Director Of Regulatory Affairs

Director Of Regulatory Affairs Resume Keywords and Skills (Hard Skills)

Here are the keywords and skills that appear most frequently on recent Director Of 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)
  • Biotechnology
  • Drug Development
  • Clinical Development
  • Clinical Trials
  •  Find out what your resume's missing
  • IND
  • Regulatory Requirements
  • Good Manufacturing Practice (GMP)
  • Standard Operating Procedure (SOP)
  • Validation
  • Biopharmaceuticals
  • Life Sciences
  • Oncology
  • Electronic Common Technical Document (eCTD)
  • Corrective and Preventive Action (CAPA)
  • Good Clinical Practice (GCP)
  • CMC
  • U.S. Title 21 CFR Part 11 Regulation

  •   Show full list

Resume Skills: Technical

  • Microsoft Office Suite
  • TrackWise
  • Documentum
  • Adobe Acrobat Pro
  • SAP
  • Regulatory Information Management System(RIMS)
  • Document Management Systems(DMS)
  • eCTD Submissions
  • GCP
  • GMP
  • GLP
  •  Match your resume to these skills

Resume Skills: Regulatory

Resume Skills: Languages

Resume Skills: Quality Assurance

Resume Skills: Regulatory Knowledge

Resume Skills: Project Management

  • Agile Methodologies
  • Scrum
  • Lean Six Sigma (Green Belt)
  • Project Coordination
  • Stakeholder Management
  • Time Management
  • Cross-functional Team Leadership
  •  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 Director Of 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 Director Of 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
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 Director Of Regulatory Affairs resume?

1
Review the job posting closely.

Go through the Director Of Regulatory Affairs posting you're applying to, and identify hard skills the company is looking for. For example, skills like Regulatory Affairs, IND and U.S. Food and Drug Administration (FDA) are possible skills. These are skills you should try to include on your resume.

2
Add industry skills like Drug Development and Clinical Development.

Add other common skills from your industry - such as Regulatory Submissions, Biotechnology and Clinical Trials - into your resume if they're relevant.

3
Add skills into your work experience.

Incorporate skills - like Electronic Common Technical Document (eCTD), Corrective and Preventive Action (CAPA) and CMC - into your work experience too. This shows hiring managers that you have practical experience with these tools, techniques and skills.

4
Highlight leadership and management skills.

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

5
Use the exact job title.

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

Word Cloud for Director Of Regulatory Affairs Skills & Keywords

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

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Director Of 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
Professional


Resume Example
Highlights (Free)


Resume Example
Modern Two-Column


Browse Skills from Similar Jobs

Frequently Asked Questions

What skills should you put on a Director Of Regulatory Affairs resume?

Some effective Director Of Regulatory Affairs skills you can add to your resume include:

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

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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