Regulatory Specialist

Regulatory Specialist Resume Keywords and Skills (Hard Skills)

Here are the keywords and skills that appear most frequently on recent Regulatory Specialist job postings. In other words, these are the most sought after skills by recruiters and hiring managers. Go to Sample Templates ↓ below to see how to include them on your resume.

Remember that every job is different. Instead of including all keywords on your resume, identify those that are most relevant to the job you're applying to. Use the free Targeted Resume tool to help with this.

Choose a category
  • Regulatory Affairs
  • Regulatory Compliance
  • Regulatory Submissions
  • U.S. Food and Drug Administration (FDA)
  • Regulatory Requirements
  • Clinical Trials
  • Standard Operating Procedure (SOP)
  •  Find out what your resume's missing
  • Good Clinical Practice (GCP)
  • Regulatory Documentation
  • Clinical Research
  • Electronic Common Technical Document (eCTD)
  • Good Manufacturing Practice (GMP)
  • Biotechnology
  • Regulations
  • Life Sciences
  • Clinical Development
  • Validation
  • Drug Development
  • Environmental Compliance
  • Quality System

  •   Show full list

Resume Skills: Industry Knowledge

  • FDA Regulations
  • EU Regulations
  • Medical Devices
  • Pharmaceuticals
  • Biologicals
  • AML
  • KYC
  • SOX
  • GDPR
  • CCPA
  • ISO 9001
  • Biotechnology
  • Healthcare
  • Clinical Data Management
  •  Match your resume to these skills

Resume Skills: Regulatory Tools

Resume Skills: Techniques

Resume Skills: Languages

Resume Skills: Regulatory Compliance

Resume Skills: Technical

Resume Skills: Compliance Software

Resume Skills: Data Analysis

Resume Skills: Compliance

  Does your resume contain all the right skills? Paste in your resume in the AI Resume Scan ↓ section below and get an instant score.

Compare Your Resume To These Regulatory Specialist Skills (ATS Scan)

Paste your resume below and our AI will identify which keywords are missing from your resume from the list above (and what you need to include). Including the right keywords will help you get past Applicant Tracking Systems (i.e. resume screeners) which may scan your resume for keywords to see if you're a match for the job.

Sample Regulatory Specialist Resume Examples: How To Include These Skills

Add keywords directly into your resume's work experiences, education or Skills section, like we've shown in the examples below. Use the examples below as inspiration.

Choose a template
Your Name
Regulatory Specialist
City, Country  •  (123) 456-789  •  [email protected]  •  linkedin.com/in/your-profile
EXPERIENCE
Resume Worded June 2020 - Present
Senior Regulatory Specialist
Streamlined the process of regulatory submissions, cutting turnaround time by 40%.
Devised and enforced regulatory requirements, ensuring 100% compliance with FDA norms.
Implemented eCTD for regulatory documentation, significantly reducing paper usage and boosting transparency.
Spearheaded a cross-functional team for information management in line with Good Clinical Practice.
Conducted regular regulatory affairs training, boosting the team's proficiency by 45%.
Pfizer January 2017 - May 2020
Regulatory Compliance Officer
Managed and monitored drug development processes to ensure adherence to regulatory rules.
Created Standard Operating Procedures (SOPs) for project teams, increasing efficiency by 35%.
Analyzed clinical trials data, optimizing execution strategies and improving outcomes by 20%.
Coached.com September 2013 - December 2016
Regulatory Affairs Associate
Administered submission of regulatory documents in accordance with Good Manufacturing Practice (GMP).
Supported oversight of environmental compliance, reducing the company's carbon footprint by 20%.
Participated in life sciences projects, ensuring regulatory accordance and boosting overall project success by 15%.
EDUCATION
Resume Worded Institute 2012
Master of Sciences in Regulatory Affairs
Concentration in Healthcare and Pharmaceutical Regulation
Resume Worded University 2010
Bachelor of Sciences - Biology
Minor in Chemistry
Honors: Biochemistry Research Fellowship, Dean's List
SKILLS
Regulatory Compliance: GLP, GCP, GMP, HIPAA, FDA regulations, MDR, ICH guidelines, Clinical Trials Administration.
Technical Skills: Microsoft Office Suite, Adobe Acrobat, URSULA, Oracle, Basecamp, Visio
Industry Knowledge: Pharmaceuticals, Biotechnology, Healthcare, Clinical Data Management, Medical Devices
Languages: English (Native), Spanish (Fluent), German (Conversational)
OTHER
Certifications: Certified in Regulatory Affairs – Pharmaceuticals (RAPS) (2017), Advanced Certificate in Clinical Trial Administration (2013)
Leadership & Volunteering: Active member, Regulatory Affairs Professional Society (RAPS), Volunteer, Local Healthcare Center
Professional Development: Attended International Conference on Harmonization (ICH), Clinical Trial Regulation Workshops, and FDA Compliance Symposium.
Your Name
Compliance Specialist
City, Country  •  (123) 456-789  •  [email protected]  •  linkedin.com/in/your-profile
EXPERIENCE
Coached.com April 2019 - Present
Senior Compliance Specialist
Overhauled the electronic compliance tracking system, improving data accuracy by 27%.
Championed a compliance-driven culture, reducing non-compliance incidence by 50%.
Mentored and developed junior compliance specialists, increasing team productivity by 30%.
Spearheaded implementation of Good Manufacturing Practice (GMP) standards, achieving 100% compliance.
Led quarterly internal audits, identifying gaps and reducing discrepancies by 70%.
McKesson Corporation October 2015 - March 2019
Compliance Officer
Coordinated with regulatory bodies such as the FDA to ensure adherence to regulations.
Promoted awareness of Good Clinical Practice (GCP) amongst clinical team, improving adherence by 46%.
Managed regulatory reporting, ensuring timely submission and reducing penalties by 60%.
Resume Worded August 2012 - September 2015
Compliance Analyst
Conducted thorough validation of regulatory documentation, reducing discrepancies by 22%.
Contributed to the improvement of Standard Operating Procedures (SOPs), enhancing process efficiency by 38%.
Reviewed clinical research operations, ensuring alignment with legal and regulatory standards.
EDUCATION
Resume Worded Institute August 2018
Certified Regulatory Compliance Manager (CRCM)
Participated in 10+ hours of compliance training per week
Resume Worded University June 2012
Master of Laws (LLM) - Business and Finance
Specialized in Data Protection and Privacy Law
SKILLS
Compliance Software: ACL, SURPASS, Expert System, CUBE, Compliance 360, Q-Pulse
Data Analysis: Excel (Advanced), SQL, Python, R, Tableau, PowerBI
Regulatory Knowledge: AML, KYC, SOX, GDPR, CCPA, ISO 9001
Languages: English (Native), Spanish (Conversational), German (Basic)
OTHER
Certifications: Association of Certified Anti-Money Laundering Specialists (ACAMS) - Certified Anti-Money Laundering Specialist (2020)
Leadership & Volunteering: Worked with Rotary International on compliance and ethics development in local schools (2016-present)
Conferences & Seminars: Regular attendee at National Regulatory Services compliance conferences, Association of Corporate Counsel annual meetings
Your Name
Regulatory Affairs Manager
City, Country  •  (123) 456-789  •  [email protected]  •  linkedin.com/in/your-profile
EXPERIENCE
Resumed Worded March 2021 - Present
Senior Regulatory Affairs Manager
Implemented a new strategy for regulatory submissions, achieving a 99% acceptance rate.
Oversaw the development and implementation of internal audit processes, ensuring optimum regulatory compliance.
Coordinated the use of eCTD for regulatory documentation, increasing efficiency by 35%.
Developed and delivered FDA compliance training to 100+ team members, standardizing operational practices.
Led regulatory affairs team in compliance with clinical development procedures, achieving 100% adherence.
Johnson & Johnson January 2017 - February 2021
Regulatory Affairs Team Lead
Spearheaded the process of regulatory documentation according to Good Clinical Practices.
Managed biotechnology project compliance, ensuring alignment with established regulations.
Boosted team efficacy in handling regulatory requirements, contributing to company's reputation in the drug development market.
Coached.com July 2014 - December 2016
Regulatory Affairs Associate
Worked on standardizing the regulatory documentation process in compliance with FDA norms.
Contributed to refining clinical research protocols, aligning practices with SOPs.
Supported development of an efficient, Quality System-compliant regulatory affairs process.
EDUCATION
Resume Worded Academic Center February 2017
Master of Science - Regulatory Affairs & Quality Assurance
Specialized in Pharmaceutical Sciences
Resume Worded University July 2014
Bachelor of Science - Biology
Minors in Chemistry and Business Management
Awards: Dean's List 2013 (Top 10%)
SKILLS
Regulatory Tools: DrugAbacus, Knowledge Management System (KMS), Quality Management System (QMS), GMP/GDP
Compliance: FDA Guidelines, ICH Regulations, Medical Device Regulations, Clinical Trials Oversight, ISO 13485
Technical: Microsoft Office Suite, SAP, TrackWise, SharePoint
Languages: English (Native), Spanish (Fluent), French (Conversational)
OTHER
Certifications: Certified Professional in Regulatory Affairs (RAPS, 2019)
Leadership & Volunteering: Resume Worded Foundation (Board Member and Chair), American Society for Quality (Member)
Professional Development: Attended Regulatory Affairs Professionals Society (RAPS) Convergence 2020
Publications: Co-authored 'The New Age of Pharmaceutical Regulations' in The Regulatory Review

How do I add skills to a Regulatory Specialist resume?

1
Review the job posting closely.

Go through the Regulatory Specialist posting you're applying to, and identify hard skills the company is looking for. For example, skills like Regulatory Submissions, Regulatory Compliance and Good Clinical Practice (GCP) are possible skills. These are skills you should try to include on your resume.

2
Add industry skills like Regulatory Requirements and U.S. Food and Drug Administration (FDA).

Add other common skills from your industry - such as Clinical Trials, Regulatory Affairs and Standard Operating Procedure (SOP) - into your resume if they're relevant.

3
Add skills into your work experience.

Incorporate skills - like Electronic Common Technical Document (eCTD), Environmental Compliance and Clinical Development - into your work experience too. This shows hiring managers that you have practical experience with these tools, techniques and skills.

4
Show how you have strong attention to detail.

A good Regulatory Specialist has strong attention to detail, so try to include examples of where you handled complex projects or processes.

5
Use the exact job title.

Try to add the exact job title, Regulatory Specialist, somewhere into your resume to get past resume screeners. See the infographic for how to do this.

Word Cloud for Regulatory Specialist Skills & Keywords

The following word cloud highlights the most popular keywords that appear on Regulatory Specialist job descriptions. The bigger the word, the more frequently it shows up on employer's job postings. If you have experience with these keywords, include them on your resume.

Top Regulatory Specialist Skills and Keywords to Include On Your Resume

Get your Resume Instantly Checked, For Free

Upload your resume and we'll spot the issues in it before an actual Regulatory Specialist recruiter sees it. For free.

Regulatory Specialist Resume Templates

Here are examples of proven resumes in related jobs and industries, approved by experienced hiring managers. Use them as inspiration when you're writing your own resume. You can even download and edit the resume template in Google Docs.

Resume Example
Professional


Resume Example
Highlights (Free)


Resume Example
Modern Two-Column


Resume Example
Clean Modern


Resume Example
Entry-Level (Free)


Resume Example
Concise


Browse Skills from Similar Jobs

Frequently Asked Questions

What skills should you add to a Regulatory Specialist resume?

Some effective Regulatory Specialist skills you can add to your resume include:

  • Regulatory Affairs
  • Regulatory Compliance
  • Regulatory Submissions
  • U.S. Food and Drug Administration (FDA)
  • Regulatory Requirements
  • Clinical Trials
  • Standard Operating Procedure (SOP)
  • Good Clinical Practice (GCP)

Target your Resume to a Job Description

While the keywords above are a good indication of what skills you need on your resume, you should try to find additional keywords that are specific to the job. To do this, use the free Targeted Resume tool. It analyzes the job you are applying to and finds the most important keywords you need on your resume.

It is personalized to your resume, and is the best way to ensure your resume will pass the automated resume filters.

Start targeting your resume

© 2024 Resume Worded. All rights reserved.

Get expert insights from hiring managers
×