Working in the Research labs, a Regulatory Assistant ensures that every clinical study follows regulations. The job duties commonly listed on the Regulatory Assistant Resume include – keeping up to date with regulations, ensuring that everyone in the lab follows correct procedures, assisting in obtaining and maintaining government approval for drugs, medical devices, and related materials; working on document preparation, information management, file maintenance, and coordination of tasks across multiple departments. Other core duties include maintaining communication between all departments and ensuring a smooth workflow.
Regulatory assistants must be able to work in a demanding environment and be able to adhere to protocols. They have to stay up to date on their area of expertise and possess strong communication, project management, and analytical skills as well. Attention to detail and the ability to adapt quickly to changing regulations are also needed. Every professional in this field is expected to possess at least a bachelor’s degree in subjects such as chemistry, medicine, engineering, biological science, or pharmacy.
Headline : To obtain and secure a Regulatory Assistant position with a company where I can utilize my extensive office management, communication skills, computer knowledge, and interpersonal abilities with an opportunity for advancement and growth.
Skills : Microsoft Office, VBA, Python.
Description :
Prepared invoices, IND safety reports, memos, and letters.
Prepared safety reports and submit them to the regulatory agency IRB.
Transcribed safety reports for submission to the regulatory agency.
Maintained regulatory and sponsor binders for all clinical trials.
Prepared spreadsheet monitoring all adverse effects of study drugs.
Performed all assigned duties using GCP.
Insured timely submission of complete and accurate documents to pharmaceutical companies and the governing regulatory agency.
Experience
5-7 Years
Level
Entry Level
Education
Bachelors Of Applied Science
Regulatory Assistant Resume
Summary : More than eight years of successful experience in a support role, handling time-sensitive, government-mandated regulatory transactions for financial and energy sectors. Ability to coordinate and communicate with multiple internal departments and external agencies to serve as single point of contact for required business processes.
Skills : Autocad, Microsoft Office, Arduino, GPS/GIS, Matlab, ArcMap/ArcGIS.
Description :
Provided administrative and technical support for six regulatory specialists by implementing administrative systems, procedures, and policies, and assisting in the management of daily departmental operations.
Managed monthly regulatory permit transactions which average approximately $100,000.
Collected regulatory data (agreements, permits, and correspondence) from business units and persons knowledgeable.
Researched and verified authorizations for expenditures (AFEs) to process regulatory permit receipts (working closely with business units to confirm receipts are coded correctly).
Coordinated rig moves by initiating requests and communications with internal departments and required government entities.
Ensured rig changes are documented within rig books in accordance with government regulatory agencies such as Coast Guard, BSEE and BOEM.
Utilized e-File system to manage departmental regulatory records.
Experience
7-10 Years
Level
Management
Education
Associate's In Business Administration
Regulatory Assistant Resume
Summary : Strong communicator both in writing and public speaking. Knowledge of current trends, and social networking programs. Self-starter, fast learner, responsible and dedicated team member who always strives for excellence. Personable with instinctive relationship-building qualities. Great problem solving and time management skills with the ability to meet deadlines Proficient with Microsoft Word, Excel, PowerPoint, Access, and Internet Research. Knowledgeable in both PC and MAC programs. Fluent in Spanish.
Skills : Clinical Research, Clinical Trials, Good Clinical Practice, Microsoft Office.
Description :
Assisted Regulatory Associates with the preparation of regulatory documentation including regulatory submissions.
Organized and filed documents in proper portals and software.
In charged of all audit paperwork and submissions.
Collected all necessary documentation and paperwork during audit from internal and external auditor, DEA, FDA and Board of Pharmacy Diligence for client files and all information accompanying such.
In charged of daily C2 submissions and collection of all needed data to ensure proper statistics are kept without a variable of error included.
Received and logged proper client information to be input into C2 systems.
Collected all necessary documentation and paperwork to be included in client files and input into systems to track progression of clients.
Experience
10+ Years
Level
Senior
Education
Diploma
Regulatory Assistant Resume
Summary : Self motivated person looking to find success. I have the needed experience to be successful and I care about my responsibilities.
Skills : MS Office, Communication Skills.
Description :
Tested and documented for company transition to Optiva computer system.
Led training sessions for company employees from multiple departments.
Obtained and reviewed production batch cards for annual review.
Kept master files updated for FDA inspections, creating Material Safety Data Sheets (MSDS) and ingredient lists and following up with chemists for Stability and Compatibility charts.
Communicated with customers on all issues, submit production batch samples for customer approval, release batch to warehouse for filling.
Input formulas into Optiva for pricing and production.
Tracked testing needs for each company and product, submitting samples and organizing test records and inputting information into JD Edwards.
Experience
10+ Years
Level
Senior
Education
MS
Regulatory Assistant Resume
Headline : Seeking a challenging and responsible Regulatory Assistant position with an aggressive firm, where my ability, training, creativity and experience can be most effectively utilized.
Skills : Microsoft Word, Laboratory Skills.
Description :
Acted as communication link between IRB's and regional office.
Coordinated travel arrangements for all staff members.
Updated Doctor's licenses and Curriculum Vitae.
Effectively kept track of Study Projects Annual, 6 Month and Ongoing Reviews.
Prepared, organized and conducted group discussions with Management staff for input on new and upcoming protocols.
Acted as backup receptionist and responded to phone calls and requested from Sponsors, IRB's and Monitors.
Purchased Raw materials, lab equipment, product components and office supplies.
Experience
5-7 Years
Level
Executive
Education
High School Diploma
Regulatory Assistant Resume
Objective : Seeking a Regulatory Assistant poistion with an outstanding career opportunity that will offer a rewarding work environment along with a winning team that will fully utilize management skills.
Skills : Microsoft Word, Developing Skills.
Description :
Completed all necessary paperwork to open Oncology studies and ensure they were running efficiently.
Maintained weekly report for Children's Oncology Group.
Corresponded with a variety of professionals and departments regarding critical issues with Oncology studies.
September 1999 to July 2000 Mental Health Professional, ADAPT - Edwardsville, IL Observed and monitored client behavior and responses to treatment.
Conducted individual and group counseling.
Developed and implemented treatment plans and modified when necessary.
Provided advocacy services to clients by working with nurses and other individuals to ensure they had the best care.
Experience
2-5 Years
Level
Junior
Education
MS
Regulatory Assistant Resume
Summary : Motivated and passionate team-player looking to leverage prior experience to develop additional skills within regulatory compliance and risk management.
Skills : Team Work, Organizational Skills.
Description :
Conducted a variety of research related to regulatory submissions, product requirements and competitive analysis.
Provided team assistance to achieve and maintain product registrations and business objectives in accordance with agreed registration projections.
Monitored and reported product incidents to regulatory agencies.
Coordinated with product managers.
Developed internal tracking system in coordination with key stakeholders for updating and maintaining confidential Statement of Formulas.
Acquired Personal Protective Equipment Training Certification Attended US Environmental Protection Agency, Office of Pesticide Programs organized workshops (e.g. FIFRA, Risk Assessment, Product Label, etc.).
Filled out new vendor applications.
Experience
10+ Years
Level
Senior
Education
Bachelor Of Science
Regulatory Assistant Resume
Headline : To secure a full-time position where I can use the skills that I have learned through college and previous positions to utilize my organizational abilities. I have excellent telephone skills, great organizational skills, and a wide knowledge of computer programs such as Microsoft Excel, Outlook, PowerPoint and Microsoft Word.
Reviewed permit applications for accuracy and completeness for work in Water Sheds of the U.S.
Entered data into the Ombil Regulatory Module (ORM) database software.
Prepared application packets and letters for signature.
Provided customer service to walk-in applicants and telephone inquiries from members of the general public.
Performed database research and file research to correlate historical permit actions against new permit applications.
Performed comprehensive quality audit reviews and reconciliation of essential documents for completeness and verification of data from external sites in preparation for Regulatory Agency inspections.
Led Regulatory Associate performing quality audits of electronic Tile Master Files (eTMF) systems identifying errors and nonconformities according to FDA regulations and internal Quality Control SOPs.
Experience
5-7 Years
Level
Executive
Education
Bachelor Of Science
Regulatory Assistant Resume
Headline : Secure a Regulatory Assistant position that focuses on Project Coordination, Customer Relations, and Team Leadership.
Assisted in the preparation of regulatory IND and NDA submissions to the FDA.
Included compiling, reviewing, and publishing the FDA submissions.
Responsible for IND maintenance of submissions.
Maintained database for all regulatory packages and informed consents.
Reviewed regulatory packages and informed consents for different clinical studies.
Organized, author and disseminate Trial Master File QC trackers documenting findings and potential policy deviations.
Resolved regulatory issues received from various internal and external stakeholders (company rigs, governmental agencies, and consulting groups).
Experience
5-7 Years
Level
Junior
Education
Bachelors Of Science
Regulatory Assistant Resume
Headline : Goal oriented young professional dedicated to high levels of resident and customer satisfaction, and meeting aggressive governmental and corporate goals. -Critical and analytical thinker with specialized knowledge of functions in an office setting. -Both private and public sector experience, which assists in taking a business-like approach towards government agencies, as well as a safe, structured approach towards private opportunities.
Skills : Time Management, Logistics.
Description :
Maintained departmental supplies by monitoring inventory level, placing and expediting orders, and verifying receipt of supplies.
Ensured IRB approval is granted before filing documents in study folder.
Learn, apply and utilize computer software applications to enhance work flow and study activity efficiency.
Assisted with logistical regulatory issues and compile and process required paperwork prior to shipment of customer orders, assist with import/export permit/declaration acquisition and complete reconciliation, assist CPM with US Customs DEA related documentation requests, maintain ARCOS data to reflect sales/purchases, and associated paper records maintenance.
Created new customer files and update on an on-going basis CS customer files allowing readily retrievable records for each customer.
Maintained Dosage Form Market data updates, assist with order review to flag suspicious orders and prepare and maintain documentation of any related investigations.
Processed renewal applications to maintain various State License requirements.
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