Regulatory Project Manager Resume Sample
Aniyah Armstrong
7336 Kerluke Fort,
Boston,
MA
+1 (555) 435 8184
Work Experience
Regulatory Project Manager
07/2015
-
PRESENT
Los Angeles, CA
- Within the overall programme structure, set up, design, mobilise and then manage the day-to-day activities of the workstream, including development of the plan, with Business and IT, resourcing, status reporting, cost management, RAIDS management, plan management, etc
- Perform quantitative and qualitative analyses in order to correctly frame the issues and to offer feasible recommendations
- Remove complexity from the implementation without compromising compliance
- Minimize the collateral damage (i.e. unintended consequences) of regulations by identifying the most feasible options among various fully compliant possibilities
- Ensure deliveries are made on time, within the budget allocated and that project is executed in line with Regulator’s and internal requirements and timeline
- Support change management (training , procedures documentation) for the impacted teams
- Ensures quality of both own and submission team work and compliance with regulatory guidelines and process within the required timelines
- Experience in an FDA regulated environment (preferably medical device)
- Working knowledge of the clinical laboratory and healthcare delivery system as it relates to government agencies and the enforcement of associated federal and state regulations
Senior Regulatory Project Manager
01/2012
-
06/2015
Chicago, IL
- Set priorities and adapt to changing business needs and manage multiple projects within established time frames
- Clearly and effectively communicate complex issues and concepts orally and in writing
- Effectively and confidentially advise and interact with Myriad executives, department directors and managers, Legal Department, staff, and external organizations and agencies
- Design, develop, and direct regulatory affairs initiatives and promote a culture of compliance and ethics
- Work independently and on projects with a team and filling various roles such as team member, facilitator, or leader
- Efficiently use computer programs necessary to complete work requirements (MS Word, Excel, and PowerPoint)
- Experience in project management roles within the technology or professional services industries
Client Data Services Regulatory Project Manager
07/2005
-
10/2011
Detroit, MI
- Knowledge and experience of working within the regulatory environment
- Knowledge of the custody industry and / or related financial services experience
- Good IT skills including MS Project
- Good negotiation, decision making, problem solving and influencing skills
- In the finance services industry or similar
- Proven track record in the delivery of major projects that include IT implementation
- Ensure alignment and integration with the GPO initiatives and with the other Best in Class components
- Assist in the Development of the End state operating model and the supporting systems requests
Education
University of New Mexico - Taos Campus
2000 - 2004
Bachelor's Degree in Science
Professional Skills
- Proven experience of working effectively with commercial parts of the organisation and adding value
- Regulatory Experience: 2-3 years regulatory reporting working experience (optimal), preferably in the financial industry
- Demonstrated experience leading and working in cross-functional teams
- Demonstrates an understanding of company priorities and responds appropriately and flexibly to ensure deadlines are met successfully
- Recent experience of working with products in the earlier phases of development but broad experience with marketed and pre-marketed products overall
- Relevant regulatory experience or experience elsewhere in Pharmaceutical Industry e.g. CRO, Marketing Company, Health Authority, R&D or Operations
- Prior Banking experience (No later than 2013)
How to write Regulatory Project Manager Resume
Regulatory Project Manager role is responsible for interpersonal, training, organization, manufacturing, credit, integration, security, reporting, design, consulting.
To write great resume for regulatory project manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Project Manager Resume
The section contact information is important in your regulatory project manager resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Regulatory Project Manager Resume
The section work experience is an essential part of your regulatory project manager resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous regulatory project manager responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory project manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Project Manager resume experience can include:
- Excellent team working abilities and effective influencing skills in a matrix team environment
- Excellent written and verbal communication, negotiation and influencing skills
- Three or more years of regulatory affairs experience or experience working closely with regulatory affairs in a related discipline
- Experience with data-related projects (modeling, optimizing, and sourcing)
- Experience in CMC regulatory affairs with authoring or preparing CMC content for clinical trial applications and/or marketing applications
- Six years’ experience in project management or leading teams and/or strategic planning, and/or regulatory policy
Education on a Regulatory Project Manager Resume
Make sure to make education a priority on your regulatory project manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory project manager experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Regulatory Project Manager Resume
When listing skills on your regulatory project manager resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical regulatory project manager skills:
- Highly-developed interpersonal skills, and strong attention to detail
- Effectively builds positive relationships within Labeling team and with other GSK colleagues
- Project management skills developed in a project manager and/or business analyst role (5+ years)
- Financial skills to manage project's operating and capital budgets
- Experience in clinical research, quality systems, or regulatory experience in medical device or pharmaceuticals industry
- Monitoring of operational risks and review of effectiveness of prevention measures
List of Typical Experience For a Regulatory Project Manager Resume
1
Experience For Senior Regulatory Project Manager Resume
- Experience in clinical research, quality systems, or regulatory experience in medical device or pharmaceuticals industry
- Negotiate priorities and defend point-of-views with peer leads of other GPO Best in Class work streams
- Project management experience within financial services or asset management industries
- Strong interest in federal health policy that is put into action to guide Michigan Medicine decisions
- Strong command of medical and surgical terminology
- Project management and/or management of people experience
- Performing regulatory review of clinical trial related documents
2
Experience For CMC Regulatory Project Manager Resume
- Develop and deliver (in coordination with existing training resources) regulatory training and awareness programs
- Manage CER Specialists’ efforts in writing and editing of scientific content of deliverables, and the timelines of these documents
- Function as the problem resolution liaison, assisting Myriad employees with questions and issues regarding regulatory submissions
- Supports Myriad Training Specialist with employee training for FDA required trainings
- Contribute to Project Team target setting and performance reviews
- Contributes to regular reporting at portfolio level and other key stakeholders as and where required
- Involvement in the monitoring of associated elements to the budget
- Display, or actively gather, a detailed understanding for the business needs and objectives of MFS and related internal clients globally based on project
3
Experience For Client Data Services Regulatory Project Manager Resume
- Design the program details necessary for a successful transportation electrification filing, and
- Provide strategic guidance on regulatory requirements to new product development teams and sustaining teams
- Continually improve knowledge of current and pending revisions to regulatory compliance guidelines and safety requirements
- Proposal to adjust financial plan, when better insight reveals more appropriate costs
- Manage project team members consistent with our management principles
4
Experience For Regional Regulatory Project Manager Resume
- Ensure projects are compliance to the Programme Governance Framework
- Representing Human Resources in company-wide committees and working groups tasked with key initiatives required by the Firm’s regulatory agencies across the globe
- Proactive RAID management - carefully identifies and mitigates risks, escalates high severity issues, monitors interdependencies between the business and ITEC plan and maintains an awareness of constraints
- Ensures that project documents are complete, current and appropriately communicated to stakeholders (e.g. PDD, Steering Committee packs)
- Ring-fences and protects the delivery of the project, ensuring that there is a clear view of scope at the start of the project, which is monitored and reviewed throughout the project lifecycle – escalating scope creep or out of scope items to the project sponsor
5
Experience For Human Resources Bank Regulatory Project Manager Resume
- Improvement of the operational efficiency (costs, efficiency of it development, etc)
- Ensure compliance with policies, procedures within the business line
- Further the business goals of MFS through the direct management and execution o f best-in-class projects/solutions for MFS
- Build strong relationships with business divisions and departments across MFS globally; represent, champion and further the goals and opportunities of MFS teams in support of assigned initiatives
- Plan, implement and control project work
- Manage and monitor all project deliverables to successful completion, leverage EPMO best practices and complete project artifacts as appropriate
6
Experience For Risk Regulatory Project Manager Resume
- Actively create and manage project work plans, issues, risks, and key decisions
- Actively communicate with project team members, sponsors, and stakeholders; Create and present status reports and presentations to senior management
- Create metrics to measure project success
- Conduct lessons learned meetings/surveys and analyze data and report to sponsor and team
- Strong interpersonal and management skills, including the ability to work across the organization and interact/influence/negotiate effectively at all levels of management and peers
- Excellent interpersonal, communication, and management skills. Experience designing and delivering presentations and training to diverse audiences, including senior management, administrative staff members, technical and non-technical personnel, and clients of MFS
- Interact with all levels of MFS management
7
Experience For Program Analyst / Regulatory Project Manager Resume
- Exceptional verbal and written communication essential
- Directly responsible to the Manager of Quality Analytics
- Conducts analysis of proposed and enacted federal regulations, legislation and programs from the perspective of impact on Michigan Medicine
- Monitors external communications for impactful announcements that can influence program interpretations and readiness efforts
- Building upon a strong foundational knowledge of the Firm’s businesses and organization and the regulatory environment, become an internal expert regarding change programs driven by the Firm’s obligations to its regulators. In this context, understand the responsibilities of Human Resources with respect to the execution of such programs
8
Experience For Regulatory Project Manager Interdisciplinary Resume
- Leads the development of content (e.g., testimony, analysis, and other relevant material) for TE-related regulatory filings
- The Senior Project Manager is the lead subject matter expert for SCE’s next application for transportation electrification programs, including proposed investments and rate designs, which is likely to be focused on light-duty vehicle adoption
- Work closely with Strategy, Integrated Planning and Performance (SIPP), Customer Service (BCD and CP&S), Law and Transmission & Distribution organizations to do the following
- Develop programs aimed at accomplishing the objectives,
- Identify SCE’s primary strategic policy objectives,
9
Experience For Regulatory Project Manager for Automatic Exchange of Information Resume
- Provide subject matter expertise for the application at the CPUC in order to ensure that programs are successfully approved
- Work with business partners across R&D, Marketing and Supply to identify key requirements for projects to ensure right first time dossier creation and submission
- Work with external consultants and contract research organisations to ensure timely, high quality submissions
- Responsible for delivery of regulatory dossier to agreed time frames
- With Regulatory bodies and business partners, ensure timely responses to questions and ensure all external process deadlines are met
- Collaborate with Local Regulatory colleagues to ensure national registrations are achieved and maintained
- Collaborate across business functions to ensure timely delivery and robust and consistent project updates
- Support internal compliance activities and initiatives to ensure regulatory compliance
- Ensure Regulatory and Audit agendas are on track/resourced
10
Experience For Ihc-regulatory Project Manager Resume
- Track financials related to software and hardware expenditures, resource allocation
- Develops persuasive comments, arguments, and filings submitted to regulatory agencies to advocate SCE’s position
- Represents SCE in proceedings with various regulatory agencies, other utilities, regional & national industry organizations, interveners, customers, and other departments and/or parties
- Leads cross-functional teams to identify and address strategic issues associated with regulatory proceedings
- Coordinates the development of company’s positions, processes, and strategies with internal stakeholders. Interacts with internal and external parties to advance SCE’s positions
- Maintains thorough knowledge of regulations, rules, and procedures. Coordinates with Subject Matter Experts (SME) to develop recommended positions and propose changes to draft regulations and legislation
List of Typical Skills For a Regulatory Project Manager Resume
1
Skills For Senior Regulatory Project Manager Resume
- Nonclinical Judgment Experience – Has demonstrated a proven track record of effectively applying expertise to make good strategic regulatory decisions
- Excellent documentation and communication skills. Has the interpersonal relationship skills and the attention to the detail to drive achievement of objectives
- Self-motivation coupled with strong analytical skills, and process control skills mindset
- Demonstrated good organization and time management skills and ability to manage tight timelines when required
- Strong organizational, interpersonal and written/verbal communication skills required
- Quick learner, with ability to swiftly understand complex details/data and effectively communicate complicated analysis and results to business partners
2
Skills For CMC Regulatory Project Manager Resume
- In depth understanding and practical experience of national or/and EU regulations, guidelines and working practices
- Financial institution experience, preferably with exposure to consumer banking, commercial banking and enterprise risk systems
- Competent and experienced in interacting with staff outside direct reporting line
- Experience with regulatory reporting (at least 3 years)
- Regulatory experience with development of Medical Device and Biologic products required, including PMA, BLA and/or 510(k)
- Experience with technical aspects of product development and manufacturing
- A proven track record of successfully delivering projects within an global financial services environment
- "Experience managing agile projects" is requested but not required
3
Skills For Client Data Services Regulatory Project Manager Resume
- Prior knowledge of "navigating" within the bank to multiple business and tech groups
- IT audit experience, IT Risk in a large complex organizational setting
- Strong understanding of the COBIT Control Framework,
- Recent experience of working directly with the EMA / other external agencies
- Experience in project lifecycle management, feasibility analysis and conceptual design through development, implementation, training and rollout
- Agile experience being a scrum master
4
Skills For Regional Regulatory Project Manager Resume
- Excellent analytical ability to understand the complexity of the business and identify related business issues
- PM experience within technology organization
- Proficiency in various computer applications and the ability to quickly gain knowledge of, and operate in, internal databases
- Demand Management: Strong capacity for operating in a flexible, dynamic, and high pressure environment where creative thinking is required
- Responsible for ensuring compliance with the current PCMS regulatory procedures and updating the procedures when new regulatory requirements become effective
- Relationship Management: Ability to build strong working relationships with business partners across the firm and with other functions
5
Skills For Human Resources Bank Regulatory Project Manager Resume
- Previous experience working on FATCA and/or regulatory projects
- Experience with regulatory reporting, such as Y9C, FR Y-14M, FR Y-14Q, or FR Y-14A
- Demonstrated learning agility of new subject matter
- Experience working as a project manager in an enterprise environment
- Analyze business issues, working with sponsor to create effective enterprise solutions
- Provide project management, prioritization, direction, and leadership to team members in order to accomplish defined project deliverables
6
Skills For Risk Regulatory Project Manager Resume
- Work with project team to allocate resources appropriately. Review demand and capacity and can work out conflicts or reprioritize as needed
- Demonstrated ability to work independently on a wide array of corporate projects
- Serve as a subject matter expert in the field of Project Management, maintaining a solid understanding of the field and its related technologies
- Practical experience leading projects through all phases of delivery
- Established work experience in relevant fields
- Improving Conduct Risk framework and ensuring that actions deriving from conduct risk management information are taken forward
- Working knowledge of Quality Systems, ISO 13485, and 21CFR 820
7
Skills For Program Analyst / Regulatory Project Manager Resume
- Understanding HR’s role in the context of Firm-wide risk and strategic initiatives, and collaborating with counterparts in other business units
- Is considered authoritative source for FDA and GSK requirements for prescribing information, including XML labeling
- Able to make judgements and take one off actions to meet specific project need or solving immediate problem while balancing competing calls on time
- Knowledge of new and developing regulatory and pharmacovigilance expectations
- Data Management knowledge, i.e. Basel, regulatory stress testing
- Advise on the definition and monitoring of permanent supervision and other controls around projects
8
Skills For Regulatory Project Manager Interdisciplinary Resume
- Support license maintenance, change control requests, and post-approval submissions while ensuring delivery to agreed timelines
- Managing large projects Licenses/Certifications Certified Information Systems Auditor (“CISA”),
- Thorough understanding of pharmacology, toxicology and pharmacokinetics related to drug development
- Thorough understanding of regulatory processes and issues
- Thorough understanding of the regulations relevant to nonclinical development
- Monitor project budget and resources working with EPMO colleagues and project team members, escalate issues as appropriate
- Align functional expertise and solutions to meet the changing demands of clients, competitors and regulators
9
Skills For Regulatory Project Manager for Automatic Exchange of Information Resume
- Develops expertise in assigned subject areas and provides recommendations to leadership regarding formal policy interpretations and implementation requirements
- An enquiring mind and the tenacity to find the solution to difficult problems
- Drive planning at various organizational levels
- Leads regulatory case management functions. Prepares or help prepare testimony or position statements, ensuring the company's position is reflected accurately
- Reviews and advices junior staff in regards to the maintenance of various regulatory records and databases with information related to study
10
Skills For Ihc-regulatory Project Manager Resume
- Documentation to support Military Spouse Preference needs to be submitted at time of application
- Demonstrates an understanding of regulatory labeling requirements for US prescribing information submissions, and a detailed understanding of internal policies, procedures, and guidelines. Uses this knowledge to initiate or provide input into the authoring of prescribing information, and to produce all required labeling documents for US submissions
- Work with project teams to resolve issues regarding prescribing information requirements
- Identify issues and independently devise and implement solutions
- Projects are assigned on the basis of relative priority, available of resource and complexity i.e. in terms of size, nonclinical issues and variety of outputs required
List of Typical Responsibilities For a Regulatory Project Manager Resume
1
Responsibilities For Senior Regulatory Project Manager Resume
- Strong oral and written communication experience and skills
- Five or more years of strong project management experience or consulting skills
- Strong skills in the use of Microsoft Office applications (particularly Excel, Access and Powerpoint)
- Strong interpersonal, managerial and organisational skills
- Prior experience of leading global change projects to a successful conclusion
2
Responsibilities For CMC Regulatory Project Manager Resume
- Experience as a leader to set priorities, achieve desired actions and outcomes through negotiation and influence
- Experience in setting priorities and to achieve desired actions and outcomes through negotiation and influence
- Proven track record as a project manager and/or experience in a relevant regulatory field
- Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
- Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 3 and 4
3
Responsibilities For Client Data Services Regulatory Project Manager Resume
- Direct, or be responsible for, the CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities
- CMC (Module 3) authoring experience
- Strong technical understanding of drug substance and/or drug product elements of Module 3
- Knowledge of and experience in applying CMC regulatory requirements in global markets
- Experience of evaluation and provision of CMC regulatory advice to in-licensing and divestment projects
4
Responsibilities For Regional Regulatory Project Manager Resume
- Four years of experience in project management or similar cross-functional coordination within a regulated environment or industry
- Five or more years of project management or case management experience in the energy industry
- Demonstrated ability to train junior staff and the ability to motivate and lead others
- Post graduate scientific and regulatory experience
- At least six years of relevant experience in project and programme roles
5
Responsibilities For Human Resources Bank Regulatory Project Manager Resume
- Previous experience or exposure to regulatory matters
- Cross-functional team management experience in a matrix organization
- Preparing and distributing labelling documents within stipulated timelines
- Preparing for and running local procedures following the EMEA Regulatory Affairs
- Working knowledge of ICH Quality by Design principles with direct application to pharmaceutical product development and life cycle management
- Partnering with allocated commercial teams to provide regulatory expertise and support
- Collecting regulatory competitive intelligence as required
- Maintain high quality standards and behaviours including being customer driven, using flexible thinking and employing continuous improvement approaches
6
Responsibilities For Risk Regulatory Project Manager Resume
- Prepares and distributes local labelling documents within stipulated timelines following
- Ensure that projects follow group policies (including reporting and governance)
- Supports business unit by providing leadership and guidance on global regulatory strategy, such as CE Marking, product registrations, and clinical evaluations
- Manage the review cycles and any follow up round tables as needed per the filing timelines
- Help identify and support strategic opportunities to improve reporting requirements
- Manage annual tabletop testing events, and crisis communication playbooks, in partnership with resiliency
- Pull together monthly forecasting/inputs for Resolution & Recovery analyses (e.g. Material Legal Entity Assessments)
7
Responsibilities For Program Analyst / Regulatory Project Manager Resume
- Knowledge of XML labeling
- Negotiate solutions to complex labeling issues
- Knowledge of drug development and/or manufacturing and supply processes
- Successful track record of managing multiple projects/teams simultaneously
- Participation in/leading business critical activities within and external to the organisation
- Continued professional growth in global regulatory affairs leading to sound knowledge of worldwide CMC regulatory requirements for biopharmaceutical products
- Broad banking expertise and/or in-depth expertise in areas, which are significantly impacted by regulatory changes
- Drive progress under uncertainty and frequently changing requirements
8
Responsibilities For Regulatory Project Manager Interdisciplinary Resume
- Ambition to rather quickly gain a thorough understanding of the AEI regulations and relevant KYC processes
- Develop solutions that address regulatory requirements (including the design of business processes and policies) in a client-friendly manner
- Responsible for the content of the local labelling documents released to prescribers and
- Prepares for and manages local procedures following the EMEA Regulatory Affairs
- Strategic plan, assuring timely execution and compliance
- Take ownership of projects, managing deliverables (scope, budget, timeline)
- Provide reporting to stakeholders on project statuses
- Rapidly build product knowledge and understanding of highly technical and scientific regulatory activities
9
Responsibilities For Regulatory Project Manager for Automatic Exchange of Information Resume
- Results oriented with focus on achieving overall business objective
- Monitors progress, communicates status, and elevates issues as necessary
- Manages cross-functional teams to complete discovery, respond to data requests, and meet deadlines for regulatory filings
- Help coordinate witness preparation process for hearings
- Reports on regulatory activities to Regulatory Affairs management team. Supports the regulatory activities of the organizational unit(s) assigned
- Leads regulatory case management functions. Prepares or help prepare testimony or position statements, ensuring the company's position is reflected accurately. Develops comments, arguments, and filings submitted to regulatory agencies to advocate SCE’s position
- Develops persuasive comments and testimony for various filings and submittals to CPUC, and as needed, to other regulatory agencies such as the FERC, CEC or CAISO
- Leads cross-functional teams to address strategic issues associated with regulatory proceedings
10
Responsibilities For Ihc-regulatory Project Manager Resume
- Identifies and manages resolution of complex regulatory issues
- Coordinates the development of company’s positions, processes, and strategies. Interacts with internal and external parties to advance SCE’s positions
- Coordinates with Subject Matter Experts (SME) to develop recommended positions and propose changes to draft regulations and legislation
- Manages cross-functional teams to complete discovery, respond to data requests, and meet deadlines for regulatory filings. Identifies tasks required to complete regulatory requirements
- Interprets regulatory requirements and provides technical support, oversight and guidance to the business to ensure compliance
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