Senior Regulatory Affairs Specialist

1 day ago


Kuala Lumpur, Kuala Lumpur, Malaysia Xcenda, LLC Full time

Xcenda, LLC is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, or disability.

Job Description

We are seeking a Senior Manager, Regulatory Affairs to join our team in Malaysia. The successful candidate will be responsible for managing the life cycle of medicinal products, ensuring compliance with Health Authority requirements.

Main Responsibilities:

  • Development of regulatory strategies for medicinal products and maintenance of product licences.
  • Compilation and submission of regulatory dossiers, including CMC/Labelling documentation.
  • Alignment with functions on variation procedures, deficiency letter, e.g., CMC, Medical Science, publishing team.
  • Management of local RA requirements (local regulatory intelligence).
  • Contact with the local Health Authority on behalf of the client.

Requirements:

  • Life Science Degree (Pharmacy degree preferable).
  • At least 5-10 years of relevant experience in Regulatory Affairs.
  • Experience in artwork management and supply strategy.
Benefits

We offer a range of benefits that support the well-being of our team members. These include benefit offerings outside the US that vary by country and will be aligned to local market practice.



  • Kuala Lumpur, Kuala Lumpur, Malaysia TIME's group Full time

    About the RoleThe Regulatory Affairs Specialist will be responsible for overseeing the entire product registration process, ensuring compliance with regulatory requirements and efficient submission of documents. Key responsibilities include strategic planning, coordination, and execution of Regulatory Affairs activities, compilation and preparation of...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Randstad Full time

    Our Organization:We are a leading multinational insurance company committed to delivering innovative insurance solutions while ensuring compliance with all relevant legal and regulatory requirements across our operations.Job Description:The Regulatory Affairs Specialist will be responsible for developing and executing the company's compliance strategy,...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Hays Recruitment Full time

    Hays Recruitment is delighted to present an exceptional opportunity for a seasoned Compliance Professional to join our client's team as a Senior Compliance Manager.The ideal candidate will have a strong background in regulatory affairs, with expertise in compliance management and governance.You will be responsible for leading the compliance program in...


  • Kuala Lumpur, Kuala Lumpur, Malaysia AmerisourceBergen Full time

    Our Regulatory Affairs department at Pharmalex, a Cencora company, is seeking a highly skilled Regulatory Affairs Senior Manager to join our team in Malaysia. This is an excellent opportunity for someone who wants to work in a dynamic and growing company and take their career to the next level.The key responsibilities of this role include managing local...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Jobstreet Malaysia Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Jobstreet Malaysia. In this role, you will be responsible for assisting clients in managing and implementing their license applications.You will utilize your analytical skills to assess risks, communicate effectively with stakeholders, and oversee financial...


  • Kuala Lumpur, Kuala Lumpur, Malaysia AmerisourceBergen Full time

    We are seeking a highly experienced Senior Manager, Regulatory Affairs to join our team in Malaysia. As a key member of our Regulatory Affairs Services team, you will be responsible for supporting change applications, dossier compilation, and content review of CMC/Labelling documentation.Key Responsibilities:Support change applications (Administrative,...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Hong Leong Group Full time

    We are looking for a highly skilled Regulatory Affairs Specialist to join our team at the Hong Leong Group. As a critical member of the MAL COM - Regulatory Compliance Department, you will be responsible for ensuring that our operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Monitor regulatory developments to...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Xcenda, LLC Full time

    Job OverviewXcenda, LLC is expanding its Regulatory Affairs Services across APAC and seeking a Senior Manager to join their team in Malaysia.Key ResponsibilitiesSupport change applications, including submission strategy, dossier compilation, and content review.Align with functions on variation procedures, deficiency letters, and regulatory...


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

    Moomoo Financial Inc. is seeking a skilled Regulatory Affairs Specialist to join our team. The successful candidate will have a strong background in risk management and compliance, with experience in supporting the Hong Kong market.Key Responsibilities:Evaluate and implement effective risk management strategies to mitigate potential threats to the...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Businesslist Full time

    Company Overview:Businesslist is a leading provider of financial services and investment management solutions. We pride ourselves on our commitment to excellence, innovation, and customer satisfaction.About the Job:We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Protech Health Sciences Full time

    To succeed in this role as a Regulatory Affair Executive, you will be responsible for ensuring compliance with Malaysian Regulations and international regulatory requirements. This involves applying and monitoring product regulatory affair matters, maintaining and updating regulatory documentation, and providing regulatory support to the R&D team.Job...


  • Kuala Lumpur, Kuala Lumpur, Malaysia BASF Full time

    Drive Compliance Excellence in Asia PacificBASF is a leading chemical company that seeks a skilled Regulatory Affairs Specialist to join its Product Safety team. This role will be based in [Location] and will report to the Regional Head of Product Safety.About the PositionProvide trade control, chemical regulations, and product stewardship services to BASF...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Be International Marketing Sdn. Bhd. Full time

    As a Regulatory Affairs Specialist at BEB International, you will play a critical role in ensuring that our business practices align with industry standards and regulatory requirements. This position requires working closely with various internal departments to manage and resolve compliance-related issues and escalations.Your key responsibilities will...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Xcenda, LLC Full time

    At Xcenda, LLC, we are expanding our Regulatory Affairs Services across APAC. We are seeking a highly experienced Senior Manager, Regulatory Affairs to join our team in Malaysia.Job OverviewThe successful candidate will be responsible for supporting change applications including submission strategy, dossier compilation, and content review of CMC/Labelling...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Pasona Full time

    Job Description: Global Regulatory Affairs ManagerPasona is looking for a seasoned Global Regulatory Affairs Manager to lead our regulatory affairs efforts worldwide. You will be responsible for managing and coordinating all aspects of regulatory compliance across various regions.Your key responsibilities will include developing and implementing global...


  • Kuala Lumpur, Kuala Lumpur, Malaysia IMU Education Full time

    At IMU Education, we are seeking a highly skilled Senior Executive, Regulatory Affairs to join our team.Key ResponsibilitiesLead the collation and verification of information required for MQA programme audit accreditation submissions.Ensure all regulatory documentation complies with MQA standards and is submitted within specified timelines.Oversee the...


  • Kuala Lumpur, Kuala Lumpur, Malaysia AmerisourceBergen Full time

    A senior manager position has become available within our Regulatory Affairs department at Pharmalex, a Cencora company. The successful candidate will be responsible for leading our Regulatory Affairs Services across APAC.The main responsibilities of this role include developing and implementing regulatory strategies, managing relationships with local health...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Reckitt Benckiser LLC Full time

    We are Reckitt, a leading global health, hygiene, and wellness company. Our purpose is to protect, heal, and nurture in the relentless pursuit of a cleaner, healthier world.About the RoleThis role offers you the chance to be the regulatory lead on pivotal projects, honing your communication skills, and nurturing robust partnerships — all while delivering...


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

    Senior Regulatory Affairs PositionThe ideal candidate will be responsible for assisting the Senior Manager in overseeing compliance efforts, working closely with stakeholders to develop and implement compliance programs aligned with legal, regulatory, and industry standards.Key Responsibilities:Assist in developing and implementing regulatory compliance...


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

    As a key member of Touch 'n Go Group's regulatory affairs team, you will play a pivotal role in ensuring the company's compliance with local and global regulations.Key Responsibilities:Develop and implement effective compliance strategies to align with company objectives and regulatory requirements.Monitor and analyse regulatory updates from relevant...