Vice President Regulatory Affairs

Vice President Regulatory Affairs Resume Keywords and Skills (Hard Skills)

Here are the keywords and skills that appear most frequently on recent Vice President Regulatory Affairs 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 Submissions
  • U.S. Food and Drug Administration (FDA)
  • Clinical Development
  • Biotechnology
  • Life Sciences
  • Biopharmaceuticals
  •  Find out what your resume's missing
  • Clinical Trials
  • Drug Development
  • Regulatory Requirements
  • Good Manufacturing Practice (GMP)
  • Standard Operating Procedure (SOP)
  • Good Clinical Practice (GCP)
  • CRO Management
  • Corrective and Preventive Action (CAPA)
  • Validation
  • Regulations
  • Oncology
  • Pharmacovigilance
  • Commercialization

  •   Show full list

Resume Skills: Software

Resume Skills: Regulatory Compliance

Resume Skills: Project Management

  • Risk Management
  • Scrum
  • Agile
  • Gantt charts
  • MS Project
  • Resource Management
  • Regulatory Roadmap Development
  • Risk Assessment
  • Resource Allocation
  • Cross-functional Team Leadership
  • Quality Assurance
  •  Match your resume to these skills

Resume Skills: Languages

Resume Skills: Regulatory Affair Tools

Resume Skills: Regulatory Guidelines

Resume Skills: Business

Resume Skills: Regulatory Expertise

  • FDA/EMA Regulation
  • Asia-Pacific Drug Regulations
  • Medical Device Regulation
  • Regulatory Submissions
  • Clinical Trial Authorization
  • Drug Legislation
  •  Match your resume to these skills
  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 Vice President Regulatory Affairs 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 Vice President Regulatory Affairs 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
Vice President Regulatory Affairs
City, Country  •  (123) 456-789  •  [email protected]  •
Resume Worded January 2019 - Present
Vice President Regulatory Affairs
Implemented a robust Corrective and Preventive Action (CAPA) system, reducing regulatory compliance breaches by 35%.
Strategized and led clinical development programs for three new drugs, accelerating the product pipeline and securing FDA approval 10 months ahead of schedule.
Initiated Regulatory Affairs training programs for internal teams, improving understanding of regulatory requirements and increasing team efficiency by 20%.
Spearheaded the submission of two successful biopharmaceuticals applications, resulting in a revenue growth of $20M in the first year.
Developed a streamlined Standard Operating Procedure (SOP) for regulatory submissions, reducing process bottlenecks and improving turnaround time by 30%. February 2013 - December 2018
Director of Regulatory Affairs
Directed the process of creating and maintaining global product registrations, increasing our market reach by 15%.
Served as the lead liaison for Good Manufacturing Practice (GMP) audits, achieving an overall decrease in critical discrepancies by 40%.
Leveraged extensive knowledge on regulatory negotiations with the FDA, optimizing the achievement of product approvals within the stipulated time frames.
Johnson & Johnson June 2007 - January 2013
Senior Regulatory Affairs Specialist
Drafted and submitted 5 successful Investigational New Drug (IND) applications, facilitating the progress of vital clinical trials.
Increased departmental efficiency by 10% by effectively leading a cross-functional project team in ensuring Good Clinical Practice (GCP).
Supported the pharmacovigilance department with post-marketing safety updates, reducing the incidence of adverse events by 15%.
Resume Worded University June 2010
Master of Business Administration - Pharmaceutical Management
Focus: Strategic and Regulatory Affairs in Pharmaceutical Industry
Resume Worded Academic Center May 2007
Bachelor of Science - Biotechnology
Leadership Role: Organized annual biotech symposia
Honors: Graduated Summa cum Laude
Regulatory Affair Tools: eCTD software, SAS, Parexel Liquent InSight, Adobe Acrobat Professional, ArborText Editor.
Regulatory Guidelines: ICH, IND, NDA, ANDA, sNDA, BLA, GCP, GLP, GMP, HIPAA, FDA, EMEA, MHRA.
Business Skills: Strategic Planning, Risk Management, Healthcare Consulting, Business Operations, Project Management (PMP).
Languages: English (native), Spanish (intermediate), French (basic).
Certifications: Regulatory Affairs Certification (RAC), Certified Regulatory Compliance Manager (CRCM).
Leadership & Volunteering: Board Member - American Society for Quality (ASQ), Volunteer RSSO - American Cancer Society.
Awards: Nobel Laureate Meeting Participant 2017, Regulatory Affairs Professional Society - Special Recognition Award.
Publications: Co-authored three industry relevant papers in 'Drug Development and Industrial Pharmacy Journal'.
Your Name
VP of Regulatory
City, Country  •  (123) 456-789  •  [email protected]  •
Genentech July 2017 - Present
VP of Regulatory
Managed a multi-disciplinary team across multiple biotech projects, resulting in two Investigational New Drug (IND) approvals in 24 months.
Fostered strong relationships with international regulatory agencies, significantly reducing process-related delays.
Revitalized the company’s clinical trial documentation process, leading to a 25% increase in the speed of regulatory filings.
In cooperation with commercialization team, prepared and secured marketing authorization for two new biopharmaceutical products in record time.
Implemented advanced technology to improve management of regulatory information, delivering a 30% reduction in administrative time. May 2010 - June 2017
Regulatory Affairs Manager
Led oncology-focused clinical trials, resulting in the successful commercialization of a vital cancer drug.
Spearheaded a team of 7 in creating a comprehensive strategic approach for dealing with FDA and other health authorities.
Maintained strict adherence to national and international legislation, guidelines and customer practices across all projects.
Resume Worded January 2003 - April 2010
Senior Regulatory Specialist
Enhanced adherence to Good Clinical Practice (GCP) and Corrective and Preventive Action (CAPA), ensuring 100% compliance in audits.
Streamlined the Regulatory Affairs processes, boosting document submission speed by 20%.
Resume Worded Institute June 2019
Certificate in Biotechnology Regulatory Affairs
Coursework included topics on global regulatory strategy, pharmaceutical law, clinical trials regulations
Resume Worded University May 2003
Master of Business Administration (MBA) - Regulatory Affairs Concentration
Thesis: The Ethics and Regulation of Genetic Engineering
Regulatory Expertise: FDA/EMA Regulation, Asia-Pacific Drug Regulations, Medical Device Regulation, Regulatory Submissions, Clinical Trial Authorization, Drug Legislation
Software: MS Office Suite, TrackWise, MasterControl, Regulatory Information Management Systems, Document Management Systems
Project Management: Regulatory Roadmap Development, Risk Assessment, Resource Allocation, Cross-functional Team Leadership, Quality Assurance
Languages: English (Native), Spanish (Fluent), German (Conversational)
Certifications: Regulatory Affairs Certification (RAC) (2011), Project Management Professional (PMP) (2008)
Awards: Genentech Excellence in Leadership Award (2020), Outstanding Achievement in Management (2015)
Volunteering: Mentor with MedTech Innovators - Providing guidance to novice leaders in the medical technology industry
Publications: Authored ‘21st Century Regulatory Environment: Challenges and Solutions’ - An in-depth research paper dissecting the evolving regulatory landscape in the Pharma industry
Your Name
Group Vice President
City, Country  •  (123) 456-789  •  [email protected]  •
Novartis February 2015 - Present
Group Vice President - Regulatory
Drove process improvement initiatives that reduced costs associated with submission inefficiencies by 25%.
Overhauled Regulatory Affairs department to develop a risk-based Corrective and Preventive Action (CAPA) program, mitigating potential compliance issues.
Spearheaded an effort to align the company with the FDA's evolving regulations, ensuring prompt product time-to-market.
Promoted an atmosphere of cross-functional cooperation facilitating quicker response to regulatory changes.
Directed the seamless process of securing FDA approval for five biopharmaceutical drugs, leading to a revenue increase of $40M.
Resume Worded July 2007 - January 2015
Senior Director - Regulatory Affairs
Established favorable relations with global health authorities, leading to expedited approvals and increased market presence.
Drastically improved team's understanding of the drug development process resulting in quicker turnaround times.
Played a key role in inspection readiness and reducing the number of audit findings by 30%. December 2000 - June 2007
Regulatory Affairs Lead
Delivered accurate regulatory intelligence, enabling the company to adjust strategies.
Oversaw the smooth execution of two successful biotechnology clinical trials.
Resume Worded University December 2006
Master of Business Administration
Specialization in Regulatory Affairs and Compliance Management
Resume Worded Institute December 2000
Bachelor of Science - Biochemistry
Ranked within top 10% of class
Recipient of Regulatory Affairs Internship
Regulatory Compliance: ISO 13485, FDA regulations, European CE Marking, Regulatory submissions, QSR, ICH guidelines
Project Management: Risk Management, Scrum, Agile, Gantt charts, MS Project, Resource Management
Software Proficiency: SAP, MS Office Suite, Jira, Confluence, Sharepoint
Languages: English (Native), French (Conversational), German (Basic)
Certifications: Certified Regulatory Affairs Professional (RAPS), Six Sigma Green Belt
Leadership & Volunteering: Chairperson of the Resume Worded Professional Network 2015-present, Voluntary Regulatory Consultant at Non-profit Organisations 2010-present
Publications: Authored 3 papers published in the Journal of Regulatory Affairs, Regular contributor to Regulatory Intelligence newsletter
Conferences: Speaker at international Regulatory Affairs Summits, Attendee of annual FDA workshops

How do I add skills to a Vice President Regulatory Affairs resume?

Review the job posting closely.

Go through the Vice President Regulatory Affairs posting you're applying to, and identify hard skills the company is looking for. For example, skills like Biotechnology, Regulatory Submissions and Life Sciences are possible skills. These are skills you should try to include on your resume.

Add industry skills like Clinical Trials and Biopharmaceuticals.

Add other common skills from your industry - such as Clinical Development, Regulatory Affairs and U.S. Food and Drug Administration (FDA) - into your resume if they're relevant.

Add skills into your work experience.

Incorporate skills - like Drug Development, Validation and Good Manufacturing Practice (GMP) - into your work experience too. This shows hiring managers that you have practical experience with these tools, techniques and skills.

Use the exact job title.

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

Word Cloud for Vice President Regulatory Affairs Skills & Keywords

The following word cloud highlights the most popular keywords that appear on Vice President Regulatory Affairs 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 Vice President Regulatory Affairs Skills and Keywords to Include On Your Resume

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Vice President Regulatory Affairs 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
Regulatory Affairs Specialist

Resume Example
Regulatory Affairs Manager

Resume Example
Regulatory Affairs Associate (Entry Level)

Resume Example

Resume Example
Highlights (Free)

Resume Example
Modern Two-Column

Browse Skills from Similar Jobs

Frequently Asked Questions

What hard skills should you include on a Vice President Regulatory Affairs resume?

Here are some of the most popular skills we see on Vice President Regulatory Affairs resumes:

  • Regulatory Affairs
  • Regulatory Submissions
  • U.S. Food and Drug Administration (FDA)
  • Clinical Development
  • Biotechnology
  • Life Sciences
  • Biopharmaceuticals
  • Clinical Trials

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

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