Regulatory Affairs Specialist
1 month ago
Regulatory Affairs Specialist â Singapore and Emerging Markets
In this role, you have the opportunity to
Utilize your expertise and knowledge of regulatory in developing and followingâup 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 SMEâs 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:
Bachelorâs Degree is required.Â
Why should you join Philips?
Working at Philips is more than a job. Itâs a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what itâs like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
-
Regulatory Affairs Specialist
1 week ago
Singapore Ethos BeathChapman Full timeJob Details:LocationSingaporeSalaryCompetitive SalaryJob TypePermanentRefBH-179384ContactRoselle CuntapayPostedabout 3 hours ago Currently recruiting for a Regulatory Affairs Specialist for a small Medical Device business. Their product is currently in a couple of markets (and doing well) but they are looking for you to get it registered in a number of other...
-
Regulatory Affairs Specialist
2 months ago
Singapore Danaher Full timeWondering 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,...
-
Regulatory Affairs Specialist
1 month ago
Singapore Philips Full timeJob TitleRegulatory Affairs SpecialistJob DescriptionRegulatory Affairs Specialist – Singapore and Emerging MarketsIn this role, you have the opportunity toUtilize your expertise and knowledge of regulatory in developing and following–up closely the regulatory strategy and deployment within Singapore and Emerging MarketYou will be part of Singapore...
-
Regulatory Affairs Specialist
1 week ago
Singapore Philips Full timeJob TitleRegulatory Affairs SpecialistJob DescriptionRegulatory Affairs Specialist – Singapore and Emerging MarketsIn this role, you have the opportunity toUtilize your expertise and knowledge of regulatory in developing and following–up closely the regulatory strategy and deployment within Singapore and Emerging MarketYou will be part of Singapore...
-
Regulatory Affairs Specialist
4 weeks ago
Singapore Philips Full timeJob TitleRegulatory Affairs SpecialistJob DescriptionRegulatory Affairs Specialist – Singapore and Emerging MarketsIn this role, you have the opportunity toUtilize your expertise and knowledge of regulatory in developing and following–up closely the regulatory strategy and deployment within Singapore and Emerging MarketYou will be part of Singapore...
-
Regulatory Affairs Specialist II
1 month ago
Singapore ThermoFisher Scientific Full timeJob DescriptionWhen you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help...
-
Regulatory Affairs Specialist II
4 weeks ago
Singapore ThermoFisher Scientific Full timeJob DescriptionWhen you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help...
-
Regulatory Affairs Specialist II
1 week ago
Singapore ThermoFisher Scientific Full timeJob DescriptionWhen you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help...
-
Senior RA Specialist
1 month ago
Singapore MERIT MEDICAL SINGAPORE PTE. LTD. Full timeRoles & ResponsibilitiesJOB TITLESenior RA Specialist / Associate ManagerDEPARTMENTRegulatory AffairsACCOUNTABILITYSenior / Regulatory Affairs ManagerDIRECTLY RESPONSIBLE FORSenior / Regulatory Affairs SpecialistJOB FUNCTION Assist the department head in managing the department activities, and as a designee during his/her absences. Tasks include but not...
-
Singapore Recruit Express Pte Ltd Full timeThe primary function of the Senior 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....
-
Regulatory Affairs Specialist
1 week ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full timeJob Description:Main Responsibilities Perform regulatory duties such as product registration, relevant lifecycle management (e.g. variation submissions) and contribute to overall regulatory strategy for assigned markets Regulatory documents and dossiers gap analysis, compilations and submission Responsible for Regulatory monitoring and analysis of new or...
-
Regulatory Affairs Specialist
1 month ago
Singapore Boston Scientific Full timeSummary 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
Singapore Boston Scientific Full timeSummary 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
4 weeks ago
Central Singapore Reckitt Full timeWe 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 the highest quality hygiene, wellness, and nourishment a...
-
Regulatory Affairs
4 weeks ago
Central Singapore Reckitt Full timeWe 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 the highest quality hygiene, wellness, and nourishment a...
-
Regulatory Affairs
1 week ago
Central Singapore Reckitt Full timeWe 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 the highest quality hygiene, wellness, and nourishment a...
-
Regulatory Affairs Specialist
1 week ago
Singapore CREDO DIAGNOSTICS BIOMEDICAL PTE. LTD. Full timeParticipate in and contribute to regulatory strategy development and planning, including identifying regulatory risks and opportunities, and developing mitigation strategies. Maintains approvals/licenses/authorizations for existing marketing authorizations. Track regulatory milestones in the internal Regulatory database and report submission status to the...
-
Head of Regulatory Affairs
1 week ago
Singapore Keller Executive Search Full timeThe 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, overseeing regulatory submissions, and liaising with regulatory bodies.Job...
-
Regulatory Affairs Associate
1 week ago
Singapore Ambition Full timeJob details:Posted 04 August 2023SalaryS$ S$66000 per annumLocationSingaporeJob type PermanentDisciplineSupply Chain & ProcurementReference267330_ Headquartered in the US with a global presence, my client is one of the specialty ingredient manufacturers supplying its products to various industries. They are looking to hire a Regulatory Affairs Associate to...
-
Head of Regulatory Affairs
1 month ago
Singapore REGASK PTE. LTD. Full timeRoles & 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,...