Regulatory Manager Resume Samples

A Regulatory Manager specialized in making sure that the company operates safely and ethically. Working in a variety of industries, these managers fulfill the following duties mentioned on the Regulatory Manager Resume – submitting compliance reports to regulatory organizations, performing internal audits on the effectiveness of compliance policies, serving as a liaising between the management and personnel, creating and maintaining files of investigation results and complaints, collaborating with corporate lawyers on compliance issues and providing management with progress reports. Other core duties include – assisting with the creation and implementation of cost-saving methods and financial activities like contracts, invoices, and reporting.

Such Managers are expected to stay abreast of current industry trends, regulations, and compliances. Other crucial traits include strong problem-solving skills, project management abilities, and the ability to foster a culture of organizational safety and educate staff on applicable regulations. Individuals might need a degree in business, finance, or economics to work as a Regulatory Manager.

Regulatory Manager Resume example

Regulatory Manager Resume

Summary : Over 25 years experience in the Oil Gas Industry with in-depth knowledge and understanding of GOM/West Virginia/Ohio regulatory issues and additional experience in environmental and safety. Responsibilities include identification and interpretation of regulatory requirements, liaising with regulatory agency personnel, preparation, submittal and management of necessary plans, permits and applications for drilling, production, and development.

Skills : PowerPoint, GraphPad Prism. Excellent organization, presentation, and editorial. Some exposure to grant writing/editing and regulations of human research.

Description :

    1. Responsible for overseeing Adult Hematology & Oncology regulatory staff and 160+ protocols, in order to ensure all deadlines and trial initiation requirements are met.
    2. Managed all Investigator-Initiated Phase I Trials.
    3. Collaborated with Protocol Writer to ensure IIT protocol development is complete and compliant, with special attention to eligibility, study management, and safety reporting sections.
    4. Ensured consent document financial information matches local Medicare Coverage Analysis.
    5. Submited Initial IND Application and Annual Reports, the latter complete with adverse event information for participants to date.
    6. Managed quality assurance measures to ensure safety reporting is complete and fully documented for monthly DSMC meetings.
    7. Organized internal Site Initiation Visits for IITs, including slide preparation and training documentation.
Years of Experience
Experience
7-10 Years
Experience Level
Level
Management
Education
Education
Bachelor Of Science


Regulatory Manager Resume

Objective : To apply my knowledge of FDA Good Clinical Practice guidelines/ICH guidelines, extensive site/field Clinical Director, Site Lead Study Management, in addition to my experience with various therapeutic areas of medicine, to a position as a Clinical Research Associate.

Skills : Regulatory affairs, Drug Safety, Patient Care & Interaction.

Description :

    1. Supervise all staff members in the patient care setting.
    2. Responsible for hiring, evaluation, discipline and firing.
    3. Supported budget and contract negotiation with investigational sites, as applicable, at their assigned sites; ensures payment for services.
    4. Ensured recruitment strategies in place to meet study needs, including patient enrollment targets at their assigned sites.
    5. Managed existing sites and develops new clinical investigator sites to meet Sponsor projected patient recruitment needs.
    6. Monitored site quality and performance (metrics).
    7. Developed solutions to optimize performance.
Years of Experience
Experience
2-5 Years
Experience Level
Level
Executive
Education
Education
M.B.A. In Corporate Finance


Regulatory Manager Resume

Summary : Over 10 years of regulatory compliance experience with county, state and federal regulatory agencies. State agencies include: COGCC (Colorado), WOGCC (Wyoming), UDOGM (Utah), TXRRC (Texas). Federal agencies include: BLM, US Forest Service (USFS).

Skills : Planning Skills, Computer Skills.

Description :

    1. Served as the UBO system matter expert on all issues surrounding charging, billing and collections Provided feedback to management (including the HIM Directors, Chief Financial Officers & Hospital Admissions) and facilities on insurance verification and admission errors.
    2. Reviewed unbilled reports and followed up with facilities' and HIM Director's to resolve.
    3. Monitored claim submission error reports from HMS billing module, third party clearinghouse and on-line insurance tools.
    4. Managed accounts receivables.
    5. Assigned/allocated resources as required to ensure company goals for aging and accounts receivable days are met.
    6. Identified and reported accounts receivable trends to management Ensured that all new/updated Medicare & private insurance reimbursement codes are made available to billers & collectors and updated on applicable UBO software.
    7. Ensured Medicare bad debt logs were maintained.
Years of Experience
Experience
10+ Years
Experience Level
Level
Senior
Education
Education
BA In Management

Regulatory Manager Resume

Objective : Compliance Regulatory Manager professional experienced with government regulations and compliance issues including hazardous waste incidents and emergency planning.

Skills : Regulatory Affairs, Analytical / Research, Real Estate Sales, International Registration, Project Management.

Description :

    1. Supervised and mentored regulatory team to ensure compliance with state and federal regulatory and statutory requirements including county and municipal agencies.
    2. Oversaw company's DOT random drug and alcohol program.
    3. Managed field and pipeline inspections in adherence to BSEE, BOEM, DOT, EPA, GLO, PHMSA and USCG compliance.
    4. Prepared and submitted emissions calculations for onshore and offshore facility air permits.
    5. Reviewed and revised SPCC, OSRP, DPRP & TOM plans.
    6. Communicated regulatory information to multiple departments to ensure that information was interpreted correctly.
    7. Organized and maintained reporting tools to keep management regulatory apprised of trending compliance tasks and potential challenges.
Years of Experience
Experience
2-5 Years
Experience Level
Level
Executive
Education
Education
GED

Regulatory Manager Resume

Headline : Regulatory Manager experienced in all aspects of clinical research trials, including protocol review and input, document creation, tracking / documentation, budgeting, and investigational product (IP) management. Maintain current knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines for clinical research.

Skills : MS Project, Planning Skills.

Description :

    1. Wrote notifications in accordance with FDA CFSAN and Health Canada requirements for regulatory submissions.
    2. Collaborated with key stakeholders, collecting and compiling needed components and scientific content for initial regulatory submissions, and responding to and addressing FDA and Health Canada follow up questions.
    3. Composed FDA and Health Canada notifications and compiled proper attachments in accordance with requirements that facilitated clearance for 15 infant formulas.
    4. Maintained Regulatory Filing System for all regulatory submissions and associated communication.
    5. Oversaw Serious Adverse Event management and submission to FDA.
    6. Compiled and reviewed all information.
    7. Obtained needed information by communicating with call center personnel.
Years of Experience
Experience
5-7 Years
Experience Level
Level
Executive
Education
Education
BS

Regulatory Manager Resume

Objective : Obtain a challenging leadership Regulatory Manager position applying creative problem solving and lean management skills with a growing company to achieve optimum utilization of its resources and maximum profits.

Skills : Managing Skills, Developing Skills.

Description :

    1. Monitored government regulations affecting the business and the legislative process.
    2. Researched and interpreted federal and state regulations.
    3. Developed and implemented regulatory requirements, policies, and any supporting position paper and rationale documentation as needed by client groups.
    4. Assisted in development, implementation and evaluation of process and procedures to ensure compliance with regulations.
    5. Provided regulatory support to functional areas.
    6. Participated in process improvement working groups.
    7. Represented External Affairs Regulatory team in work groups and projects, as assigned.
Years of Experience
Experience
2-5 Years
Experience Level
Level
Executive
Education
Education
BA In Broadcast Journalism

Regulatory Manager Resume

Objective : Highly organized and goal-oriented with proven success at managing multiple projects simultaneously within a fast-paced and challenging environment. - Possesses excellent analytical abilities, learns quickly and works well independently or as a team player.

Skills : Multitasking, Coordinating Skills.

Description :

    1. Ensured compliance with all federal, state and local regulations pertaining to human subject research, including the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver, and other pertinent regulatory agencies.
    2. Provided comprehensive regulatory management for more than 90 clinical trials for the GI/Hepatology Department, including investigator-initiated and industry-sponsored studies.
    3. Served as regulatory contact person for ongoing clinical research studies and meet with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records.
    4. Relay timely information regarding protocols to all appropriate clinical staff to ensure compliance with the protocol and all applicable internal and external regulations.
    5. Maintained continuous communication with regulatory committees and sponsors prior to and during the protocol development and approval process, and ensure proper communication and follow up.
    6. Prepared, submitted, and maintained all Colorado Multiple Institutional Review Board (COMIRB) and Western Institutional Review Board (WIRB) submissions for full board, expedited and exempt trials, including initial applications, amendments, continuing reviews, and trial closures.
    7. Developed and negotiated clear and accurated informed consent documents and HIPAA (Health Insurance Portability and Accountability Act) Authorizations.
Years of Experience
Experience
2-5 Years
Experience Level
Level
Executive
Education
Education
Master Of Science In Public Health

Regulatory Manager Resume

Summary : Capable Regulatory Manager with a 21-year record of success in executive management and supervisory positions with 6+ years in the oil and gas industry. Outstanding clerical and administrative skills. Coordinated with the Colorado Oil and Gas Conservation Commission in relation to the operations and permitting process in the (Uinta-Piceance Basin, Province 5020 (Province 20).

Skills : Training Skills, Writing Skills.

Description :

    1. Responsible for regulatory reporting to the Texas Railroad Commission with management and compliance.
    2. Worked on a daily basis with the Texas Railroad Commission on obtaining the required necessary permitting.
    3. Responsible for obtaining licenses and permits as well as keeping complaint on current publications and press Releases.
    4. Permitted wells with the Railroad Commission of Texas, R.W.
    5. Byram and Company and the Texas Commission on Environmental Quality.
    6. Coordinated with city officials, engineers and surveyors to execute deadlines on inside of the city limit permitting.
    7. Wrote review summaries.
Years of Experience
Experience
10+ Years
Experience Level
Level
Senior
Education
Education
Business Management Technologies

Regulatory Manager Resume

Summary : A highly motivated, results-driven professional with over 16 years of experience in FDA-regulated industries. Possess a strong engineering background with an MBA degree and PMP certification. Able to adapt quickly to changes and take on new responsibilities. Experienced in project management, product launch, operations, financial analysis, Phase I - III clinical trials, NDA submission planning, and business strategy.

Skills : Microsoft Office, Jd Edwards, Adobe Acrobat.

Description :

    1. Regulatory Manager Involved in preparing the initial documentation to IRB and follow-up regulatory documentation for over 50 clinical trials.
    2. Assisted and communicated with other senior staff to ensure appropriate coordination of clinical trials.
    3. Maintained charts.
    4. Oversaw the preparation of all closed study files for archiving in storage.
    5. Formed and maintained strong working relationships with staff and external customers (i.e., Physicians, IRB, etc.).
    6. Performed other duties as needed to support the company.
    7. Prepared and collated materials stored in the regulatory binder including all pertinent regulatory documents, correspondence and approved documents.
Years of Experience
Experience
10+ Years
Experience Level
Level
Senior
Education
Education
BS In General Studies

Regulatory Manager Resume

Summary : Seeking a position as Regulatory Manager, Ability to communicate, teach and interact with all levels within the corporation. Developing, planning and implementing training courses and materials. Overseeing product launch from start to follow up completion. Organized, detailed, excellent computer skills.

Skills : Microsoft, Excel, Excel, Office Management, Oil & Gas, Regulatory, Regulatory.

Description :

    1. Maintained and performed internal quality assurance of regulatory binders.
    2. Provided leadership in areas of federal and state student aid regulation.
    3. Developed and maintained collaborative working relationships between External Affairs and client group partners/stakeholders.
    4. Participated in professional organizations and events to foster relationships.
    5. Evaluated in context of FDA reporting requirements, including composing manufacturer's assessment.
    6. Wrote cover letter and completed CIOMS / MedWatch forms to FDA and managed all relevant correspondence and document archiving.
    7. Responded to notices of potential non-compliance to ensure timely resolution.
                        Years of Experience
                        Experience
                        7-10 Years
                        Experience Level
                        Level
                        Management
                        Education
                        Education
                        MS