Regulatory Affairs Supervisor

5 days ago

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
- Co-ordinate the technical setup of the biobank infrastructure
- Support in the IRB and other ethics approvals for Cord Blood and Pan-human biobanks in line with UAE regulations
- Develop the Donor consent and information leaflets for the Cord Blood and Pan-human 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 Pan-human samples and data in close cooperation with third parties
- Assist with implementation and day-to-day 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 day-to-day 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
- Co-ordination 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 as-needed 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 one-on-one and group settings)
- Ability to work independently as well as collaboratively with enthusiasm and accountability.
- Ability to work i

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