Associate Consultant, Regulatory Affairs

1 week ago


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 projects in a timely and proactive manner. Manage projects by coordinating with incountry regulatory team leads.
  • Identify and interpret regulations, guidelines, and other pertinent information issued by the applicable regulatory agencies and other regulatory organizations.
  • Review scientific data, publications, and related papers, as appropriate for various regulatory projects to ensure compliance with regulations. (Strategic guidance, dossiers preparation, submission activities & etc.)
  • Develop effective product registration strategies by performing critical review and gap analysis of product documentation.
  • Establish relationships with regulatory agencies, health bodies, internal and external stakeholders.
  • Ensure revenue is recognized by managing professional activities and internal stakeholders' finances allocation.
  • Deliver training workshops and regulatory webinar to internal and external stakeholders.
  • Assist in identifying business opportunities for regulatory projects.

Requirements:

yrs of regulatory affairs experience

  • Demonstrate comprehensive regulatory affairs expertise. aptitude for activities related to regulatory affairs and quality compliance for products market access and maintenance.
  • Familiarity with regulatory documents, general contents and the methods of filing and tracking.
  • Good interpersonal and negotiating skills, with an ability to identify and resolve issues efficiently and effectively.
  • Ability to read/synthesize technical materials and prepare clear/concise written documents.
  • Ability to juggle competing priorities to meet deadlines while maintaining high quality work.


  • Singapore Ambition Full time

    Job 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...


  • Singapore Ethos BeathChapman Full time

    Job Details:LocationSingaporeSalaryCompetitive SalaryJob TypePermanentRefBH-178593ContactPiers Atkinson- Postedabout 1 hour ago A new entrant to Asia, this Biopharma is looking for a Regulatory Affairs Associate Director. You will be in charge of all things regulatory in APAC where currently they don't have anything, so you will be able to set things up how...


  • Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    Headquartered:US:- Position: Regional:- Product Porfolio:Medical Devices:- Reporting to: Regulatory Affairs ManagerMAIN RESPONSIBILITIES: Facilitate regulatory affairs activities related to regulatory submissions, annual reports, registrations, and listings while ensuring compliance with relevant medical device regulations, guidances, and standards in...

  • Regulatory Affairs

    1 month 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

    4 weeks ago


    Central Singapore Reckitt Full time

    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 the highest quality hygiene, wellness, and nourishment a...

  • Regulatory Affairs

    4 weeks ago


    Central Singapore Reckitt Full time

    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 the highest quality hygiene, wellness, and nourishment a...

  • Regulatory Affairs

    1 week ago


    Central Singapore Reckitt Full time

    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 the highest quality hygiene, wellness, and nourishment a...


  • 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,...

  • Senior RA Specialist

    1 month ago


    Singapore MERIT MEDICAL SINGAPORE PTE. LTD. Full time

    Roles & 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 PHARMENG TECHNOLOGY PTE. LTD. Full time

    Roles & ResponsibilitiesPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world...


  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Roles & ResponsibilitiesPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world...


  • 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 Takeda Pharmaceutical Full time

    JOB SUMMARYThe job requires the person to manage Regulatory Affairs for all Company products to ensure they are in compliance with statutory and company requirements and maximize the contribution of Regulatory Affairs to the achievement of business objectives through active assistance in the development and implementation of the company's policy positions...


  • Singapore LOTUS INTERNATIONAL PTE. LTD. Full time

    The individual Contributor will be based in the Singapore office and is responsible for working with Global Regulatory Teams and head office-based team members (e.g. Business Development Team) to define and implement country-specific regulatory strategy for assigned products. This incumbent will report remotely to the Distribution Regulatory Affairs...


  • Singapore Kemin Full time

    Overview:ABOUT KEMINKemin 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, with a vision to "sustainably transform the quality of life every day for 80 percent of...


  • Singapore Prudential plc Full time

    Regulatory Affairs InternPrudential's purpose is to be partners for every life and protectors for every future. Our purpose encourages everything we do by creating a culture in which diversity is celebrated and inclusion assured, for our people, customers, and partners. We provide a platform for our people to do their best work and make an impact to the...


  • Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    Job 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...


  • Singapore Prudential plc Full time

    Prudential's purpose is to help people get the most out of life. We will deliver our purpose by creating a culture in which diversity is celebrated and inclusion assured, for our colleagues, customers, and partners. We provide a platform for our people to do their best work and make an impact to the business, and in exchange, we support our people's career...


  • Singapore Keller Executive Search Full time

    The 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...


  • Singapore Ethos BeathChapman Full time

    Job 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...