Affairs Specialist

    4 weeks ago

    Singapur, Singapore Recruit Express Pte Ltd Full time

    The primary function of theSenior Specialist , Regulatory Affairs (RA) is to act as the representative of the regulatory affairs organization to the JAPAC commercial organization for all aspects related to the assigned projects within the Aesthetics area. The incumbent will have knowledge of the regulatory requirements of the countries within the region....

  • Senior Regulatory Affairs Specialist

    2 days ago

    Singapur, Singapore Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Associate Consultant, Regulatory Affairs

    4 weeks ago

    Singapur, Singapore IQVIA Full time

    Responsibilities: Assist the Head of Regulatory services in assuming primary or secondary regulatory responsibility for assigned projects by providing the project team with regulatory information, guidance, training, support and strategic planning based on applicable regulations issued by the regulatory agencies across JAPAC. Deliver on regulatory...

  • Senior Specialist, Regulatory Affairs

    2 weeks ago

    Singapur, Singapore Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Senior Specialist, Regulatory Affairs

    3 weeks ago

    Singapur, Singapore Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Senior Regulatory Affairs Specialist

    5 days ago

    Singapur, Singapore Baxter Full time

    Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...

  • Regulatory Affairs

    1 month ago

    Singapur, Singapore Reckitt Full time

    Regulatory Affairs & Safety Manager City: Central Singapore We are ReckittHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to...