Summary
Overview
Work History
Education
Skills
Timeline
Generic
Maria Briana

Maria Briana

Research Management, Governance, Compliance, Regulatory Submissions, Manager
London, UK

Summary

Regulatory affairs professional with comprehensive experience in navigating complex regulatory landscapes and ensuring compliance. Strong focus on team collaboration and achieving results, with adaptable approach to changing needs. Skilled in regulatory strategy, risk assessment, and policy development. Valued for reliability, analytical mindset, and effective communication in high-stakes environments.

I am dedicated, compassionate and heavily involved in local community initiatives that works inline with improving people’s health and wellbeing through offering dynamic research skills within health organizations.

My hardworking and passionate spirit makes me a great job seeker ready to positively impact my skills towards achieving a better health system and good health for all.

Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.


Results-oriented achiever with proven ability to exceed targets and drive success in fast-paced environments. Combines strategic thinking with hands-on experience to deliver impactful solutions and enhance organizational performance.

Overview

25
25
years of professional experience
1
1
Language

Work History

Research Governance Compliance Regulatory Manager

Barts Health NHS, Queen Mary University of London
01.2020 - Current
  • Enhanced regulatory compliance by developing and implementing effective policies and procedures.
  • Established monitoring systems for tracking progress towards key performance indicators related to regulatory affairs activities.
  • Provided expert guidance for navigating complex regulations, leading to successful product approvals.
  • Implemented training programs to increase staff awareness of regulatory requirements and best practices.
  • Simplified complex regulations into actionable tasks, enabling greater efficiency in achieving compliance goals.
  • Actively participated in industry associations, staying current on emerging trends and changes in the regulatory landscape.
  • Mentored junior staff members, fostering talent development within the regulatory department.
  • Managed a successful audit, addressing all findings and implementing corrective actions in a timely manner.
  • Reduced risk exposure by proactively identifying potential compliance gaps and initiating appropriate measures.
  • Negotiated favorable terms on consent agreements, minimizing company liability while maintaining good standing with regulators.
  • Contributed significantly to the organization''s reputation for regulatory excellence by maintaining a strong track record of compliance and successful audits.
  • Championed a culture of compliance by regularly communicating expectations and progress updates to internal stakeholders.
  • Drove continuous improvement initiatives within the department by analyzing processes, identifying opportunities for optimization, and implementing best practices.
  • Conducted thorough reviews of technical documentation to ensure alignment with regulatory standards.
  • Streamlined the permit approval process for faster project completion and reduced costs.
  • Collaborated with cross-functional teams to ensure seamless integration of regulatory requirements throughout product development.
  • Developed strategies to maintain ongoing compliance as new regulations were introduced or updated, ensuring continuous adaptability.
  • Supported business growth through strategic input on potential acquisitions or partnerships from a regulatory perspective.
  • Coordinated responses to inquiries from regulators or other external parties, ensuring accurate information was provided in a timely manner.
  • Prioritized project-related tasks to efficiently complete essential tasks.
  • Performed and documented quality control checks to maintain compliance with company initiatives.
  • Worked with governance committees to make and evaluate plans.
  • Recommended improvements to processes.
  • Prepared and maintained document inventory for core dossier preparation.
  • Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
  • Provided responses to regulatory agencies regarding product information or issues.
  • Consulted with regulatory representatives to manage filings, applications, and reports.
  • Analyzed field studies and reports, compiled information and submitted concise and informative summaries.
  • Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
  • Devised and deployed techniques for obtaining earliest possible approval for each product.
  • Directed documentation efforts to comply with domestic and international regulations and standards.

Senior Research Management and Governance Officer

Imperial College London
01.2000 - 01.2020
  • Safeguarded confidential data through strict implementation of privacy policies across all departments.
  • Promoted transparency within the organization through clear documentation, communication, and reporting practices.
  • Monitored industry trends and regulatory changes to proactively adapt governance practices as necessary.
  • Managed own work assignments under general supervision to complete self-assessments and other assigned reviews and projects.
  • Research support, governance and compliance. Project management of portfolio of studies, amendments, training delivery, presentations. Reporting and accurate recording of data input. Audits and monitoring. Sponsorship reviews for studies, clinical trials, amendments. Help and support with REC, MHRA and REC submissions. NIHR GCP training to researchers and training new staff. Managing and dealing with line management, clear communication. Providing support as and when required by line management. Continuous development. Work across all research themes and support across all Trust sites. Ability to work under pressure. Achieving deadlines and targets on a continuous basis. Deputising and covering for members of staff who may be absent from work. Flexible and reliable approach to work and continuous self improvement, training and education. Undertaking study feasibility and assisting with costings and contracts. Putting in place new procedures and processes for a streamlined approach and for ensuring due diligence.
  • Managed conflicts of interest by establishing clear guidelines on disclosure requirements and appropriate actions for resolution.
  • Facilitated the development of effective committee structures for improved efficiency in decision-making processes.
  • Improved governance processes by implementing comprehensive risk management strategies.
  • Oversaw compliance initiatives, working closely with legal counsel to mitigate potential risks associated with non-compliance issues.
  • Conducted comprehensive audits of internal controls to identify areas for improvement in risk mitigation strategies.
  • Facilitated conference calls and meetings with various team members and business partners for work assignments.
  • Developed and maintained organizational policies for enhanced compliance with regulatory requirements.
  • Contributed to a culture of continuous improvement by regularly reviewing and updating governance frameworks.
  • Prepared and distributed assessment reports and conducted closing conferences with various business partners.
  • Managed stakeholder relationships to maintain open communication channels and facilitate collaboration on governance matters.
  • Assisted in developing and maintaining department policies and procedures to support organization and industry best practices.
  • Ensured adherence to corporate social responsibility commitments by monitoring performance against established targets.
  • Compiled data for analysis and developed tracking and reporting.
  • Streamlined reporting processes to ensure timely, accurate, and relevant information for decision making.
  • Collaborated with cross-functional teams to develop strategic plans aligned with organizational goals and objectives.
  • Championed diversity initiatives within the organization, fostering an inclusive environment that valued individual differences.
  • Provided guidance on ethical conduct, ensuring adherence to organizational values and principles.
  • Enhanced board effectiveness by conducting regular evaluations and providing ongoing training opportunities.
  • Evaluated organizational performance against key governance indicators, identifying areas requiring targeted interventions or improvements in policy application.
  • Assisted in the preparation of board materials, ensuring clarity and accuracy for informed decision making.
  • Supported board succession planning efforts, aiding in the identification and recruitment of suitable candidates.
  • Handled administrative requirements, maintained records and submitted operational reports.
  • Led team in developing strategic plans to meet operational objectives.
  • Monitored and assessed mission progress and provided updates to command.
  • Planned and coordinated tactical movements of personnel and equipment.
  • Prepared and delivered investigative reports and briefings.
  • Coordinated activities of subordinate personnel to support mission success.
  • Executed tactical operations with accuracy and control.
  • Created contingency plans to address unexpected tactical scenarios.
  • Developed and implemented plans to reduce risk to personnel and equipment during tactical operations.
  • Integrated intelligence activities into other military operations, plans and programs.
  • Communicated with command centers to develop and execute tactical plans.

Education

Master of Science - European Politics And Public Policy, MSc

Birkbeck College, University Of London
Birkbeck College, University Of London
04.2001 -

Bachelor of Science - Business And Economics

London Guildhall – London Metropolitan University
London Guildhall – London Metropolitan University
04.2001 -

Skills

    Auditing expertise

    Regulatory research

    Regulatory policies

    Regulatory submissions

    Global regulatory compliance

    Regulatory agency applications

    International regulations

    Document management

    Risk management

    Requests for information

    Product information

    Audits

    Inspections

    Clinical trials protocols

    Clinical development

    Regulatory strategy development

    Regulation compliance

    Cross-functional team leadership

    Teamwork

    Teamwork and collaboration

    Auditing skills

    Problem-solving

    Operational planning

    Time management

    Problem-solving abilities

    Leadership skills

    Multitasking

    Multitasking Abilities

    Excellent communication

    Decision-making

    Self motivation

    Time management abilities

    Adaptability and flexibility

    Critical thinking

    Effective communication

    Team collaboration

    Active listening

    Standard operating procedures

    Organizational skills

    Submission preparation

    Product documentation

    Clinical research

    Team building

    Attention to detail

    Problem-solving aptitude

    Adaptability

    Strategic planning

    Analytical thinking

    Relationship building

    Quality assurance

    Quality control

    Data management

    Project management

    Crisis management

    Analytical skills

    Data analysis

    Task prioritization

    Interpersonal skills

    Professionalism

    Stakeholder engagement

    Reliability

    Strategic partnerships

    Intellectual property law

    Written communication

    Training and development

    Continuous improvement

    Interpersonal communication

    Conflict resolution

    Process validation

    Policy implementation

    SOP development

    Audit management

    Process improvement

    Documentation management

    Staff training

    Goal setting

    Employee development

    Corporate communications

    Audit oversight

    Change management

    Resource allocation

    Policy development

    Regulatory filings

    Product development

    Budget administration

    Regulatory compliance

    Regulatory guidelines

Timeline

Research Governance Compliance Regulatory Manager

Barts Health NHS, Queen Mary University of London
01.2020 - Current

Master of Science - European Politics And Public Policy, MSc

Birkbeck College, University Of London
04.2001 -

Bachelor of Science - Business And Economics

London Guildhall – London Metropolitan University
04.2001 -

Senior Research Management and Governance Officer

Imperial College London
01.2000 - 01.2020

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Maria BrianaResearch Management, Governance, Compliance, Regulatory Submissions, Manager