Regulatory Affairs Manager

Regulatory Affairs Manager Resume Keywords and Skills (Hard Skills)

Here are the keywords and skills that appear most frequently on recent Regulatory Affairs Manager 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)
  • Regulatory Requirements
  • Good Manufacturing Practice (GMP)
  • Standard Operating Procedure (SOP)
  • Validation
  •  Find out what your resume's missing
  • Quality System
  • Biotechnology
  • Corrective and Preventive Action (CAPA)
  • ISO 13485
  • Clinical Trials
  • Electronic Common Technical Document (eCTD)
  • Life Sciences
  • Regulatory Compliance
  • Change Control
  • Design Control
  • Medical Devices
  • Cross-functional Team Leadership
  • Drug Development

  •   Show full list

Resume Skills: Software

Resume Skills: Regulatory Affair Software

Resume Skills: Regulatory Standards

Resume Skills: Other Technical

Resume Skills: Languages

Resume Skills: Document Management Systems

Resume Skills: Regulatory Frameworks

Resume Skills: Regulations

Resume Skills: Techniques

Resume Skills: Regulatory Tools

Resume Skills: Compliance

Resume Skills: Technical

  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 Affairs Manager 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 Affairs Manager 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.

Select a free resume example
Your Name
Regulatory Affairs Manager
City, Country  •  (123) 456-789  •  [email protected]  •  linkedin.com/in/your-profile
EXPERIENCE
Resume Worded January 2021 - Present
Regulatory Affairs Manager
Guided submission of 15+ electronic Common Technical Document (eCTD) formats, resulting in an 80% approval rate from the FDA
Implemented Standard Operating Procedure (SOP) and Good Manufacturing Practice (GMP), escalating quality control by 60%
Collaborated with cross-functional teams to conduct clinical trials navigating through regulatory compliance achieving 90% success.
Johnson & Johnson January 2018 - December 2020
Senior Regulatory Affairs Specialist
Revamped validation process that improved efficiency by 45%
Executed Corrective and Preventive Action (CAPA), reducing manufacturing issues by 40%
Facilitated design control strategy for new medical devices, speeding up product development by 35%.
EDUCATION
Resume Worded Institute December 2017
Master of Science in Regulatory Affairs
Specialization in Medical Devices Regulations
Resume Worded University May 2013
Bachelor of Science in Biological Sciences
Minors in Chemistry and Health Care Policy
Dean's List 2012 (Top 10%)
SKILLS
Regulations: FDA Regulations, EU Regulations, APAC Regulations, ISO Certified, GMP, ICH Guidelines
Software: Microsoft Office, SharePoint, Adobe Acrobat, TrackWise, MS Project, MS Access
Techniques: Risk Management, Project Management, Quality Assurance, Submission Production, Vendor Management, Regulatory Strategy Development
Languages: English (Native), Spanish (Conversational)
OTHER
Certifications: Certified Regulatory Affairs Professional (RAC), Certified Quality Auditor (CQA)
Awards: Quality Excellence Award (2019), Top Performer Award (2018)
Volunteering: MedShare (Volunteer Coordinator)
Projects: Established the 'Regulatory Ready' community for young professionals
Your Name
Regulatory Affairs Specialist
City, Country  •  (123) 456-789  •  [email protected]  •  linkedin.com/in/your-profile
EXPERIENCE
Coached.com March 2022 - Present
Regulatory Affairs Specialist
Navigated product development in alignment with ISO 13485, improving product quality by 50%
Enhanced biotechnology procedures, leading to a 70% increase in laboratory productivity
Managed regulatory submissions in accordance with FDA requirements leading to a 50% increase in approval rate.
Pfizer June 2017 - February 2022
Regulatory Affairs Associate
Implemented a robust regulatory strategy resulting in a 40% increase in drug approval rates
Boosted compliance with regulatory requirements, enhancing audit success by 70%
Applied a proactive change control system, decreasing procedural delays by 60%.
EDUCATION
Resume Worded Institute June 2018
CAPRA (Certificate for Achievement in Regulatory Affairs) - Diploma
Part-time course concurrently managed with role at Pfizer
Resume Worded University May 2017
Bachelor of Science - Biochemistry
Relevant Coursework: Molecular Biology, Organic Chemistry, Research Ethics
SKILLS
Regulatory Affair Software: Regulatory One, MasterControl, Veeva Vault RIM, ennov Regulatory, LORENZ DocuBridge
Regulatory Standards: ICH Guidelines, FDA Regulations, CE Marking, ISO 13485, MDR and IVDR
Other Technical Skills: Quality Assurance, GxP (GMP/GCP/GLP), SOP Development, Clinical Trials, Risk Assessment (ISO 14971)
Languages: English (Native), Spanish (Professional Proficiency), German (Conversational)
OTHER
Certificate Courses: Advanced Certificate Course in Intellectual Property Rights (IPR) - 2019, Basic Course in Drug and Device Law - 2020
Awards & Recognition: Pfizer Pinnacle Excellence Award in Regulatory Affairs - 2019, Coached.com’s Exceptional Performer Award - 2023
Presentations & Publications: Presented a case study on 'Impact of MDR and IVDR on medical devices’ at RAPS 2020 Conference, Published an article titled 'Understanding ICH guidelines for effective regulatory affairs' in Journal of Regulatory Affairs - 2021
Your Name
Senior Regulatory Affairs Associate
City, Country  •  (123) 456-789  •  [email protected]  •  linkedin.com/in/your-profile
EXPERIENCE
Resume Worded June 2021 - Present
Senior Regulatory Affairs Associate
Oversaw 20+ international regulatory submissions leading to a 85% approval rate
Streamlined the quality system in compliance with GMP, boosting operational efficiency by 50%
Implemented methodology for managing CAPA, reducing by 40% the product non-compliance issues.
Merck & Co. January 2017 - May 2021
Regulatory Affairs Analyst
Accelerated drug development by coordinating robust design control strategies
Utilized eCTD guidelines for regulatory submission, resulting in a 75% approval rate
Increased the quality of life sciences projects by embedding FDA regulations into standard operating procedures.
EDUCATION
Resume Worded University May 2016
Master of Health Administration
Focus: Health Policy and Law
Resume Worded Academic Center April 2012
Bachelor of Science - Biochemistry
Honors: Cum Laude, Dean's List 2010-2012
SKILLS
Document Management Systems: MasterControl, Veeva Vault, Documentum, Q-Pulse, isoTracker
Regulatory Frameworks: FDA, EMA, MHRA, PMDA, ICH
Software & Tools: Microsoft Office Suite (Advanced), Adobe Acrobat (Advanced), SAP (Profound)
Languages: English (Native), Spanish (Intermediate), French (Basic)
OTHER
Certifications: Regulatory Affairs Certification (RAC) - US (2020), RAPS Certified
Publications: Published article on Regulatory Harmonization in 'The Regulatory Rapporteur Journal' (May, 2019)
Volunteering: Mentor, Biochemical Society’s Mentoring Scheme (2018- present)
Projects: Coordinated submission and approval of 3 IND applications resulting in successful market approval of leading drugs (2018-2019)
Your Name
Director Of Regulatory Affairs
City, Country  •  (123) 456-789  •  [email protected]  •  linkedin.com/in/your-profile
EXPERIENCE
Resume Worded June 2018 - Present
Director Of Regulatory Affairs
Standardized and streamlined electronic common technical document (eCTD) processes, yielding a 30% increase in efficiency and expedited first-time regulatory submissions
Devised an efficient compliance-based approach for managing regulatory requirements that reduced regulatory risks by 20%
Led a team of 15 to prepare and submit high-quality U.S. FDA IND applications, resulting in a 100% approval rate
Orchestrated remediation of Corrective and Preventive Action (CAPA), securing Standard Operating Procedure (SOP) enhancements
Nurtured effective relationship with FDA and key global health authorities, achieving regulatory compliance.
Coached.com February 2014 - May 2018
Senior Regulatory Affairs Manager
Signed off on significant Good Manufacturing Practice (GMP) submissions, including multiple successful NDA and MAA applications
Oversaw the Clinical Development for a portfolio of projects in Oncology, leading to the entry of two new cancer drugs into the market
Implemented U.S. Title 21 CFR Part 11 Regulation to guarantee data integrity and protection.
Johnson & Johnson July 2007 - January 2014
Regulatory Affairs Specialist
Spearheaded lifecycle management for a portfolio of biopharmaceutical products, resulting in a 10% increase in market share
Contributed in the development of validation protocols to ensure excellent manufacturing practices.
Merck April 2005 - June 2007
Quality Assurance Associate
Assisted in CAPA investigations leading to the reduction of defect rates by 15%
EDUCATION
Resume Worded University June 2013
Master's in Public Health and Policy
Specialization in Biostatistics and Epidemiology, Graduated Summa Cum Laude (Top 1%)
Resume Worded Institute June 2007
Bachelor of Science in Biochemistry
Minor in Health Finance and Management
Sigma Xi Scientific Research Honor Society
SKILLS
Regulatory Knowledge: FDA regulation, EU MDR regulation, Regulatory Compliance, Pharmacovigilance, ISO 13485, Risk Management, MDD to MDR transition
Technical Skills: Microsoft Office Suite, SAP, Regulatory Information Management System(RIMS), Document Management Systems(DMS), eCTD Submissions, GCP, GMP, GLP
Project Management: Agile Methodologies, Scrum, Lean Six Sigma (Green Belt), Project Coordination, Stakeholder Management, Time Management, Cross-functional Team Leadership
Languages: English (Native), Spanish (Intermediate), German (Basic)
OTHER
Certifications: Regulatory Affairs Certification (RAC) – US, Certified Manager of Quality/Organizational Excellence (ASQ CMQ/OE)
Leadership & Volunteering: Board Member, Regulatory Affairs Professionals Society (RAPS), Volunteer Health Policy Advocate, American Lung Association
Professional Development: Attended numerous regulatory affairs and health policy seminars and workshops
Publications: Co-authored research paper on 'The Impact of Regulatory Policies on Public Health' published in The Health Affairs Journal
Your Name
Senior Regulatory Affairs Manager
City, Country  •  (123) 456-789  •  [email protected]  •  linkedin.com/in/your-profile
EXPERIENCE
Resume Worded May 2016 - Present
Senior Regulatory Affairs Manager
Managed the execution of successful biologics license applications (BLA) with the US FDA, leading to quicker regulatory approvals
Handled regulatory affairs for the Clinical Trials phase, ensuring compliance with Good Clinical Practice (GCP) policies and achieving a 20% boost in clinical trial efficiency
Implemented a peer review process for regulatory submissions, leading to a 15% reduction in revision requirements
Led the company's interactions with European Medicines Agency (EMA), streamlining procedures and fostering a constructive relationship
Orchestrated the development and implementation of CMC strategies that reduced development time by 10%.
Coached.com October 2010 - April 2016
Regulatory Affairs Specialist
Executed strategic initiatives that expedited the drug development process by 20%
Developed IND applications for the FDA submission and achieved a 95% approval rate
Managed the preparation of regulatory dossiers for the Canadian market, achieving market entry in record time.
Pfizer January 2008 - September 2010
Quality Assurance Analyst
Established SOPs for the QA department, increasing efficiency by 25%
Led the implementation of CAPA to ensure compliance with company standards and regulations.
Novartis June 2005 - December 2007
Junior Regulatory Associate
Assisted in the preparation and submission of regulatory affairs documents, achieving 100% on-time submissions.
EDUCATION
Resume Worded Academic Center June 2010
Master's in Regulatory Affairs
Trained in global and regional regulatory affairs, pharmaceutical laws, and patent procedures
Resume Worded University May 2008
Bachelor of Science - Biotechnology
Specialized coursework included Genetics, Molecular Biology, and Biochemistry
SKILLS
Regulatory Skills: FDA and EMA Regulations, Post-Marketing Submission, Quality Auditing, Clinical Trial Management, Risk Assessment
Technical Tools: Microsoft Office Suite (Expert), TrackWise (advanced), Documentum (Expert), Adobe Acrobat Pro (Expert)
Languages: English (Native), Spanish (Conversational)
Quality Assurance: Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), CAPA Management
OTHER
Certifications: Certified Regulatory Affairs Professional (RAC), Certified Quality Auditor (ASQ)
Leadership & Volunteering: Organizer, PharmaCon Annual Conference; Mentor, Student Regulatory Affairs Society
Publications: Authored three articles on 'Navigating Regulatory Affairs' in PharmaBeat Journal

How do I add skills to a Regulatory Affairs Manager resume?

1
Review the job posting closely.

Go through the Regulatory Affairs Manager posting you're applying to, and identify hard skills the company is looking for. For example, skills like Standard Operating Procedure (SOP), Regulatory Affairs and Good Manufacturing Practice (GMP) are possible skills. These are skills you should try to include on your resume.

2
Add industry skills like Regulatory Submissions and Quality System.

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

3
Add skills into your work experience.

Incorporate skills - like Cross-functional Team Leadership, Biotechnology and Change Control - into your work experience too. This shows hiring managers that you have practical experience with these tools, techniques and skills.

4
Show examples of where you trained people.

On Regulatory Affairs Manager resumes, you should give specific accomplishments that involve you training others, whether that's in your team or other stakeholders.

5
Highlight leadership and management skills.

Hiring managers often want to see evidence of leadership and management on a Regulatory Affairs Manager resume, so try to include any examples of where you led a project or managed other people.

6
Use the exact job title.

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

Word Cloud for Regulatory Affairs Manager Skills & Keywords

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

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Regulatory Affairs Manager 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
Professional


Resume Example
Highlights (Free)


Resume Example
Modern Two-Column


Browse Skills from Similar Jobs

Frequently Asked Questions

What are the top skills you should add to your Regulatory Affairs Manager resume?

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

  • Regulatory Affairs
  • Regulatory Submissions
  • U.S. Food and Drug Administration (FDA)
  • Regulatory Requirements
  • Good Manufacturing Practice (GMP)
  • Standard Operating Procedure (SOP)
  • Validation
  • Quality System

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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