Chemill Pharma Ltd. | Regulatory

6 days ago


hong kong, Hong Kong SAR China Chemill Pharma Ltd. Full time
Regulatory / Pharmacovigilance/ Quality Assurance
  • Supervise Pharmacovigilance (PV), including submission of safety information to health authorities, literature search for safety information, PV business continuity plan, PV newcomer training, PV audit readiness, etc.
  • Implement and maintain the pharmacovigilance system to ensure compliance with local and international regulations.
  • Develop and implement regulatory strategies to ensure compliance with local and international regulations.
  • Manage regulatory submissions and communicate with health authorities to ensure timely approvals.
  • Manage Regulatory Affairs (RA), including product registration, change of particulars, preparation of tender documents, submission of periodic safety update reports, etc.
  • Conduct product quality risk assessments and develop risk management plans.
  • Lead the preparation and submission of regulatory dossiers for new products, variations, and renewals.
  • Provide regulatory guidance and support to cross-functional teams.
  • Ensure compliance with adverse event reporting requirements and manage pharmacovigilance activities.
  • Manage quality-related investigations, deviations, and CAPAs to ensure timely resolution.
  • Prepare and conduct internal and external quality audits to ensure compliance with regulatory requirements.

Requirements:

  • Bachelor's degree in pharmacy or related field. Advanced degree is a plus.
  • Minimum 3 years of experience in regulatory affairs, quality assurance, and pharmacovigilance in the pharmaceutical industry.
  • Strong knowledge of local and international regulatory requirements and guidelines.
  • Experience in managing regulatory submissions and interactions with health authorities.
  • Familiarity with GMP, GDP, and other relevant quality standards.
  • Experience in managing pharmacovigilance related regulations and adverse event reporting.
  • Strong analytical, problem-solving, and project management skills.
  • Excellent communication, interpersonal, and leadership skills.
  • Fluent in English and Chinese (Cantonese and Mandarin).
  • Ability to work independently and in a team environment.
Seniority Level

Mid-Senior Level

Employment Type

Full-time

Job Function

Legal

Industries

Pharmaceutical Manufacturing

#J-18808-Ljbffr

  • Hong Kong, Central and Western District, Hong Kong SAR China Projob21 Ltd. Full time

    Job Overview:We are seeking a highly skilled Marketing Strategist to join our team at Projob21 Ltd. as a Product Manager for the FMCG industry.About the Role:The successful candidate will be responsible for initiating and implementing marketing programs for an assigned brand, maintaining relationships with trade partners, and conducting market...


  • Hong Kong, Central and Western District, Hong Kong SAR China Projob21 Ltd. Full time

    Projob21 Ltd. is seeking an experienced Regulatory Compliance Senior Manager to join its team in North Asia.About the RoleThe successful candidate will be responsible for overseeing regulatory affairs and central compliance, ensuring that all business operations are compliant with relevant regulations.Key ResponsibilitiesOversight of Regulatory Affairs and...


  • Hong Kong, Central and Western District, Hong Kong SAR China Global Executive Consultants Ltd. Full time

    Job Title: Finance and Regulatory Reporting ProfessionalWe are seeking a highly skilled Finance and Regulatory Reporting Professional to join our team at Global Executive Consultants Ltd.


  • Hong Kong, Central and Western District, Hong Kong SAR China Ashford Benjamin Ltd Full time

    Job Title: Regulatory Compliance Expert for Asset ManagementWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Ashford Benjamin Ltd.Key Responsibilities:Provide regulatory advice to Hong Kong licensed entities and APAC fund businesses, ensuring compliance with relevant regulations and laws.Monitor and analyze regulatory...


  • Hong Kong, Central and Western District, Hong Kong SAR China Global Executive Consultants Ltd. Full time

    About the RoleAs a Strategic Regulatory Reporting Lead at Global Executive Consultants Ltd., you will play a pivotal role in ensuring the effective management of regulatory reporting processes. This position requires an individual with strong technical expertise and leadership skills to oversee various aspects of banking returns and surveys.


  • Hong Kong, Central and Western District, Hong Kong SAR China Ashford Benjamin Ltd Full time

    At Ashford Benjamin Ltd, we are seeking a highly skilled Regulatory Compliance Specialist to join our team in Hong Kong.Job SummaryWe are looking for an experienced professional to provide regulatory advice and guidance to our licensed entity and APAC fund business and control function. The successful candidate will be responsible for monitoring relevant...


  • Hong Kong, Central and Western District, Hong Kong SAR China Ashford Benjamin Ltd Full time

    **Ashford Benjamin Ltd: A Leader in Financial Services**We are seeking an experienced Regulatory Compliance Expert to join our team. This is a fantastic opportunity to work with a leading company in the financial services industry.**About the Role**The successful candidate will be responsible for overseeing and implementing regulatory compliance, trading...


  • Hong Kong, Central and Western District, Hong Kong SAR China Projob21 Ltd. Full time

    Projob21 Ltd.We represent a leading global private bank with extensive operations across 20+ locations, seeking an exceptional Regulatory & Product Compliance Director. This role is based in the dynamic North Asia region and offers a unique opportunity to make a significant impact on our organization's growth and success.About the RoleThis is a highly...

  • Compliance Expert

    4 weeks ago


    Hong Kong, Central and Western District, Hong Kong SAR China Projob21 Ltd. Full time

    Job DescriptionWe are seeking a seasoned Compliance Expert to join our team at Projob21 Ltd. This role will involve overseeing regulatory affairs and ensuring compliance with laws and regulations in the insurance sector.Responsibilities:Regulatory Compliance: Conduct regular reviews to ensure compliance with regulatory requirements and recommend enhancements...


  • Hong Kong, Central and Western District, Hong Kong SAR China Ashford Benjamin Ltd Full time

    Ashford Benjamin Ltd is seeking a highly skilled Regulatory Compliance Officer to join our team in the APAC region.Job SummaryThe successful candidate will be responsible for ensuring compliance with regulatory requirements across all aspects of our business, with a focus on Investment Research and Corporate Banking.Main Responsibilities:Providing compliance...

  • Compliance Officer

    1 month ago


    Hong Kong, Central and Western District, Hong Kong SAR China QHire Ltd Full time

    At QHire Ltd, we are seeking a highly skilled Compliance Associate/AVP to join our team.About the RoleWe are looking for a seasoned compliance professional to support our business operations and ensure that we maintain the highest standards of regulatory compliance.The successful candidate will be responsible for drafting and revising our compliance manual...


  • Hong Kong, Central and Western District, Hong Kong SAR China Global Executive Consultants Ltd. Full time

    Job DescriptionWe are seeking a highly skilled Business Regulatory Reporting Specialist to join our team at Global Executive Consultants Ltd.Job OverviewThe ideal candidate will be responsible for ensuring the accuracy and completeness of regulatory reports, maintaining effective relationships with external stakeholders, and driving process improvements in...


  • Hong Kong, Central and Western District, Hong Kong SAR China Omni Group Asia Ltd. Full time

    Omni Group Asia Ltd. is seeking a highly skilled Compliance Manager to lead our regulatory risk management efforts in Hong Kong. As a key member of our team, you will play a crucial role in ensuring the company's compliance with relevant regulations and frameworks.About the RoleWe are looking for an experienced professional with a strong background in...


  • Hong Kong, Central and Western District, Hong Kong SAR China Global Executive Consultants Ltd. Full time

    Global Executive Consultants Ltd. is seeking a seasoned Executive Regulatory Reporting Manager to join our team in Hong Kong. About the RoleWe are looking for an experienced professional to lead our regulatory reporting process, ensuring compliance with HKMA regulations and guidelines. The successful candidate will be responsible for managing various...


  • Hong Kong, Central and Western District, Hong Kong SAR China Global Executive Consultants Ltd. Full time

    Job Summary:We are seeking an experienced Senior Manager to lead our regulatory reporting team at Global Executive Consultants Ltd. in Hong Kong.The ideal candidate will have a strong background in banking and financial accounting, with expertise in regulatory reporting and managerial experience. Responsibilities include ensuring compliance with HKMA...


  • Hong Kong, Central and Western District, Hong Kong SAR China Global Executive Consultants Ltd. Full time

    Job Opportunity: We are seeking a highly skilled Senior Regulatory Reporting Manager to join our team at Global Executive Consultants Ltd. in Hong Kong.The ideal candidate will have a strong background in financial accounting and regulatory reporting, with experience in banking and financial institutions. They will be responsible for ensuring compliance with...


  • Hong Kong, Central and Western District, Hong Kong SAR China Global Executive Consultants Ltd. Full time

    Job Title: Director of Technology Regulatory ComplianceSalary: HK$90K - HK$120K per annumAbout the Role:Company OverviewGlobal Executive Consultants Ltd. is a leading recruitment agency specializing in high-caliber professionals for top-tier organizations. Our clients value our expertise in finding exceptional talent to drive business growth and success.Job...


  • Hong Kong, Central and Western District, Hong Kong SAR China QHire Ltd Full time

    Job Description:About UsQHire Ltd is a leading financial services company that requires a skilled compliance specialist to join our team.Job SummaryWe are seeking an experienced Compliance Associate/AVP who will be responsible for ensuring the company's compliance with regulatory requirements. The successful candidate will have a minimum of 3 years'...


  • Hong Kong, Central and Western District, Hong Kong SAR China Global Executive Consultants Ltd. Full time

    We are seeking a high-caliber Digital Project Coordinator to join our team at Global Executive Consultants Ltd. in Hong Kong.As a Digital Project Coordinator, you will play a crucial role in implementing digitalization projects for a financial institution, ensuring regulatory compliance and internal audit requirements are met.The ideal candidate will have a...


  • Hong Kong, Central and Western District, Hong Kong SAR China Global Executive Consultants Ltd. Full time

    Job Title: Senior ManagerCompany Overview:We are seeking a highly skilled and experienced Senior Manager to join our team at Global Executive Consultants Ltd. in Hong Kong. As a leading bank, we provide excellent career opportunities for ambitious individuals who share our passion for innovation and excellence.Salary:The successful candidate can expect a...