Regulatory Affairs Supervisor

1 week ago


Abu Dhabi, Abu Dhabi, United Arab Emirates Group 42 Full time

Overview:


G42 Healthcare is an Abu Dhabi based health technology company active across data and AI, digital health, advanced OMICS, pharma, diagnostics and environmental sciences.


Responsibilities:

  • Keep up to date with national and international legislations, guidelines and customer practices pertaining to Biobanking, stem cells and relevant guidelines
  • Liaise with, and make presentations to, regulatory authorities
  • Define public guidelines around biobanking and cord blood stem cells.
  • Work closely with Abu Dhabi Regulatory body and provide support and major input on policy and procedure implementation governing business operations, ensuring compliance with laws and regulations around Biobanking life cycle and also clearly defined regulations around the use of samples and data both by academics nationally, internationally, CROs and Pharma companies on a cost recovery basis.
  • Take the lead and support on contract negotiation with external clients requiring access to Biobank samples/data. Working closely with legal and commercial teams to develop robust package.
  • Take the lead on SLA and or MTA negotiations with external clients working closely with legal and commercial teams.
  • Review company practices and provide advice on changes to systems to reflect countrywide guidelines
  • Coordinate the technical setup of the biobank infrastructure
  • Support in the IRB and other ethics approvals for Cord Blood and Panhuman biobanks in line with UAE regulations
  • Develop the Donor consent and information leaflets for the Cord Blood and Panhuman biobanks
  • Develop and ensure the maintenance of the Standard Operating Procedures (SOPs), protocols, technical notes, guidelines and flow charts
  • Monitor, track and develop the logistics and handling of cord blood, tissue samples and Panhuman samples and data in close cooperation with third parties
  • Assist with implementation and daytoday operations of the Compliance Program, Compliance Plan, Code of Conduct, and Fraud, Waste and Abuse Plan across the enterprise while ensuring compliance with governmental requirements.
  • Identify emerging trends in compliance, anticipate the impact on processes, and proactively engage with business stakeholders to determine how to partner together to address them.
  • Assist with implementation and daytoday operations of the Compliance Program, Spearheads development and implementation of compliance policies and procedures and training programs for the National Biobank.
  • Oversee and provide direction of site visits for regulatory audits and coordinates corrective action plan, as needed.
  • Investigate and resolves compliance problems, questions, or complaints received internally or from customers/agencies.
  • Provide input and representation on key compliance initiatives, meetings, and committees.
  • Identify areas of improvement and implement new policies
  • Coordination and performance of the testing, evaluation and analysis of new functionalities, securing the continuous improvement of data and content support as well as efficient working procedures
  • Maintain a deep understanding of new and existing regulations that may impact the organization's products and processes
  • Explain regulations, procedures, and policies to all employees and stakeholders as necessary
  • Act as a liaison between the organization and state, local, federal, and international agencies to submit required forms and paperwork
  • Collect, organise, evaluate and interpret information from a number of sources
  • Support the design, implementation and execution of compliance monitoring and audit programs based on Legal and Compliance policy requirements, industry risk areas and trends and incorporate feedback and observations into existing or new policies and procedures where appropriate.
  • Support global and regional compliance projects on an asneeded basis, including support of commercial, medical, and clinical teams and activities.

Qualifications:

  • Minimum of seven years of combined experience in healthcare compliance, including current experience.
  • Must have local and international experience with regulatory compliance framework
  • Be influential and have the ability to develop national guidelines around Biobanking and cord blood stem cells
  • Strong expertise in compliance with laws, regulations, and industry codes relevant to the development of policies, procedures and commercialization of biological samples and/or data.
  • Proficiency in the Microsoft suite of tools including Outlook, Word, PowerPoint and Excel
  • Excellent interpersonal/intercultural skills
  • Working knowledge and experience with UAE regulations and FDA guidance.
  • Strong critical thinking skills, attention to detail, adaptability, and professionalism.
  • Excellent communication skills (oral and written; strong interpersonal skills in both oneonone and group settings)
  • Ability to work independently as well as collaboratively with enthusiasm and accountability.
  • Ability to work i


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Kinetic Full time

    A multinational pharmaceutical company is actively recruiting a Regulatory Affairs Supervisor to be based in Abu Dhabi, UAE.***Key aspects of the role include: Prepare and complete the registration process for assigned products. Reviewing new product submission and variation dossiers for submission. Collate and distribute all technical and regulatory...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates bp Full time

    Job Profile Summary The role is in the service of the Gas and Low Carbon Entity. It reports to the New Markets Senior Manager Hydrogen and CCS Regulatory Affairs within the Hydrogen and CCUS Regulatory Affairs team. Rapid scaleup of CCS (Carbon Capture Use and Storage) deployment is essential to meet the dual challenge of supplying the growing global demand...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Sundus Recruitment and Outsourcing Services, Abu Dhabi Full time

    Senior Regulatory Affairs Officer//Abu Dhabi Hiring the below role for one of our esteemed clients in the UAE Job Title : Senior Regulatory AffairsJob Location : Abu DhabiExperience: Atleast 6-8 years of relevant work experienceEducation : Bachelor's degreeIndustry : BankingLanguages : Arabic and EnglishSkills RequiredExemplary knowledge of the UAE...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Sundus Recruitment and Outsourcing Services, Abu Dhabi Full time

    Hiring the below role for one of our esteemed clients in the UAE .Job Title : Senior Regulatory AffairsJob Location : Abu DhabiExperience: Atleast 6-8 years of relevant work experienceEducation : Bachelor's degreeIndustry : BankingLanguages : Arabic and EnglishSkills RequiredExemplary knowledge of the UAE regulatory environment, regulatory structures, market...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Everlast Wellness Medical Center Full time

    MUST HAVE A STRONG BACKGROUND AS PHARMACISTMUST BE A ARABIC SPEAKEREssential Duties and Responsibilities Participates in the development and implementation of the regulatory strategy for therapeutic products and medical devices. Compile, prepare and submit new registration, variations, change notifications, renewals and ensure approvals in a timely manner....


  • Abu Dhabi, Abu Dhabi, United Arab Emirates abu dhabi islamic Full time

    DescriptionResearch and analyze existing and proposed laws, regulations and industry standards affecting ADX group's operations.Assess impact of regulatory changes on the ADX group's rules, policies, procedures and operations.Assist in the design and implementation of the ADX group's compliance monitoring program to assess adherence to applicable laws,...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates abu dhabi islamic Full time

    Responsibilities:Research and analyze existing and proposed laws, regulations, and industry standards affecting ADX group's operations.Assess impact of regulatory changes on the ADX group's rules, policies, procedures, and operations.Assist in the design and implementation of the ADX group's compliance monitoring program to assess adherence to applicable...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Abu Dhabi Islamic Full time

    Research and analyze existing and proposed laws, regulations and industry standards affecting ADX group's operations.Assess impact of regulatory changes on the ADX group's rules, policies, procedures and operations.Assist in the design and implementation of the ADX group's compliance monitoring program to assess adherence to applicable laws, regulations and...

  • Regulatory Manager

    1 week ago


    Abu Dhabi, Abu Dhabi, United Arab Emirates Wizz Air Full time

    Date: May 15, 2023- Company: Wizz Air Hungary Légiközlekedési Korlátolt Felelős- Location: Abu Dhabi, AE, P.O. Box 1WELCOME TO THE WORLD OF OPPORTUNITYWizz Air is a leading European low-cost airline with a fleet of modern and fuel-efficient aircraft. Our mission is to provide affordable and reliable air travel to everyone, everywhere, while minimizing...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Delivery Hero SE Full time

    Identify, monitor, analyze and report on current and future regulatory issues in all markets where talabat is active. Gather intelligence, and reports on legislative and regulatory agendas. Articulate our policy positions in briefing papers, consultation responses and internal policy meetings, as well as memos, and position papers when needed. ...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Michael page Full time

    Develop and execute a comprehensive regulatory affairs strategy aligned with the organisation's overall objectives.Analyze the impact of regulatory developments, conduct economic analysis and research, and compare similar cases in international markets to identify potential solutions.Engaging in strategic negotiations with regulatory bodies and other...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Wizz Air Full time

    Date: May 6, 2024- Company: Wizz Air Abu Dhabi LLC- Location: Abu Dhabi, AE, P.O. Box 1WELCOME TO THE WORLD OF OPPORTUNITYWizz Air is a leading European low-cost airline. Our mission is to provide affordable and reliable air travel to everyone, everywhere, while minimizing our environmental impact. We are proud to foster a diverse and inclusive team of over...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Delivery Hero SE Full time

    Identify, monitor, analyze and report on current and future regulatory issues in all markets where talabat is active.Gather intelligence, and reports on legislative and regulatory agendas.Articulate our policy positions in briefing papers, consultation responses and internal policy meetings, as well as memos, and position papers when...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Michael Page Full time

    VP Telecommunications Regulatory Strategy VPTelecommunications Regulatory StrategyDevelop and execute a comprehensive regulatory affairs strategy aligned with the organisation's overall objectives.Analyze the impact of regulatory developments, conduct economic analysis and research, and compare similar cases in international markets to identify potential...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Fortrea Full time

    Global Regulatory Submissions Manager | Fortrea Abu DhabiOur talented and diverse team of approximately 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at As a leading global contract research...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Elliott Company Full time

    Overview & ResponsibilitiesPURPOSE OF THE JOBThe Regional Legal Affairs & Compliance Attorney will be located in Abu Dhabi, reporting to the Elliott Turbomachinery Limited Abu Dhabi main office. This role manages primary daily aspects of legal and compliance matters in Abu Dhabi and the EMA region for the Ebara Elliott Energy ("EEE") Risk Management...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Abu Dhabi Global Market Full time

    Job Title: Employment Affairs CommissionerIt is envisaged that the main functions of the Employment Affairs Office will include:Raising awareness of rights and obligations under the ADGM's Employment Regulations and subordinate rules ("Regulations") Proposing amendments to the Regulations to the ADGM's legislative arm Conciliating / mediating between...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Daman - National Health Insurance Company Full time

    Role Purpose Legal Advice and other ServicesProvide timely expert legal consultation & advice on wide range of legal matters including health insurance, corporate, commercial, employment, IT, IP and International Law to management and BUs Assist on corporate and commercial matters; participate in key projects, business deals & negotiations Conduct research;...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates Dublin Health Services Management & Investment Full time

    Provide leadership and supervision to nursing staff within the operating theatre department, including Registered Nurses (RNs), Licensed Practical Nurses (LPNs), and other support staff. Assign duties, delegate responsibilities, and provide guidance and support to ensure smooth workflow and efficient operations Ensure adherence to clinical protocols,...


  • Abu Dhabi, Abu Dhabi, United Arab Emirates International Market Group for General Services Full time

    Agriculture Supervisor Job DescriptionAs an Agriculture Supervisor, your primary responsibility is to oversee the daily operations of a farm or agricultural facility. This entails a multifaceted role that combines management skills with a deep understanding of agriculture practices. It's crucial to ensure that crops and livestock are produced efficiently and...