Regulatory Project Manager Resume
Summary : As a Regulatory Project Manager, experienced in regulatory compliance and project management, led cross-functional teams, manage regulatory projects from inception to completion, and ensure compliance with regulatory requirements.
Skills : Knowledge of regulatory guidelines and standards, Project management and planning.
Description :
- Led regulatory compliance projects, including regulatory audits, assessments, and remediation efforts.
- Collaborated with stakeholders to define project scope, objectives, and deliverables.
- Developed project plans, timelines, and budgets, and monitored project progress to ensure on-time and within-budget delivery.
- Coordinated with internal teams, such as Compliance, Legal, Quality Assurance, and Operations, to implement regulatory requirements.
- Managed project documentation, including regulatory filings, approvals, and audit reports.
- Tracked record of successfully managing regulatory projects from inception to completion.
- Coordinated cross-functional teams, ensuring compliance with regulatory requirements, and driving project timelines and deliverables.
Experience
10+ Years
Level
Senior
Education
BBA
Regulatory Project Manager Resume
Summary : As a Regulatory Project Manager, provided guidance and support to team members, ensuring alignment with project goals and compliance objectives, ensuring that projects comply with relevant regulatory requirements, standards, and guidelines.
Skills : Communication, Interpersonal skills.
Description :
- Responsible for conducting regulatory research and analysis to interpret and implement regulatory requirements.
- Responsible for assisting in the development and enhancement of regulatory compliance programs and policies.
- Responsible for preparing and submitting regulatory filings, reports, and disclosures to regulatory agencies.
- Responsible for collaborating with cross-functional teams to address regulatory issues and implement corrective actions.
- Responsible for participating in regulatory audits and assessments, ensuring compliance with audit findings and recommendations.
- Responsible for preparing and maintaining document inventory for core dossier preparation.
- Responsible for prioritizing project-related tasks to efficiently complete essential tasks.
Experience
7-10 Years
Level
Management
Education
BBA
Regulatory Project Manager Resume
Headline : As a Regulatory Project Manager, responsible for directing documentation efforts to comply with domestic and international regulations and standards, responsible for playing a key role in acquiring necessary product licenses by developing comprehensive dossiers that met all required specifications set forth by authorities.
Skills : Strong analytical and problem-solving skills, Time management.
Description :
- Stayed updated with changes in regulations that may impact project activities and objectives.
- Developed comprehensive project plans, including scope, objectives, timelines, resources, and budget.
- Defined project deliverables and success criteria in alignment with regulatory goals.
- Collaborated with cross-functional teams, including Compliance, Legal, Quality Assurance, Operations, and Regulatory Affairs, to ensure alignment and coordination of project activities.
- Engaged with internal and external stakeholders, including regulatory agencies, to address project-related matters.
- Conducted risk assessments and developed risk mitigation strategies for regulatory projects.
- Identified potential risks, issues, and dependencies that may impact project timelines or outcomes.
Experience
5-7 Years
Level
Executive
Education
BBA
Regulatory Project Manager Resume
Objective : As a Regulatory Project Manager, implemented controls and measures to minimize risks and ensure project success, led project execution by overseeing project tasks, milestones, and deliverables.
Skills : Organizational skills, Risk assessment and mitigation.
Description :
- Monitored progress against project plans, identify variances, and take corrective actions as needed to keep projects on track.
- Communicated project status, updates, risks, and issues to project stakeholders, senior management, and regulatory authorities.
- Prepared and delivered project status reports, presentations, and recommendations as required.
- Maintained accurate and organized project documentation, including project plans, schedules, budgets, meeting minutes, and regulatory filings.
- Prepared and submited regulatory reports, disclosures, and documentation as per regulatory requirements.
- Ensured that project deliverables meet quality standards and regulatory expectations.
- Conducted quality reviews, audits, and assessments to verify compliance with regulatory requirements and project objectives.
Experience
2-5 Years
Level
Executive
Education
BBA
Regulatory Project Manager Resume
Summary : As a Regulatory Project Manager, managed changes to project scope, requirements, or timelines in accordance with change management processes, assessed the impact of changes on regulatory compliance and project outcomes, and communicate changes effectively to stakeholders.
Skills : Attention to detail, Ability to work under pressure and meet deadlines.
Description :
- Evaluated project performance, lessons learned, and best practices to drive continuous improvement in project management processes, regulatory compliance practices, and team effectiveness.
- Performed quantitative and qualitative analyses to correctly frame the issues and to offer feasible recommendations.
- Removed complexity from the implementation without compromising compliance.
- Minimized the collateral damage (unintended consequences) of regulations by identifying the most feasible options among various fully compliant possibilities.
- Ensured deliveries were made on time, within the budget allocated, and that the project was executed in line with the Regulator’s and internal requirements and timeline.
- Supported change management (training, procedures documentation) for the impacted teams.
- Ensured quality of both own and submission teamwork and compliance with regulatory guidelines and processes within the required timelines.
Experience
10+ Years
Level
Senior
Education
BBA
Regulatory Project Manager Resume
Summary : As a Regulatory Project Manager, experienced in an FDA regulated environment (preferably medical device), worked knowledge of the clinical laboratory and healthcare delivery system as it relates to government agencies and the enforcement of associated federal and state regulations.
Skills : Knowledge of industry-specific regulations, Proficiency in project management software.
Description :
- Designed, developed, and directed regulatory affairs initiatives and promote a culture of compliance and ethics.
- Worked independently and on projects with a team and filling various roles such as team member, facilitator, or leader.
- Efficiently used computer programs necessary to complete work requirements (MS Word, Excel, and PowerPoint).
- Experienced in project management roles within the technology or professional services industries.
- Tracked record in the delivery of major projects that include IT implementation.
- Ensured alignment and integration with the GPO initiatives and with the other Best in Class components.
- Assisted in the Development of the End state operating model and the supporting systems requests.
Experience
7-10 Years
Level
Management
Education
BBA
Regulatory Project Manager Resume
Headline : As a Regulatory Project Manager, created and managed project work plans, issues, risks, and key decisions, presented status of your work to senior management and stakeholders.
Skills : Ability to work collaboratively with cross-functional teams, Leadership.
Description :
- Monitored regulatory outcomes of initial product concepts and provide input to senior regulatory management.
- Assisted in the development of multicountry regulatory strategy and updated strategy based upon regulatory changes.
- Managed multiple work streams within complex regulatory projects.
- Internally worked in interface with RA officers in the RA centers and with the regional maintenance and compliance manager.
- Assisted the development of new businesses with existing and new clients for the provision of regulatory service.
- Worked closely with delivery partners in FRC IT and other areas of the bank.
- Drove the development and implementation of the IB business strategy.
Experience
5-7 Years
Level
Executive
Education
BBA
Regulatory Project Manager Resume
Summary : As a Regulatory Project Manager, coordinated objectives, scope, approach, and plans with other initiatives to ensure alignment, and manage stakeholders across the Rates and Credit Sales, Trading, and support functions globally.
Skills : Project management, Regulatory compliance.
Description :
- Led the implementation planning in conjunction with FRC IT.
- Managed the systems and processes of multiple change and remediation programs globally.
- Kept stakeholders informed of all aspects of implementation.
- Served as subject matter expert on regulatory change management topics
- Reported on status and monitor the day to day execution of the programme using both local and Head Office reporting tools including PRIME.
- Progressed reporting to the Head Office Steering Committee on a regular basis.
- Supported the development of processes within the Hambros PMO and champion the use and development of best practice tools and templates.
Experience
7-10 Years
Level
Management
Education
BBA
Regulatory Project Manager Resume
Summary : As a Regulatory Project Manager, developed comprehensive plans are used as a basis to manage the project and present progress to senior stakeholders. Responsible for successfully navigating complex international regulatory landscapes to expand product reach into new markets and territories.
Skills : Problem-solving, Team collaboration.
Description :
- Responsible for evaluating third-party vendors for regulatory services, selecting partners that best aligned with company objectives and values while maximizing return on investment.
- Responsible for devising robust contingency plans to address potential delays or challenges in the regulatory submission process, ensuring smooth project progression.
- Responsible for managing fees and applications, tracked product progress and handled all responses to regulatory inquiries.
- Responsible for optimizing resource allocation for regulatory projects by meticulously tracking timelines and deliverables, ensuring efficient use of personnel and budget.
- Responsible for achieving timely regulatory approvals by coordinating cross-functional teams and ensuring adherence to industry guidelines.
- Responsible for implementing standardized procedures for managing regulatory documents throughout their lifecycle, reducing inconsistencies and increasing overall organizational efficiency.
- Responsible for devising and deploying techniques for obtaining earliest possible approval for each product.
Experience
7-10 Years
Level
Management
Education
BBA
Regulatory Project Manager Resume
Headline : As a Regulatory Project Manager, responsible for working with internal team members to accomplish regulatory goals and achieve full compliance with all products, responsible for consulting with regulatory representatives to manage filings, applications, and reports.
Skills : Stakeholder engagement, Communication skills, Risk assessment.
Description :
- Responsible for improving communication between departments by establishing regular meetings and reporting systems, fostering collaboration on regulatory projects.
- Responsible for monitoring updates in regional regulations, disseminating crucial information within the organization to maintain current knowledge amongst colleagues.
- Responsible for conducting thorough gap analyses on existing regulatory documentation, identifying areas for improvement to ensure compliance with all relevant guidelines.
- Responsible for mentoring junior team members and providing support with their professional development, fostering a culture of continuous learning and improvement.
- Responsible for performing and documenting quality control checks to maintain compliance with company initiatives.
- Responsible for analyzing field studies and reports, compiled information and submitted concise and informative summaries.
- Responsible for providing responses to regulatory agencies regarding product information or issues.
Experience
5-7 Years
Level
Executive
Education
BBA
