Regulatory Specialist

Writing a great regulatory specialist resume is important because it is one of the first things a potential employer will see when they are considering you for a position. It is your opportunity to make a good first impression and sell yourself as the best candidate for the job.

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If you're looking for inspiration when it comes to drafting your own regulatory specialist resume, look no further than the samples below. These resumes will help you highlight your experience and qualifications in the most effective way possible, giving you the best chance of landing the regulatory specialist job you're after.

Resume samples

Aviona Turnipseed

aviona.turnipseed@gmail.com | (696) 153-6642 | 4900 US-93, Whitefish, MT 59937, USA

Summary


I am a Regulatory Specialist with over 4 years experience in the medical device industry. I have worked on projects ranging from new product development to post-market surveillance, and have gained an in-depth understanding of the regulatory landscape. I am well versed in both US and EU regulations, and have a proven track record of ensuring compliance with all relevant requirements. My strong analytical skills allow me to quickly identify potential issues and develop creative solutions that meet all regulatory requirements while minimizing business impact.

Experience


Regulatory Specialist at Optimal Solutions & Technologies, MTMar 2022 - Present

  • Negotiated and created new regulations with local, state, and federal agencies which resulted in a decrease of production costs by 15%.
  • Wrote over 50 pages of documentation for new safety procedures that were put into place, resulting in 0 accidents or injuries in the past 3 years.
  • Successfully lobbied to have 5 different bills passed that reformed environmental regulation policies.
  • Worked with team to develope an online permitting system saving the company $100,000 per year.
  • Conducted analysis on potential impacts of proposed regulations changes on business processes.

Regulatory Affairs Specialist at Deloitte, MTSep 2018 - Jan 2022

  • Reviewed and approved documents for regulatory compliance.
  • Ensured that all products were in compliance with regulations.
  • Monitored changes in regulations and updated policies accordingly.
  • Trained new employees on regulatory requirements.
  • Led initiatives to improve the efficiency of the regulatory department.
  • Authored standard operating procedures for the department.

Education


Bachelor of Science in Regulatory Affairs at Montana State UniversitySep 2014 - May 2018

Through my degree I have learned how to read and interpret scientific and technical information, how to write reports and proposals, and how to communicate effectively with scientists and regulatory authorities.

Skills


  • Regulatory Affairs
  • Clinical Trials
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • 21 CFR Part 11 Compliance
  • Validation

Germaine Eldrige

germaine.eldrige@gmail.com | (148) 757-6766 | Omaha, NE

Summary


I have over 4 years of experience as a Regulatory Specialist. I am responsible for ensuring compliance with regulatory requirements and providing support to the organization's management team. I have developed strong analytical and problem solving skills, which has allowed me to effectively identify and resolve compliance issues. Additionally, I have excellent communication skills that allow me to keep Management informed of changes in regulations that may impact the organization.

Experience


Regulatory Specialist at Sandhills Publishing, NEJun 2022 - Present

  • Reduced the amount of time spent on regulatory compliance by 15%.
  • Streamlined the process for submitting reports to regulators, resulting in a 10% reduction in paperwork.
  • Negotiated with regulators to allow for more flexibility in meeting deadlines, saving the company $5,000 in penalties.
  • Trained 3 new employees on regulatory procedures and policies.
  • Reviewed and updated 5 company policies to ensure compliance with changing regulations.

Regulatory Affairs Specialist at Nelnet, NESep 2018 - May 2022

  • Negotiated and secured approval for 5 new clinical trial applications with the FDA in record time.
  • Wrote and implemented 10 successful SOPs for regulatory compliance.
  • Trained 15 new employees on ICH GCP guidelines.
  • Successfully managed 20 Investigational New Drug (IND) submissions per year.
  • Led 3 teams of 4-5 people in completing tasks related to regulatory affairs.

Education


Bachelor of Science in Regulatory Affairs at University of Nebraska-LincolnSep 2014 - May 2018

Some skills I've learned are: critical thinking, problem solving, writing, and multitasking.

Skills


  • Regulatory Affairs
  • Clinical Trials
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • Regulatory Writing
  • Electronic Submissions