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regulatory manager resume example with 11+ years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
:
Professional Summary

Dedicated professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

Skills
  • Clinical Trials Protocols
  • Training
  • International Regulations
  • Regulatory Policies
  • Employee Development
  • Audits
  • Clinical Development
  • Product Information
  • Regulatory Agency Applications
  • Project oversight
  • Standard operating procedures
Education
Wakefield High School Wakefield, NE Expected in 05/1999 High School Diploma : - GPA :
Certifications

GCP

Work History
Abbott Laboratories - Regulatory Manager
Georgetown, TX, 06/2020 - Current

I began my career at Meridian Clinical Research as a Clinical Research Coordinator, six months later I became an Embedded Regulatory Specialist and in March of 2022 accepted a Regulatory Manager role. I keep all studies at my site inspection ready and have successfully created and implemented processes with the clinical side to provide support to CRC's and Site Management. I was then asked to assist implementing the processes at four other sites. I am familiar with IRB's (Advarra, WCG, VivaVault), document share platforms ( GoBalto (Activate), FireCrest, LongBoat, DrugDev) and have extensive experience with the eRegualtroy system Complion. I have an excellent understanding of ICH GCP Guidelines, and am GCP certified.

  • Performed and documented quality control checks to maintain compliance with company initiatives.
  • Recommended improvements to processes.
  • Trained staff in regulatory policies or procedures.
Trio Healthcare - Administrator
Portsmouth, VA, 01/2020 - 06/2020

I oversaw operations for two RTF/HAB homes for severely mentally ill individuals. I was charged with ensuring Federal and State compliance of day to day operations. Some Duties: Ensure Adequate staffing for both facilities as well as staff training, covering shifts when needed; transporting residents to appointments; keep resident healthcare and disability documentation up to date as well as conduct timely assessments. All food ordering and some menu planning for the facilities; track budget; plan activities; teach residents. This position I would have kept longer had the pandemic not happened. After working 22 hours straight one day, I decided to move on.

  • Completed forms and reports to facilitate admission, transfer or discharge.
  • Oversaw successful planning and execution of staff meetings, parties and events.
  • Troubleshot employee concerns and recommended corrective actions to resolve issues.
  • Adapted to workflow changes and implemented continuous process improvements to overcome obstacles.
San Ysidro Health Center - Director of Victim Services
National City, CA, 07/2014 - 05/2019

Managed a staff of 14 Sexual Abuse Advocates across a 19 county region. Assisted Executive Director with annual budget. Wrote grant proposals at Federal, State and Local levels. Interviewed, trained new staff. Performed staff Supervision and Reviews. Presented to all age levels - pre-school thru college about Consent per grant guidelines. Presented Sexual Harassment training to Professionals. Presented on CAASA services to various community groups as needed. Undated organizations Employee Handbook and guidelines. Attended State meetings as required.

  • Oversaw staff development through in-depth trainings, workshops, seminars and other learning opportunities.
  • Recruited, interviewed and hired staff members offering exceptional talent and brought great skills to team.
  • Developed and implemented variety of innovative policies and strategies to promote client self-sufficiency.
  • Assisted with researching grants and grant writing tasks.
Siouxland Community Health Center - HIV Medical Case Manager
City, STATE, 08/2009 - 06/2014
  • Collaborated with case managers to assist clients in identifying resources for mental health treatment, substance abuse programs, domestic violence services and housing assistance.
  • Educated clients about living with HIV, preventing further transmission, benefits and challenges of HIV care and treatment and access to resources.
  • Distributed condoms to promote use for HIV-infected persons and persons at highest risk of acquiring HIV.
  • Collected demographic information to accurately complete CDC HIV report forms.
  • Worked with medical teams, patients and families to implement effective treatment plans.
  • Updated treatment plans on monthly basis with latest intervention strategies and progress notes.
  • Provided ongoing counseling to help patients deal with conditions and processes
  • Completed psychosocial evaluations and needs assessments.

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Resume Overview

School Attended

  • Wakefield High School

Job Titles Held:

  • Regulatory Manager
  • Administrator
  • Director of Victim Services
  • HIV Medical Case Manager

Degrees

  • High School Diploma

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