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6-10 years of experience
Responsible for EU/USA specifications with EU/USA labeling data flavors and finished food concepts, EU/USA MSDS, allergen data, natural status, TTB, Kosher certificates, Halal reviews and finished products labeling and nutritional data. Main contact for all patent pending technology and the completion of documentation for all high end value customers.
- Maintained finished goods data/labels in SAP system for all plant sites (neat chemicals and finished flavors), entered and maintained MSDS documents/allergen data and updated nutrition information.
- Provided standard and customer specific documents for key customer accounts and researched the issues surrounding the legislative status of formulae.
- Decreased document turnaround time on new formula requests by streamlining the request process and implementing request assignment and completion policy.
- Participated in site-specific weekly early warning meetings, reported on vendor issues and secured agreement with specialty chemical site on the status of EU Natural raw materials.
- Championed [company name] position on topics regarding allergens, bioengineered ingredients, organic status, generally recognized as safe, and Natural.
- Assisted in the successful transfer of one manufacturing site from manual to SAP ERP system.
0-5 years of experience
Regulatory Specialist tasks included managing the maintenance and organization of over 300 pieces of equipment necessary for daily blood drives; including performing and thoroughly reviewing yearly, monthly, and weekly preventative maintenance work orders in accordance with current good manufacturing practices. It was also crucial to work closely with drive supervisors, account managers, staff, and equipment specialists to ensure that the eight teams and fixed site had enough functioning equipment to successfully complete a blood drive.
- Eliminated time and organizational issues at secured collection sites by implementing a system to ensure the correct equipment was documented and sent with staff.
- Performed thorough review of work orders completed by staff to identify and correct errors that may have compromised patient safety, produced problems, and/or incurred a fine from the FDA.
- Completed time sensitive preventative maintenance work orders on time to ensure equipment was in date, functioning properly, and 100% compliant with FDA and AABB regulations.
- Facilitated efficiency of non-routine maintenance for equipment by contacting vendors and scheduling maintenance activities, assessing and performing small repairs to save the company money, sending units to and receiving units from the equipment management group, and redistributing equipment to teams in a timely manner.
- Provided support to staff performing weekly download activities by troubleshooting computer issues, coordinating communication with regional IT services, and performing download activities for absent staff and computers back from repair.
0-5 years of experience
- Responsible for cost development and rate design for wholesale operations and retail cooperatives.
- Prepared wholesale cost study and testimony as a professional witness in state revenue requirement proceedings.
- Managed rate cases, including the disposition of interrogatories and the preparation of depositions.
- Assisted in the development of the rate designs for 11 retail electric cooperatives.
- Developed and implemented training for retail electric cooperatives on cost and rate design.
- Responsible for state compliance filings and reporting.
0-5 years of experience
- Assessed and assured that offenders within the State correctional system receive healthcare as mandated by federal and state law and national standards
- Coordinated compliance with the Memorandum of Agreement with the Department of Justice including preparing for, participating in and responding to Federal monitor visits, drafting compliance reports for publication and communicating regularly with all involved parties
- Facilitated efforts to improve operational compliance within the correctional facilities
- Oversaw vendor’s Continuous Quality Improvement Program
0-5 years of experience
- Analyzed complex data and communicated results verbally and in writing
- Advised practitioners of most optimal avenues to attain state licensure
- Maintained position as a Top Three Performer in monthly metrics reports
0-5 years of experience
- Developed and implemented 10+ investigator initiated trial protocols and 7 single patient Investigational New Drugs (INDs) in the last two years
- Leading a team of 3 regulatory specialists to activate and manage over 90+ clinical trials in the field of breast, genitourinary (GU) and head & neck oncology sponsored by top 10 global pharmaceutical companies
- Interface with regulatory authorities and sponsors throughout the clinical trial to ensure compliance to FDA related and Good Clinical Practices (GCP) regulations in conduct of clinical research at the cancer center, affiliated sites and external sub-sites
- Develop study timelines for rapid activation of clinical trials
- Training and mentoring new hires and research community on regulatory policies and institutional procedures
0-5 years of experience
- Responsible for reviewing labeling and promotional material for FDA compliance program.
- Presented “what if†scenarios for budget assumptions and forecasting strategies.
- Budgeted active and proposed projects by accurately determining pricing, margins and risk factors.
- Reviewed and analyzed project spending throughout project life cycle.
- Consolidated financial data and materials for key leadership meetings.
- Implemented a set of comprehensive tracking processes to monitor cost performance.
- Directed all phases of production projects, from pilot order to commercial orders.
0-5 years of experience
Prepped, scanned, indexed and coded applications into the system once received into the department.
- Knowledge of License Ease, Microsoft Office & Windows.
- Reviewed curriculum, transcripts, degrees and other educational materials of applicants having received educational training.
- Operated photocopying machines, typewriters, calculator, mailroom machinery, computer terminals, microfilm and microfiche readers and related equipment with such accuracy as can be acquired on the job and other related duties assigned.
- Responsible for answering incoming and conducting outbound calls to new and existing customers regarding business license.
0-5 years of experience
- Approved import permits for biologics and Class IIa & IIb medical device products following FDA, USDA, CBP and CDC regulations.
- Resolved master data issues to create multiple master project lists for the department.
- Organized and filed documents following Abbott’s corporate document retention policy.
0-5 years of experience
Study Start-up and IRB submissions
- Assisted clinic manager in budget negotiations
- Set-up and maintained regulatory files performing regular internal audits
- Maintained and prepared documents for submission to Contract Research Organizations and regulatory agencies
- Acted as point of contact for CROs and sponsors
- Active in site selection and initiation process
- Created study specific source documents
- Conducted study visits
- Resolved queries within various data entry programs
- Collected and processed samples.
0-5 years of experience
Prepare, review, and finalize reports, labeling and other documents for formal submission to regulatory agencies
- Consider suitability of documentation for regulatory filings, identifying gaps as compared to relevant
- Organize key project information and track activities along project plans
- Develop and maintain knowledge of regulatory requirements and current industry practice for regulatory submissions
- Assist in maintaining state, federal and international licenses, registrations and listings
0-5 years of experience
Prepare and submit FDA regulation documents for Pharma.
- QC regulatory documents for 50+ employees to ensure they meet FDA standards.
- Train all new employees on systems and FDA standards.
- Lead 10 employees on SalesForce driven project including distribution of materials.
- QC of all information being submitted by employees for SalesForce.
0-5 years of experience
- Process Identity Theft complaints from Florida customers within the Driver License Fraud Department at the DHSMV. This entails researching driver records, contacting victims via phone/email, and adjusting a customer’s record according to the investigation.
- Maintain professionalism and confidentiality while answering incoming calls from the public and Tax Collector employees. This consists of research and proper advising of fraud protocol in order to proceed with in-office issuances.
- Investigate and follow up on written disability placard/space complaints.
- Complete all assigned work within a 24-48 hour turnaround time and assist section members with projects when necessary.
- Keep records of all work, correspondence and phone calls within an Excel spreadsheet on a weekly/monthly basis.
0-5 years of experience
- Offer technical and scientific guidance to Marketing and Regulatory attorneys
- Facilitate the development of 3 new Global Quality Assurance corporate policies and procedures
- Execution of product recalls and internal retrievals with organized
- Utilize “Team Center” software to assess primary and secondary packaging artwork for cosmetic and OTC drug products for global compliance against company labelling guidelines
- Support Quality Assurance on FDA 483 response letters and appropriate closure of CAPAs
0-5 years of experience
- Secretarial /administrative work that requires advanced communication and secretarial skills.
- Monitors and performs accurate indexing, scanning and quality control of investigative. documents and case files. Review case preparation and processing.
- Ensuring deadlines are met and cases are processed in accordance with internal timeframes.
- Maintain work assignments, production and work flow.
0-5 years of experience
- Preparing and managing all of the Regulatory documents for the [company name] Lakeland Production Facility.
- Answering all Regulatory related customer questions for [company name] Lakeland products.
- Submitting products for TTB approval
- Handling all Certifications for [company name] Lakeland products.
- Handling Tariff Classifications for Citrus, Dry Blend and Syrup Products
0-5 years of experience
- Ensure compliance to industry regulations, programs, policies and procedures.
- Establish and maintain business and contractual relationships with external stakeholders.
- Oversight of regulatory inspections, allegations and plant performance evaluations.
- Conduct internal and external analysis and assessments.
- Led multi-million-dollar integration project to include gap analysis, scheduling and monitoring 24,000+ tasks, and communicating performance metrics.
0-5 years of experience
- Authored Safety Data sheets and other documentation in compliance with U.S and EU regulations.
- Reviewed all incoming raw materials for safety and compliance for use in manufacturing and finished good compliance.
- Provided technical support for company wide project to update labels for compliance with GHS/CLP requirements.
- Trained new staff on WERCS database applications.
- Provided guidelines and support to call center for responding to product safety questions.
- Supported chemical registration in international markets as needed.
0-5 years of experience
- Set up weekly surveyor work on Outlook calendars for surveys of health care and residential facilities to determine compliance with State and Federal regulations
- Read surveyor work returned to office for accuracy to applicable regulations and documentation necessary to ensure facilities are in compliance with current regulations per CMS
- Ensure all duties and responsibilities related to facility surveys are completed from initial to final action
- Prepare applicable reports based on proper POD for CMS reports and facility letters upon completion of visits
- Any and all duties given by Field Office Supervisor and Nursing Supervisor as needed to effectively keep surveys timely
0-5 years of experience
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or other interested parties.
- Author and maintain Safety Data Sheets (SDS) for all offered products.
- Renew pesticide registrations for state, federal, and international bodies.
- Review labeling and labels for compliance with regulatory requirements.
- Manage laboratory safety and hazardous materials handling for R&D laboratories.
- Develop the Chemical Hygiene Plan (CHP) for the Aurora facility laboratories.
- Determine proper shipping classifications for products according to multiple countries regulatory agencies such as DOT, ADR, IATA, IMDG, and TDG
0-5 years of experience
- Provide applicants and potential applicants personal guidance regarding certification and licensure.
- Review documents for authenticity, legality, appropriateness of education and practice.
- Performs other related work as required to maintain an efficient office, including responding to the needs of applicants, licensees and other areas.
- Research and reference laws and rules regarding licensure, examination, and renewal and continuing education requirements related to health care practitioners.
0-5 years of experience
- Analyze various State regulations to determine the relevance to business lines.
- Validate the integrity of current compliance policies and procedures by overseeing periodic compliance state reviews.
- Develop and review the results of self-audits with the business units. Correct process deficiencies uncovered by audits.
- Interface with Corporate Compliance during bank examinations by serving as a principal source for gathering information from the business line as necessary to respond to examiner inquiries.
0-5 years of experience
- CIP review
- Verified clients newly opened and transferred Mutual Fund accounts for accuracy of data elements via Lexis Nexis, Citrix and FSR record keeping system.
- Phone and letter contact made to clients and brokers if a discrepancy is found, requesting verifying documents
- Scanned received documents into image system, made any necessary corrections in FSR to update shareholders’ information
- Processed audit reports as requested by the Mutual Funds
- Filed Suspicious Activity Reports (SARS)
0-5 years of experience
- Create original submission dossiers and maintain domestic and international registrations of pesticide, rodenticide, and cleaner/disinfectant products, adhering to strict timelines as dictated by PRIA and other schedules.
- Create and maintain Federal Section 3, and Section 24(c), 2(ee) and other specialty pesticide labels, including notifications and amendments.
- Create and file annual Pesticide Establishment Report, FIFRA 6(a)(2) Incident Reports, Export Report, and any other data requirements from the various authorities.
- File and maintain state registrations for pesticide, rodenticide, and cleaner/disinfectant products.
- Compile and maintain regulatory documentation databases, systems, and status reports for general access and for distribution to corporate leadership.
- Coordinate efforts associated with the preparation of regulatory documents or submissions with private label companies or supplemental distributors; serve as regulatory liaison with partner companies in Central and South America and in Canada.
- Proofread and review product promotional materials and labeling for compliance with FIFRA, and any applicable international regulations.
- Create domestic material safety data sheets in 16-section ANSI format.
- Develop and conduct employee regulatory training at multiple sites.
- Write or update work instructions and manage appropriate trainings and serve as Document Control for ISO functions.
0-5 years of experience
Serve as primary contact for principal investigator and research staff related to regulatory specific issues.
- Responsible for submitting proposals to CDH office of research support and the IRB
- Facilitates investigator and research team compliance with fiscal and regulatory obligations
- Performs liaison activities with the CDH IRB
- Communicates with the study coordinators regarding any changes to protocols/consents
- Prepares documentation submissions to the CDH IRB, study protocol applications, amendments and continuing reviews, and safety reporting
- Complies and submits all sponsor documents to adhere to regulatory requirements and requirements of sponsors
- Develops and delivers training in new regulations and policies to researchers as they relate to IRB/regulatory components of research
- Maintains all NCI investigator paperwork for all CDH Cancer Center investigators
- Performs internal trial audits on regulatory aspects of clinical trials; report’s findings and delivers corrective action plan to researchers and their team
0-5 years of experience
- Currently use Microsoft Excel, Outlook, Word, Access on a daily basis for business needs
- Review, interpret and coordinate with all clients for regulatory approval of exports and Imports.
- Current on all government regulations and changes
- Direct correspondence and follow up with Clients
- Perform special safety projects as assigned by client
- Assist with FIFRA registrations and sample coordination
- Assist with GHS classifications
0-5 years of experience
- Support and maintain Contact Direct database
- Update database and client accounts with current information posted by FDA
- Develop reports and custom requests for users
- Direct inquiries to appropriate compliance specialist
- Organize and communicate department tasks with managers
0-5 years of experience
- Responsible for providing regulatory assistance to the BioNutrient business unit
- Create Technical Data Sheets for Beverage, Sweet, Savory and BioNutrient business units
- Create SDS documents based on GHS standards for US and EU
- Partner with IT to verify GHS calculations are correct
- Communicate with EHS director to validate information on the SDS
- Troubleshoot GHS SDS calculations and invalid information
- Network with IT to troubleshoot and develop efficient ways of completing daily tasks
- Partner with other specialist within the department to complete tasks efficiently and effectively
0-5 years of experience
- Develop master label manuscripts for dietary supplements and sports nutrition products due to formula revisions, marketing requests and latest nutrition research
- Reviews product documentation to ensure accurate and compliant labeling adhering to federal regulations
- Evaluate bulk formulations to verify label claims and ingredient compositions
- Interprets regulations, guidance documents and developments in the regulatory environment
- Manages projects within the department to ensure compliance and completion
- Provide and develop training material for on-boarding of new employees
- Ensure FDA and DSHEA compliance across all brands domestically
- Reviews master label manuscripts created by specialists to ensure accuracy and compliance
- Maintain brand templates for consistency across entire product portfolio
6-10 years of experience
- Maintain regulatory regulations and licensing with EPA, Health Canada, the EU and FDA for medical devices, pharmaceuticals, and pesticides
- Lead external audits (FDA, BSI, EPA, Board of Pharmacy, customer audits, etc.)
- Interact with customer service to provide regulatory information in order to satisfy customer requests
- Perform quality data trending and present monthly quality reviews
- Manage quality processes, including CAPA, change control and material nonconformances
- Train on quality processes based on updated regulatory requirements and updated procedures
- Assisted in the implementation of an updated quality system
- Perform internal audits
- Create and update quality procedures
- Review and approval of batch records, qualifications, design files, stability protocols, and procedures
0-5 years of experience
- Experience working with Verizon, AT&T and Sprint projects.
- Review Real Estate and Construction Contracts between clients and private landlords, commercial businesses or municipalities.
- Draft Leases, Amendments, Title Memorandums for Macro and Small Cell New Site Build Projects.
- Negotiate Ground Lease and New Construction terms with private landlords, commercial businesses or municipalities.
- Negotiate Lease Agreements with MLA and non-MLA property owners for Modification projects.
- Identify Zoning and Permitting Requirements for various districts in the Midwest and California.
- Complete Zoning Submittals to jurisdictions around the Midwest and California including attending Public Hearing.
- Manage small team of zoning and real estate specialists for Emerging Technologies Project.
- Research and Develop Candidates for Macro and Small Cell New Site Build Projects.
- Work with Regulatory Entities to ensure regulatory requirements are met for jurisdictions in regards to new Construction Builds.
Regulatory Specialist Duties and Responsibilities
Regulatory specialists perform varying daily duties, depending on the size of the company they work for and the compliance issues that exist within that company. However, there are several universal job tasks that are essential to this career in all business environments:
Assess Protocols Regulatory specialists assess all company protocols for compliance with city, state, and federal laws.
Revise Policies Regulatory specialists analyze company policies, making revisions to these policies where necessary.
Assess Risk Regulatory specialists perform a risk assessment of all company policies and practices.
Audit Company Processes Regulatory specialists audit company processes and protocols to find flaws and fixes.
Write Reports Regulatory specialists write detailed reports on problems found within a company and send these documents to the appropriate government agencies, such as the FDA, FTC, or EPA, when necessary.
Maintain Licensing Regulatory specialists manage company license renewals and registration paperwork to keep companies compliant.
Brief Administrators Regulatory specialists stay up-to-date on regulatory code changes, briefing company administrators and executives on these changes to help them maintain regulatory compliance.
Regulatory Specialist Skills and Qualifications
Regulatory specialists use analytical skills to assess company policies and monitor all compliance issues, writing risk assessment reports where necessary. Employers seek out regulatory specialists who have the different skills needed to perform their regular job tasks.
- Analytical ability – regulatory specialists perform assessments and evaluations
- Communication – regulatory specialists work in a collaborative environment and provide verbal and written reports
- Attention to detail – because regulatory specialists are responsible for maintaining compliance and staying up-to-date on regulatory policies, employers look for individuals who maintain strong attention to detail to fill this role
- Time-management – regulatory specialists use time-management skills to prioritize work tasks and meet deadlines
- Organization – regulatory specialists manage multiple work tasks, file reports, and analyze a lot of data
- Computer skills – regulatory specialists write reports using software programs and analyze digital files
Regulatory Specialist Education and Training
Some employers require regulatory specialists to have a bachelor’s degree in business management or a related field, but the vast majority of employers accept candidates who have a high school diploma or equivalent in addition to relevant work experience. For some employers, an associate’s degree will suffice in place of past work experience. Training is offered to newly-hired regulatory specialists. This training period varies by company and by candidate, depending on how much education and/or experience the candidate has already acquired. During training, regulatory specialists work under the close supervision of a senior regulatory specialist or a compliance manager.
Regulatory Specialist Salary and Outlook
Detailed job data from the Bureau of Labor Statistics (BLS) show that financial examiners earned a median salary of $81,690 annually and $39.28 hourly in 2017. Financial examiners occupied more than 50,000 jobs in 2016, a number the BLS expects to grow by 10 percent through 2026. This rate is faster than the national job growth average. Like regulatory specialists, financial examiners ensure compliance with laws, review data, and assess company management practices. According to data provided by PayScale, regulatory specialists earn $55,914 median annual income. Typically, regulatory specialists receive full benefits packages from employers that include healthcare insurance with dental and vision insurance. Retirement planning and life insurance are usually included in these benefits packages. Paid holidays, sick days, and vacation days are also provided by employers. Some companies offer additional perks, such as continuing education reimbursement.
Helpful Resources
Use these resources to find jobs, workplace strategies, information, and career tips for regulatory specialists:
Society of Corporate Compliance and Ethics – This website for professionals in the compliance industry, which includes regulatory specialists, provides job listings, certification program information, upcoming event dates, and resources containing press releases and compliance-related content.
The New Era of Regulatory Enforcement: A Comprehensive Guide for Raising the Bar to Manage Risk – This book was written by experts to provide a framework for regulatory specialists working in the modern world. The text includes information about the challenges regulatory specialists face and how to manage them.
Regulatory Affairs Professionals Society – Find news and articles for regulatory specialists on this website, which also provides event dates, information about training programs, research resources, and job openings.
The Regulatory Craft: Controlling Risks, Solving Problems, and Managing Compliance – This book was written for regulatory specialists to provide information about risk control, solving problems, and how to manage the daily tasks these professionals must perform.
Ethics & Compliance Initiative – Find resources and research information on this website designed for all ethics and compliance professionals, including regulatory specialists.
Regulatory Crisis: Negotiating the Consequences of Risk, Disasters and Crises – Find out how to manage disasters in the regulatory profession with this book that provides tips and strategies for managing problems and risks.
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[Regulatory Specialist]
Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
