Regulatory Compliance Specialist Resume Sample
Kieran Bruen
3314 Quitzon Centers,
Chicago,
IL
+1 (555) 989 3158
Work Experience
Regulatory Compliance Specialist
03/2018
-
PRESENT
Detroit, MI
- Education Required: MBA, MSc in law or related discipline
- Experience in securities market regulations
- A genuine interest in the financial markets
- Ensures compliance with all safety laws, standards, regulations, and policy (OSHA, Workman’s Compensation, etc.)
- Support Company Initiatives, especially the Company’s 123SQP plan
- Knowledge of GMP guidelines ICH Q7 and 21CFR210/211/Part 11 as well as international regulations pertaining to the production of APIs and testing of drug products
- Knowledge and understanding of the oligonucleotide manufacturing or related pharmaceutical manufacturing processes
- Experience in performing internal and external audits in a GMP pharmaceutical environment
- Read, analyze, and interpret industry related periodicals, SOPs, and government regulations. Ability to write reports, business correspondence, and procedures. Ability to respond to common inquiries or complaints from customers, co-workers, subordinates, and supervisors regarding the products and processes
Senior Regulatory Compliance Specialist
06/2013
-
10/2017
Phoenix, AZ
- Prior compliance/regulatory experience and/or training working in a GMP pharmaceutical production environment is required
- Occasional travel between Boulder, CO and Frederick, CO site is required
- Provide technical support to Specialists and Coordinators related to project evaluation methods and environmental compliance customer service practices
- Advise on change order proposals that exceed specific scope and cost thresholds
- Oversee preparation of permit applications and cooperative agreements
- Monitor bird site management process quality
- Monitor processing of new build projects, redevelopment projects, and tower acquisition deals to optimize work flow and compliance review closure timeline
- Monitor consultant adherence to scopes of work, including deliverable schedules
Senior Water Quality Regulatory Compliance Specialist
09/2007
-
01/2013
Philadelphia, PA
- Lead monthly team meetings focused on project review trends, environmental services trends, cross-functional training needs, and customer service best practices
- Work closely with the Director, Regulatory Compliance to develop new training material and deliver training to core team and project teams
- Facilitate relationships with cross-functional groups to foster support for environmental practices that ensure processes, toolsets, and timelines are working and streamlined where possible
- Acts as a leader within the CPS Marketing and Product groups to promote a culture of compliance that supports business objectives
- Work with Marketing leadership and other business partners to provide training and communications to the business on all applicable regulatory and policy requirements, including Branding updates; fosters cooperation and involvement between the Marketing Shared Services, Compliance and Product groups
- Manages all aspects of the compliance review processes for marketing and other client facing deliverables
- Promotes process innovation to decrease risk and support standardization across the business
- Liaises between the business line and corporate compliance and communications groups on business-critical projects and efforts
Education
Huntington University
2001 - 2006
Bachelor's Degree in Chemistry
Professional Skills
- Knowledge of waste stream analysis, recycling and regulatory compliance relative to large format Li-ion batteries, chemicals and airbags. (Hazardous waste regulations)
- Excellent organizational skills and ability to prioritize, manage and track multiple ongoing projects/products
- Demonstrate strong people skills and maintain effective interpersonal relationships
- Excellent interpersonal, oral, and written communication skills. Ability to communicate effectively with internal and external vendors and customers
- Excellent interpersonal skills - enjoys working and interacting with people
- Excellent computer and typing skills including knowledge of Microsoft Word, Excel, PowerPoint, Access, Outlook and the Internet
- Strong interpersonal skills and the ability to communicate well -- verbal and written
How to write Regulatory Compliance Specialist Resume
Regulatory Compliance Specialist role is responsible for organizational, computer, microsoft, analytical, planning, organization, interpersonal, government, database, administrative.
To write great resume for regulatory compliance specialist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Compliance Specialist Resume
The section contact information is important in your regulatory compliance specialist 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 Compliance Specialist Resume
The section work experience is an essential part of your regulatory compliance specialist 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 compliance specialist 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 compliance specialist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Compliance Specialist resume experience can include:
- Demonstrated excellent project management skills
- Demonstrated ability to effectively communicate with a variety of managerial levels
- Position requires excellent written & verbal communication skills
- Excellent writing and report preparation skills
- Strong skills with Microsoft business products, e.g. Excel, PowerPoint, Word, etc
- Strong computer skills with Microsoft Office Suite tools and applications (Word, Excel, PowerPoint, Outlook); browsers such as Internet Explorer and Firefox
Education on a Regulatory Compliance Specialist Resume
Make sure to make education a priority on your regulatory compliance specialist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory compliance specialist 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 Compliance Specialist Resume
When listing skills on your regulatory compliance specialist 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 compliance specialist skills:
- Think creatively and innovatively to resolve issues not covered by existing policies.Strong proofreading and editing skills
- Strong customer service, decision-making, interpersonal, leadership, organizational planning and problem solving skills
- Strong time management, planning and organizational skills required
- Good presentation, written and oral communication skills
- Excellent organizational, problem-solving, and analytical and time management skills
- Excellent interpersonal, written English and oral communication skills
List of Typical Experience For a Regulatory Compliance Specialist Resume
1
Experience For Senior Regulatory Compliance Specialist Resume
- Excellent teamwork and communication skills and the ability to manage multiple projects simultaneously with minimal supervision
- Communicate effectively with key stakeholders to include, but not limited to Campari management, employees, external law offices and regulatory agencies
- Resolve issues timely and effectively
- Reviewing design, functional and testing documentation to ensure compliance to cGMP and Good Documentation Practices
- Facilitating the development and maintenance of effective assessment protocols
- Working experience, preferably from the banking, accounting, or financial institution
- Working experience, preferably from the banking sector or otherwise related to securities trading or administration
2
Experience For Field Regulatory & Compliance Specialist Resume
- Experience facilitating or leading projects
- Professional experience with various federal and state regulatory online filing systems
- Knowledge and experience with ISO and FDA regulations
- Demonstrated ability to pay meticulous attention to detail
- Five (5) years of regulatory compliance experience in a chemical or food related industry
3
Experience For Senior Water Quality Regulatory Compliance Specialist Resume
- Participate in the development and maintenance of effective assessment protocols and test programs
- Experience with ISO Accreditation audits and procedures
- At least four years of relevant experience working for or with companies in heavily regulated industries, preferably within the beverage alcohol world
- Prepare, conduct and assess effectiveness of GMP Training
- Other desirable experience includes specialized fields such as radiation safety, laser safety, robotics safety, construction safety, etc
4
Experience For Offshore Regulatory Compliance Specialist Resume
- Advanced knowledge and use of business application software and technology experience
- Communicate regulatory requirements through effective written and verbal channels
- Maintain records of approvals and related communications to demonstrate regulatory compliance
- Working as part of a team dealing with global registrations and providing regulatory guidance, direction and support to all External Manufacturing groups
- Developing, monitoring, and reporting on the results of assessments
- Developing, monitoring, and reporting on the results of internal reviews and assurance assessments
- Identifying process improvements and best practices observed in the field or recommended by others and ensuring implementation by working with key stakeholders
- Gathering data and creating reports to ensure relevant data is on hand when making critical decisions
5
Experience For Senior Field Regulatory & Compliance Specialist Resume
- Monitoring all state insurance laws, regulations and bulletins and forming any needed action plans to ensure company’s legal compliance
- Identifying organizational risks and trends; making local and Williams’s recommendations commensurate with the level of risk or applicability
- Leading and managing Management System assessments for the organization
- Leading and managing Tier 1, 2, and 3 Management System assessments and targeted reviews for the organization
- Presenting organizational learnings and recommendations to the senior and the Operating Area Leadership Teams
- Leading the development of appropriate criteria and the execution of reviews, audits and field observations as well as coordinating closure of findings
- Identifying training requirements
- Providing training as required
- Reviewing and approving changes to project design documents relevant to cGMP aspects
6
Experience For Nutrition & Labeling Regulatory Compliance Specialist Resume
- Acting as the internal Subject Matter Expert (SME) on the Management System requirements
- Participating in non-routine internal assessments in response to management concerns for internally or externally discovered non-compliance issues
- Working knowledge of CPSC and FTC regulations and interpretation consistent with consumer products
- Coordinating company-wide compliance programs
- Coordinating the implementation of regulatory initiatives related to standards, processes or procedures
- Supporting the CQV Team
- Monitoring of compliance with chart audits, tools such as tracers, rounds, mock surveys
- Supporting the Regulatory Compliance Manager in executing regulatory compliance project activities (defined here below) and providing progress monitoring
7
Experience For Quality & Regulatory Compliance Specialist Resume
- Focusing the cGMP regulations that are relevant to the project and advising the Engineering Team
- Participating in other QA supporting activities as required (e.g. internal audits, site regulatory inspections, APQR’s, quality risk management)
- Issuing the project cGMP Design Brief and Reports
- Keeps abreast of changes in regulations, including attending trade conferences and seminars – including trade association representation
- Communicates with Accrediting/Regulatory agencies regarding survey planning, preparation, and responses
- Maintain training and awareness of related US federal regulations pertaining to Medical Device Reporting and recall activities
- Maintains technical documentation, including product DMRs, relating to CooperVision’s products
8
Experience For Environmental & Regulatory Compliance Specialist Resume
- Evaluation, problem-solving, and decision-making abilities
- Directly responsible for managing the following activities in Regulatory Compliance
- Has a working knowledge of International Food Additive and Food Labeling regulations to support regulatory review & compliance process as needed
- Ensures compliance and auditing of Driver Management Program including DOT and Non-DOT Driver Qualifications
- Conduct internal audit of DOT training courses to ensure driver training meets DOT requirements
- Maintain detailed testing history including physical and electronic files/database as required, test results, certificates of compliance, etc
9
Experience For Regulatory / Compliance Specialist, Senior Resume
- Track and analyze vendor performance regarding testing performance and regulatory compliance
- Regularly attend external seminars keeping abreast of proposed and updated legislation and communicate findings to appropriate areas for future planning
- Identify and help implement modifications to in house regulatory systems, including user acceptance testing. Involves partnership with global IT personnel
- Analyze regulatory requests regarding Producer Licensing in order to facilitate the ability of the business to bind policies in a compliant manner
- Assist in the function of being the main contact and corporate liaison to regulatory and certifying agencies
- Lead for training compliance efforts for the Bell Training Academy
10
Experience For Clin Res Regulatory Compliance Specialist Resume
- Conduct on-going needs analysis to ensure regulatory training requirements are met consistently
- Work with instructors and instructional designers in the development of training materials and training needs analysis, as needed
- Assist Sr. Training Regulatory Special in hosting external audits
- Maintain a working knowledge of all Federal Motor Carrier Safety Regulations (FMCSR) pertaining to the qualification of drivers
- Assist drivers in troubleshooting licensing issues
- Offer training to the research community on up to date compliance information issued from external funding agencies
- Act as key liaison during external funding agencies audits and implement recommendations as per audit results
- Learn our T&E products through hands-on training and reading through surgical techniques
- Participate in developing and establishing quality systems programs and plans that ensure compliance with the Quality System Regulations
List of Typical Skills For a Regulatory Compliance Specialist Resume
1
Skills For Senior Regulatory Compliance Specialist Resume
- Good PC Skills with MS Office Suite and MS Outlook
- Solid research, project management, organizational and analytical skills
- Demonstrated capacity to effectively interact with multiple levels of staff and state regulatory authorities
- Experience developing and implementing policies.Experience in conducting audits
- Use understanding of industry practice and company policies to effectively implement and improve product quality and the quality management system
2
Skills For Field Regulatory & Compliance Specialist Resume
- Strong written and oral communication abilities, including skillful negotiation
- Administrative skills, including proficiency in computer programs – Microsoft Word, Excel, PowerPoint, Outlook, and Visio required
- Solid experience and understanding of health authorities’ expectations for dossier content
- Demonstrated complaint management and MDR (medical device reporting) experience are required
- Strong experience with the application of Process Safety Management programs/requirements
- Three years of industry experience, two years of which is Regulatory Compliance/Quality Systems experience
- Effectively communicate with regulatory subject matter experts, site leadership, and other stakeholders within the organization
3
Skills For Senior Water Quality Regulatory Compliance Specialist Resume
- Proficient computer skills in MS Office applications & full command of the Internet
- Outstanding analytical skills
- Executing prioritized assessment plans, including communication of the plans to all levels of the organization
- Facilitating the development and maintenance of effective assessment protocols and test plans
- Leading the development and maintenance of effective assessment protocols and test programs
- Collaborating with related functional resources and other Compliance Team Members to identify and establish effective compliance programs, processes and tools
- Experience creating, editing, and/or evaluating work instructions
- Experience managing, organizing, and maintaining large quantities of data
4
Skills For Offshore Regulatory Compliance Specialist Resume
- Applicable experience in pharmaceutical manufacturing, Medical Device, or related industry including 1 year in Quality Assurance
- We are looking for someone with 3+ years of technical and compliance experience with manufactured products, including hardware electrical products
- FAA A&P License or equivalent. Experience maintaining training data for a cloud environment
- Knowledge of Adverse Experience processing and reporting
- Experience operating the following test equipment
- Review and analyze documents pertaining to a driver’s prior driving history, such as motor vehicle records, accident reports, and inspection reports
5
Skills For Senior Field Regulatory & Compliance Specialist Resume
- Hands-on experience with commercially-available Anti-Money Laundering transaction monitoring systems such as Mantas, SAS, Norkom, and NetEconomy
- Experience authoring/approving ANDA/NDA/510K submissions and subsequent responses to regulatory bodies/ministry of health/Food and Drug Administration
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
- Strong knowledge of Microsoft Office Products, including SharePoint
- Experience writing regulatory filings for parenteral products
6
Skills For Nutrition & Labeling Regulatory Compliance Specialist Resume
- Strong understanding of requirements for global regulatory filings (US, EU, JP, and international)
- Applied experience using MS Office Suite, especially MS PowerPoint, Word and Excel
- Experience leading internal audits is required
- Experience supporting External Health Authority and Regulatory Body Inspection is required
- Documented training in FDA Quality System Regulation, ISO 13485, MHLW Ordinance 169, RDC ANVISA 16 and Therapeutic Goods (Medical Device) Regulations
- Experience managing complex subject matter communications
7
Skills For Quality & Regulatory Compliance Specialist Resume
- Proven ability to apply systems thinking and continuous improvement concepts
- Experience with review of labels and packaging
- Experience with submitting well-related applications and reports in the Rocky Mountain region
- Experience collaborating cross functionally on the creation of gap closure plans
- Experience working directly in an RF / EMC laboratory
- Experience with ingredient compliance, safety data sheets, DOT hazardous materials shipping processes, and management of DEA controlled substances
- Validate training requirements through in-depth governmental regulations research
- Experience handling research funds both pre and post awards, an asset
- Product Complaint Handling experience in medical devices
8
Skills For Environmental & Regulatory Compliance Specialist Resume
- Solid knowledge of Microsoft Office including Outlook, Access, Excel and Word
- Experience conducting internal audits and/or supplier audits for pharmaceutical and/or medical device
- Experience authoring compliance documentation such as Annual Product Reviews (APR) and Change Control
- Experience with drug/device labeling requirements for US and international
- Experience with working with cross-functional teams
- Performs the role of the ECO change assessor for UK operations and Liege, including effective communication with R&D and change assessors at other sites
- Consolidate, coordinate and execute projects with multiple details, timelines and participating stakeholders
9
Skills For Regulatory / Compliance Specialist, Senior Resume
- Experience in filing US regulatory submissions
- Experience and expertise of Quality Regulatory Compliance system
- Experience with Regulatory Affairs
- Support process validation and/or verification activities
- Experience with leading risk based internal auditing and operational field EH&S field assurance reviews
- Experience with streamlining geospatial processes and map generation using Python or model builder
- Experience with problem solving and decision making
- Experience using integrated software applications (SAP's EHS module)
- Practical experience in global hazard communication or transportation classification within the chemical industry related to SDSs and labeling
10
Skills For Clin Res Regulatory Compliance Specialist Resume
- Possess experience appealing DOT violations and citations
- OSHA regulatory compliance experience and training
- Experience w/ ingredient compliance, safety data sheets, DOT hazardous materials shipping processes, and management of DEA controlled substances
- Experience in auditing is an advantage
- International Trade compliance experience - specifically with export rules and regulations, licensing & free trade agreements
- Experience preferably in a regulated industry
List of Typical Responsibilities For a Regulatory Compliance Specialist Resume
1
Responsibilities For Senior Regulatory Compliance Specialist Resume
- Critical thinking, problem solving, listening and communication skills (verbal and written)
- Demonstrated experience conducting audits, preferably in a regulatory environment
- Reviewing Validation Master Plans
- Maintain databases/spreadsheets for company required reporting to acknowledge priority dates
- Proven ability to build, maintain, and evolve databases and workflows for streamlined environmental compliance review
- Corporate legal/paralegal experience
- Legal, compliance, real estate or timeshare experience in an administrative function required
- Relevant experience is required, preferably in wireless technology and/or Copier Service support industry
2
Responsibilities For Field Regulatory & Compliance Specialist Resume
- Demonstrated ability to work with subject matter experts at all levels of an organization
- Demonstrated proficiency in software applications: Word, Excel, Powerpoint
- Experience in the medical device industry
- Maintain excellent working relationship with project teams and environmental consultants to move projects through the environmental process
- Prior employment with a financial institution
3
Responsibilities For Senior Water Quality Regulatory Compliance Specialist Resume
- At least two year’s experience in a similar Medical Device / Regulatory / Quality Systems environment
- Prioritize and organize multiple projects and issues
- Conducting and/or assisting with site visits, audits, and meetings, as necessary
- Working knowledge of the FD&C Act, 21 CFR, Agency guidance’s, and PHS Act. Knowledge of international regulations helpful
- Understanding of ISO 13485 requirements and EU/FDA medical device regulations
- Willing to travel 10% of the time internationally, current passport
- Meeting with clients to evaluate and develop permit-related and overall compliance program requirements
- Conducting cGMP audits of key suppliers of equipment and services
4
Responsibilities For Offshore Regulatory Compliance Specialist Resume
- Performing Quality Risk Assessments
- Understanding of Microsoft BI
- Working knowledge of Microsoft Office/Suite, Adobe Acrobat, etc
- Engaging and managing third party consultants to conduct audits and/or completing other assessment activities
- Leading and managing non-routine internal assessments in response to management concerns for internally or externally discovered non-compliance issues
- Assist international product registrations by collecting and collating supporting documentation required for CFG requests and submitting
- Work involves regulatory responsibilities in the following areas: Welding, Corrosion, OQ, PA, IMP, Denbury Engineering Standards and Security Management
- Significant input into system development, including assisting with the firm’s implementation of its regulatory solutions offerings with clients
5
Responsibilities For Senior Field Regulatory & Compliance Specialist Resume
- Assist in the development and writing of the clinical trial protocol and other study specific documents including but not limited to: consent forms, case report forms, investigator’s brochure, recruitment materials, training slides, visit checklists, Standard Operating Procedures (SOPs), guidance documents, study manuals, etc
- Serve as a key Zoetis Establishment 190 representative to USDA (USDA liaison) & international regulatory colleagues and agencies regarding compliance activities for Charles City Operations
- Monitor regulatory communications & assure that any commitments to the agencies are endorsed by leadership and communicated. Ensure commitments are met and/or communicate progress to the CVB
- Ensure in-line product Outlines of Production are compliant with contemporary USDA standards, 9 CFR 114 and VS Memorandum 800.206. Coordinate the compliance of the Outline templates with VMRA and Lincoln Regulatory Compliance and site personnel
- Manage the Annual Outline of Production review process and ensure that all outlines are reviewed within the timelines. Coordinate any changes identified in the annual review process with planned registration changes
- Major Repair and Alteration reporting evaluation, recording, and FAA submission.
- Compliance oversight for clinical trials; monitoring or auditing of studies
- Read and interpret engineering schematics/drawing/prints
- Be able to communicate with Engineering to understand how something works or to understand the lingo
6
Responsibilities For Nutrition & Labeling Regulatory Compliance Specialist Resume
- Maintain controlled substance and listed chemical files (shipping, receiving, Form 222, ARCOS, correspondence, destruction)
- Responsible for ensuring records (e.g., Master Batch Records, etc) and SOPs pertaining to controlled substances are accurate and complete
- Run regular reports related to processing work requests and maintaining the bird site database
- Perform training for in-house and field personnel on PI submission, MDR reporting, and recalls
- Light lifting and bending
- Aid in developing and executing process and product protocols and reports
- Aid in developing statistical process controls and analyzing data
- Coordinate obtaining medical opinions in support of reporting and investigational purposes.
- Understand and evaluate formula and regulatory changes using a global database
7
Responsibilities For Quality & Regulatory Compliance Specialist Resume
- Document decisions and communicate findings appropriately to stakeholders (i.e Legal, Marketing, and R&D)
- Establish interaction with colleagues with regard to matters concerning international projects and import/export
- Create processes to automate map generation and spatial analysis using Python and model builder
- Modifies existing guidance documents based on changes in regulations
- Assist in data management including RoHS and other material compliance requirements
- Monitor EASA and other NAA regulatory bodies including DOD
- Liaison with FAA concerning airworthiness regulation compliance issues.
8
Responsibilities For Environmental & Regulatory Compliance Specialist Resume
- Coordinates with aircraft engine manufacturers, lessors and owners during periodic records audits.
- Assist in providing information & consultation for inquiries & requests related to product safety
- Assist with support, consultation and training of related groups and divisions for regulatory compliance, and inquiries & requests related to product safety
- Enter and process BU's request for product safety item set up in S21 system on a daily basis, ensuring accuracy
- Follow up with Business Units on obtaining the proper documentation for S21 safety data entries
- Monitor pilot and maintenance training records in accordance with regulatory authority requirements
- Conduct annual regulatory requirements training
- Partner with functional business leaders to incorporate Bell’s process changes into training materials
9
Responsibilities For Regulatory / Compliance Specialist, Senior Resume
- Coordinate with Sr. Training Regulatory Specialist to monitor classes and report student completions and status of compliance to senior management
- Monitor and review company activities to assess level of compliance with existing and proposed federal, state or industry legislation and regulations
- Enter Hydrocarbon Sales and Balances in NGL’s Ticketing System (TTS)
- Analyze and understand technical and scientific documents, and governing regulatory research information and data, attentive to details and to consistency
- Able to generate high quality maps which meet company standards using ArcMap and various add-on applications
- General knowledge concerning industry codes, standards, and practices as well as regulatory requirements is desired
10
Responsibilities For Clin Res Regulatory Compliance Specialist Resume
- Familiarity with database software, electronic protocol systems, and web publishing software
- Inquisitive; quick and avid learner; enjoys exploring new challenges
- Excellence-driven; willing to go the extra mile
- Thorough understanding of DOT regulations
- Knowledge of regulatory procedures and government practices pertaining to drug, and device development processes
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