Specialist, Regulatory Affairs

3 weeks ago


Kuala Lumpur, Malaysia Organon Full time

**Responsibilities**:
The Specialist is responsible for all PV and RA submission requirements and PV activities for their assigned product portfolio as applicable (medical device and pharmaceutical products.

The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.

The Specialist is also responsible for other activities (as delegated/assigned by their manager) which may include but are not limited to: review of local PV and RA agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, authoring/reviewing SOPs, training, communication of safety issues, developing product registration plans and strategies.

**Secondary Job Description**

**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

**Search Firm Representatives Please Read Carefully**

**Annualized Salary Range**

**Annualized Salary Range (Global)**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites**

**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R524187



  • Kuala Lumpur, Malaysia Zoll Medical Corporation Full time

    **Regulatory Affairs Specialist**: **Location: Remote, Remote**: **Circulation**: At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Moomoo Financial Inc. Full time

    About the RoleAs a Regulatory Affairs Specialist, you will play a crucial role in ensuring our compliance with regulatory requirements.Responsibilities:Compliance Reporting: Prepare and submit regular compliance reports highlighting identified compliance issues and recommended actions.Training and Education: Provide compliance training to employees to foster...


  • Kuala Lumpur, Malaysia ZOLL LifeVest Full time

    **Location: Remote, Remote**: **Circulation**: At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Edwards Lifesciences Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Edwards Lifesciences. The ideal candidate will have experience in planning and implementing regulatory process improvement projects, working with stakeholders across various business units, and ensuring compliance with regulatory requirements.Key...


  • Kuala Lumpur, Malaysia QIAGEN Full time

    At the heart of QIAGEN’s business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. Our...


  • Kuala Lumpur, Malaysia Qiagen Full time

    **Overview** At the heart of QIAGEN’s business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Touch 'n Go Group Full time

    Job OverviewThe Manager, Regulatory Affairs will play a crucial role in overseeing the company's compliance efforts. This includes developing and implementing compliance programs aligned with legal, regulatory, and industry standards.


  • Kuala Lumpur, Malaysia HSBC Full time

    **Some careers have more impact than others.** If you’re looking for a role where you can continue to make an impression, take the next step at HSBC where your contributions will always be valued. HSBC is one of the largest banking and financial services organisations in the world, with operations in 64 countries and territories. We aim to be where the...


  • Kuala Lumpur, Malaysia Organon Full time

    **Responsibilities**: The Specialist is responsible for all PV and RA submission requirements and PV activities for their assigned product portfolio as applicable (medical device and pharmaceutical products. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting...


  • Kuala Lumpur, Malaysia Medtronic Full time

    **Careers That Change Lives **We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Quality & Regulatory Affairs and help shape policies that change lives. Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and...


  • Kuala Lumpur, Malaysia BD Full time

    **Job Description Summary**: We are **the makers of possible** BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Hays Recruiting MY Full time

    Role Summary:The Regulatory Affairs Coordinator will be responsible for managing licenses, permits, and certifications to ensure compliance with regulations. This includes negotiating with authorities and stakeholders, maintaining accurate records, and collaborating with cross-functional teams. If you are a detail-oriented individual with a passion for...


  • Kuala Lumpur, Malaysia DKSH Full time

    **Location**:Kuala Lumpur, MY, MY**Job Summary** Supervise the execution of company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and regulations **General Responsibilities** - Support superior in managing day-to-day operating...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Businesslist Full time

    RequirementsExperience: A minimum of 8 years of professional experience in government relations or affairs, preferably with a background in engaging government ministries related to transportation, public works, consumer affairs, and other regulatory agencies.Expertise: Demonstrated expertise in stakeholder management, with the ability to collaborate...


  • Kuala Lumpur, Malaysia BI (Malaysia) Sdn. Bhd Full time

    **The Position**: - To achieve timely & successful product registrations in accordance with corporate & local strategies. - To update the Company on new Regulations and Guidelines, and to ensure the Company complies with the local legislations & industry codes governing the import and control of therapeutic products. - To ensure compliance with Company...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Thermo Fisher Scientific Full time

    About the JobWe are seeking a Regulatory Affairs Associate to join our team at Thermo Fisher Scientific. In this role, you will be responsible for ensuring the regulatory compliance of our import and export activities in accordance with company good practices and client requirements.Key Responsibilities- Qualified Pharmacist to act as Importer of Record...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Ant International Full time

    Regulatory Affairs ProfessionalWe are seeking a highly skilled Regulatory Affairs Professional to join our team at Ant International. In this role, you will be responsible for ensuring the effectiveness and efficiency of our internal privacy products, as well as promoting our products and services to targeted internal users.You will work closely with...


  • Kuala Lumpur, Malaysia Novonesis Full time

    **Location**: Malaysia : Kuala Lumpur **Country**: Malaysia**Our purpose points the way** In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago, this has been our guide. It’s how we've gotten so far. And it’s how we'll impact the future. Now, more than ever, the world...


  • Kuala Lumpur, Malaysia NuFarm Full time

    Regulatory Affair Executive/ Manager Support Registration of Few Countries in SOUTHEAST Asia Grow a Better Tomorrow with Nufarm. Nufarm is the dependable partner behind thousands of agricultural success stories. Every day, growers around the world turn to our products and our people to help with the challenges of fighting disease, weeds, and pests, and...

  • Quality Assurance

    2 weeks ago


    Kuala Lumpur, Malaysia Recruit Express Full time

    **Principal Function** As a Quality Assurance (QA) and Regulatory Affairs (RA) Executive, you will play a key role in ensuring compliance with relevant regulatory requirements and maintaining the highest standards of quality across our organization. You will collaborate closely with cross-functional teams to implement and maintain quality management systems...