Amanshe Perera Slaney
Nesconset,NY
Summary
Motivational leader and organizational problem-solver with advanced supervisory, team building and customer service skills. Experience stepping into roles and quickly making positive changes to drive company success. Focused on using training, monitoring and morale-building techniques to maximize employee engagement and performance.
Overview
12
12
years of professional experience
Work History
Sr. Director, Compliance & Regulatory Affairs
BioIVT
Westbury, NY
03.2022 - Current
- Developed and implemented strategic plans to maximize organizational efficiency, effectiveness, and profitability.
- Managed multiple projects simultaneously while ensuring deadlines were met.
- Provided guidance on best practices in project management to ensure successful outcomes.
- Created policies and procedures to improve operational efficiencies within the organization.
- Coordinated with stakeholders across multiple departments to develop innovative strategies for problem solving.
- Assessed current organizational systems and infrastructure, recommending changes as needed.
- Collaborated with executive leadership team to develop long-term objectives that would drive success.
- Monitored industry trends and made recommendations on how they could be leveraged by the organization.
- Lead cross-functional teams in developing creative solutions to challenging problems.
- Facilitated meetings between internal teams to ensure alignment on initiatives.
- Established key performance indicators to track progress towards goals.
- Promoted a culture of collaboration among staff members through regular communication, feedback, and recognition.
- Built relationships with external partners, vendors, and customers in order to foster collaboration.
- Evaluated training needs of employees based on job roles and responsibilities.
- Mentored junior staff members in their professional development journey.
- Recruited top talent from various sources in order to meet staffing requirements.
- Partnered with staff to create professional development plans to support personal and business growth.
- Formulated and deployed business transformation strategies to increase performance, profitability and business growth.
- Orchestrated strategic business plans and oversaw execution by streamlining customer support calls and enhancing customer experiences.
- Established compliance and regulatory strategic plans and operational objectives to strengthen policies and promote growth.
- Delivered hands-on assistance to committees and teams within department in policy-making decisions.
- Reduced outsourced vendor costs through supply chain visibility.
- Generated and implemented business procedures and policies.
- Oversaw operations of clinical development programs and clinical research.
- Conducted risk evaluations of facility operations, team performance and business policies to standardize activities.
- Revitalized quality and regulatory policies to strengthen operations.
Data Protection Officer
BioIVT
Westbury, NY
12.2021 - Current
- Developed and implemented data security policies and procedures to ensure compliance with applicable laws and regulations.
- Conducted risk assessments of existing systems, applications, and networks to identify potential vulnerabilities or areas for improvement in data protection.
- Provided guidance on data privacy issues such as best practices, standards, and controls.
- Monitored the implementation of data security measures across the organization.
- Assisted in developing training programs to educate staff on handling sensitive information securely.
- Ensured that all departments were adhering to company data protection policies and procedures.
- Evaluated third-party vendor contracts for potential risks related to data privacy.
- Created reports documenting findings from investigations into breaches of personal information or other violations of policy.
- Investigated incidents involving unauthorized access or misuse of donor/volunteer/subject and customer data.
- Responded promptly to inquiries from donors and customers regarding their rights under applicable law relating to their personal information.
- Collaborated with IT teams on projects related to improving the security posture of systems containing sensitive data.
- Maintained up-to-date knowledge of industry trends in privacy regulations, technology, and tools.
- Coordinated with external auditors during annual reviews of organizational processes and systems.
- Identified opportunities for process improvements that would enhance the effectiveness of the organization's data protection efforts.
- Established protocols for responding quickly and efficiently in the event of a breach.
- Drafted internal communications regarding changes in applicable laws or new initiatives designed to improve security posture.
- Provided advice on how best to handle requests from individuals seeking access or correction of their personal information held by the organization.
- Enforced policies governing the collection, use, storage, transfer, disposal and destruction of personally identifiable information.
- Made recommendations to improve security procedures and systems.
- Collaborated with stakeholders to implement and update disaster recovery plans.
Director, Compliance & Regulatory Affairs
BioIVT
Westbury, NY
01.2021 - 03.2022
- Directed the organization's daily operations, ensuring compliance with applicable laws and regulations.
- Developed policies and procedures to ensure compliance with corporate standards.
- Provided guidance on legal matters related to contracts.
- Assessed employee performance against established benchmarks or targets.
- Cultivated and maintained relationships to promote positive work culture.
- Guided and motivated staff to drive maximum performance.
- Analyzed problematic situations and occurrences to provide solutions and facilitate company survival and growth.
- Developed and presented new ideas and conceptualized new approaches and solutions.
- Supported work-life balance to improve staff morale.
- Met with stakeholders to address issues and implement solutions.
Associate Director, Regulatory Affairs
BioIVT
Westbury, NY
04.2019 - 01.2021
- Responsible for direct communications with regulatory agencies, including CBER and CDRH within FDA and UK's HTA.
- Oversee regulatory inspections and responses.
- Pioneer risk-based auditing and monitoring program for suppliers and clinical research sites.
Manager, Regulatory Affairs
BioIVT
Westbury, NY
08.2015 - 04.2019
- Established processes to ensure efficient workflow throughout the organization.
- Resolved conflicts between employees by providing guidance on company policies and procedures.
- Provided leadership during times of organizational change or crisis situations.
- Implemented new technologies to streamline operations, reduce costs, and improve customer service.
- Ensured compliance with all applicable laws, regulations, industry standards.
- Recruited and hired qualified candidates to fill open positions.
- Led team meetings and one-on-one coaching sessions to continuously improve performance.
- Enhanced team member performance through use of strategic and tactical approaches, motivational coaching and training.
- Created training modules and documentation to train staff.
Regulatory Specialist
BioIVT
Westbury, NY
10.2014 - 08.2015
- Reviewed and analyzed regulatory documents to ensure compliance with applicable laws and regulations.
- Conducted research on new regulations to keep up-to-date on changes in the industry.
- Prepared reports outlining potential risks associated with noncompliance of regulations.
- Provided training and guidance to personnel regarding regulatory requirements.
- Participated in internal audits to assess compliance with applicable laws and regulations.
- Developed processes for tracking, monitoring, and reporting compliance activities.
- Drafted policies and procedures for ensuring adherence to relevant legal standards.
- Identified areas where existing policies need improvement or updating due to changing legislation or regulation.
- Collaborated with legal counsel on matters relating to corporate governance and regulatory compliance.
- Provided advice on how best to manage risks associated with possible violations of applicable laws or regulations.
- Assessed potential impact of pending legislation or regulation on existing operations.
- Evaluated current practices against established standards set by regulatory bodies.
- Submitted applications and amendments to regulatory agencies.
- Managed regulatory change required by new and revised laws and regulations, communicating complex requirements and identifying operational impacts.
- Researched new regulatory requirements for CGT to gather information and launch resulting organizational changes.
- Observed and monitored contracts with outside suppliers to deliver regulatory support.
- Monitored regulatory change required by new and revised laws and regulations, communicating complex protocols and determining operational impacts.
- Enforced regulatory affairs department compliance with agency requirements.
- Guided negotiations with US and UK regulatory authorities to gain approval for bio specimen collections under research regulations.
Regulatory Coordinator
Central Florida Pulmonary Group
Orlando, FL
04.2013 - 06.2014
- Prepared documents for submission to relevant authorities as needed.
- Communicated regularly with external stakeholders regarding status updates on submissions.
- Managed 30+ actively recruiting, phase I-IV pulmonary associated clinical trials.
- Tracked progress of clinical trials and identified appropriate actions to achieve target objectives i.e., contract turnaround time, enrollment, timely IRB submissions, feasibility of studies, etc.
- Implemented effective and efficient processes using technology to manage day-to-day operations in support of research functions and team.
Registry Coordinator
Central Florida Pulmonary Group
Orlando, FL
03.2012 - 06.2014
- Improve accuracy of data of cystic fibrosis patient registry (Port CF) by recording validated data points through chart review.
- Increase number of operators and train operators to use registry effectively.
- Increase number of patients in registry and thereby increase research recruitment of eligible patients and grant funding.
- Co-lead quality improvement initiative with Dartmouth University and Cystic Fibrosis Foundation.
- Compiled detailed spreadsheets with patient demographic information for use in research studies.
- Reviewed incoming documents for accuracy and completeness before entering into the registry database.
- Investigated potential errors or inconsistencies in patient data prior to submission.
- Collaborated closely with other departments to ensure timely resolution of any issues related to the registry system.
- Managed communications between stakeholders regarding updates or modifications made within the registry database.
- Accessed patient charts to collect, abstract and extrapolate patient data.
Education
Graduate Certificate in Regulatory Affairs - Clinical & Industrial Drug Development
The George Washington University
Washington, DC08.2024
Graduate Certificate in Human Resources Management -
Keller Graduate School of Mgmt At DeVry University
Orlando, FL05.2014
Master of Public Administration - Health Care Management
Keller Graduate School of Mgmt At DeVry University
Orlando, FL03.2014
BBA - Health Services Management
DeVry University
Orlando, FL03.2013
Some College (No Degree) - Pre-Medicine
Columbia University in The City of New York
New York, NYSome College (No Degree) - Leadership & Human Resources Management
Disney Institute
Orlando, FLSome College (No Degree) - Business Administration
Nassau Community College
Garden City, NYSkills
- Key Performance Indicators
- Core Values Management
- Team Building and Motivation
- Policy Development
- Leadership
- Communication
- Negotiation
- Analytical
- Problem-Solving
- Presentation
- Legal Knowledge
- Interpersonal and Collaboration
- Regulatory Submissions
- GxP
- Auditing and Monitoring
- Risk Analysis and Mitigation
Languages
English
Native/ Bilingual
Sinhala
Native/ Bilingual
Tamil
Limited
References
References available upon request.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
A mature person is one who does not think only in absolutes, who is able to be objective even when deeply stirred emotionally, who has learned that there is both good and bad in all people and all things, and who walks humbly and deals charitably with the circumstances of life.
Eleanor Roosevelt
Timeline
Sr. Director, Compliance & Regulatory Affairs
BioIVT
03.2022 - Current
Data Protection Officer
BioIVT
12.2021 - Current
Director, Compliance & Regulatory Affairs
BioIVT
01.2021 - 03.2022
Associate Director, Regulatory Affairs
BioIVT
04.2019 - 01.2021
Manager, Regulatory Affairs
BioIVT
08.2015 - 04.2019
Regulatory Specialist
BioIVT
10.2014 - 08.2015
Regulatory Coordinator
Central Florida Pulmonary Group
04.2013 - 06.2014
Registry Coordinator
Central Florida Pulmonary Group
03.2012 - 06.2014
Graduate Certificate in Regulatory Affairs - Clinical & Industrial Drug Development
The George Washington University
Graduate Certificate in Human Resources Management -
Keller Graduate School of Mgmt At DeVry University
Master of Public Administration - Health Care Management
Keller Graduate School of Mgmt At DeVry University
BBA - Health Services Management
DeVry University
Some College (No Degree) - Pre-Medicine
Columbia University in The City of New York
Some College (No Degree) - Leadership & Human Resources Management
Disney Institute
Some College (No Degree) - Business Administration
Nassau Community College
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