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Regulatory Affairs Coordinator Resume Sample
Regulatory Affairs Coordinator
Highly structured, problem-solving, motivated, and responsible certified pharmacist in Denmark. Recently, specialized in regulatory science graduating with a master in Pharmaceutical Science from the University of Copenhagen 2018. Offering broad experience within regulatory affairs, clinical trials, labeling, and real-world evidence combined with project management skills. Work both independently and in a multidisciplinary team with the ability to communicate in a cross-cultural organization.
- Regulatory Affairs
- Clinical Trials
- Real-World Evidence
- Project Management
- Analytical Mindset
Regulatory Affairs Coordinator
Margo Surgical LLC
- Set regulatory strategy for changes implementation worldwide
- Registration worldwide
- Follow-up with guidance and regulation worldwide
Regulatory Affairs and Real-world Evidence Data analyst
Davin Cooper LLC
- Analyzed label, guidance, regulation, and approval decisions in EU-EMA and US-FDA to identify trends and gaps or alignment in their current regulatory strategy and to explore new approaches toward a new regulatory strategy that will not only influence EMA and FDA regulations but also regulations worldwide.
- Interpreted regulatory guidance and clinical trial study design for both EU-EMA and US-FDA to investigate a new approach in developing clinical trials that generate effective clinical outcomes that meet patient needs.
- Responsible for questions received from EMA, FDA, and Switzerland during NDA assessment and for the phase 3a program.
- Identified trends among labels (CCDS, ENDS), prescription leaflets, and patient information documents.
- Organized and prepared successful workshops for professionals discussing label changes.
- Prepared non-EU label documents (ENDS).
- Analyzed EMA and FDA approval decisions that were based on submitted clinical trials to identify trends and gaps or alignment in their clinical trial development approach.
- Proposed alternative clinical study design for clinical drug development of fixed-dose combination products that are effective and aligned with patient needs in real-world clinical practice.
- Collaborated with Danish community pharmacists to collect for first time patient-reported outcomes (PROs) in real-world clinical practice that is to compare the PROs in clinical practice versus PROs collected in controlled clinical trials.
- Designed and developed a patient-based questionnaire to collect real-world PROs that are distributed to the pharmacists and trained in how to use the questionnaire and communicate with patients.
- Ongoing voluntarily collecting and analyzing real-world evidence (RWE) represented by PROs on fixed-dose combination product called (Xultophy) in collaboration with the University of Copenhagen and Danish community pharmacies network.
MSc. In Pharmaceutical Science
University of Southern California
BSc in Pharmacy (5 years)
Northeastern University Boston, Massachusetts
Career Expert Tips:
Regulatory Affairs Coordinator Resume with Writing Guide
Becoming a certified professional can have huge benefits for your personal and professional life. In this blog, we will show you how to write the perfect Regulatory Affairs Coordinator Resume that will get noticed and lead you in the right direction. Start by downloading this sample pdf to learn more about what type of skills you need on your resume in order to join our growing industry as a regulatory affairs coordinator. We will also be providing you with a guide to customizing your resume and tips from industry professionals.
How to Write the Perfect Regulatory Affairs Coordinator Resume
The perfect Regulatory Affairs Coordinator Resume is much more than a simple list of job experiences. It should create an image in the employers’ mind, painting a picture of your skills, work ethic, and personality. Create a resume that stands out among the rest by following this step-by-step guide to writing your perfect Regulatory Affairs Coordinator Resume.
Highlight your education and career experiences, including your most valuable skills. Your resume will look incomplete without any background information that allows employers to understand you as a person. You will need to put details like education, work experience, and employment dates on your resume for it to be truly effective.
Include references and dates of employment, but make sure that they are relevant. You will want to include your references as well, but they should be relevant. Listing references that have worked with your past companies will help to provide additional credibility for your resume.
Use action verbs in the right sentences for greater impact. The verbs you use in your sentences on your Resume must describe what you have actually done during each job and not just what you have been capable of doing.
Create a list of skills that will display your value to the company as well as the regulatory affairs field as a whole.
List of Typical Responsibilities For a Regulatory Affairs Coordinator Resume:
- Review and approve product chemistry data and other submission documentation prior to submission to the FDA or other regulatory agency
- Responsible for ensuring all regulatory documentation is appropriately filed according to company procedures
- Work with the Quality Control group to ensure that adverse event reports are properly generated, reviewed, and recorded in accordance with FDA rules and regulations
- Provide assistance in creating a timeline for regulatory documents
- Review all clinical trial results from site visits prior to their submission for approval by the FDA or other regulatory agency
- Advise the investigator of documentation requirements for all investigations
- Provide member support to regulatory personnel during new product approval process
- Ensure that the company’s warning letters have been appropriately reviewed and filed
- Provide current regulatory information pertaining to the industry to investigators in anticipation of potential FDA questions during clinical trials
- Distribute FDA drug product labeling at manufacturing facilities
- Personally conduct HACCP training at manufacturing facilities when requested by the Quality Control manager or Food Safety Manager
Top 10 Must-have Regulatory Affairs Coordinator Skills:
- Comfortable Conducting Technical Interviews
- Familiarity with Industry Standards and Regulations
- Experience Utilizing Statistical Data for Product Development
- Familiarity with Manufacturing, Packaging, and Distribution Systems
- Excellent Written and Verbal Communication Skills
- Experience with Regulatory Compliance Issues
- Familiarity with Software Tools for Regulatory Affairs
- Working Knowledge of the U.S. Food and Drug Administration (FDA) Regulations
- Effective Training Skills
- Familiarity with Global Regulatory Practices
Tips to write a Regulatory Affairs Coordinator Resume Summary:
- A summary of the applicant’s experience is crucial to a successful hiring process. It will provide the reader with an overview of your background and qualifications in just one or two sentences.
- Focus on how you’ve been able to produce results in the past, consistently meeting your goals. Talk about the responsibilities you’ve had, exactly what each position entailed, and how your skills translated into tangible results that were important for your organization.
- Highlight skills and accomplishments that are relevant to your desired position. Skills are important because hiring managers want to know if you can do the job.
- In addition to your skills, including information about your education and training. This is a good place to briefly elaborate on how each school or experience advanced your knowledge or skills, especially as it relates to the job you’re applying for.
- Talk about any obstacles you’ve overcome and any results that speak of your successes in overcoming them.
How to write a Regulatory Affairs Coordinator Resume with No experience:
- Take the time to read [and follow] the guide below.
- Give yourself some thought about whether or not you will be the type of candidate who needs no experience.
- If you are, take the time to write down what types of jobs you want to be doing in 2-5 years from now, or 5-10 years from now, etc., and how your resume will reflect that.
- If you are not, then take the BONUS TIME to focus on including all of the skills and experiences relevant to a Regulatory Affairs Coordinator position, whether or not they are related to your current career.
- Use a professional resume template
How to write a Regulatory Affairs Coordinator Cover Letter:
- Use “I” statements to demonstrate an ability to work independently.
- Include your accomplishments in the present tense.
- Use summary statements at the end of your cover letter to list achievements and outline professional goals.
- Be specific when describing your experience, skills, and qualifications
- Highlight your key strengths in the accomplishments section of your cover letter: goal setting, leadership, technical competencies, communication skills, and time management are all important qualities that a potential employer will be looking for in a regulatory affairs coordinator candidate .
- The resume and cover letter are the only two documents you need. They are the only two documents you need to get your foot in the door and stay there!
- A job interview without a cover letter is like an AM radio station without a signal!
- Don’t send both to the same employer at the same time, unless you have discussed it ahead of time with them!
- The new federal government will be releasing regulations at an alarming rate, and they are often larger in scope than the companies that are expected to comply with them.
- Companies cannot afford to have a Regulatory Officers do not cover every aspect of their operations, so only staff who have the appropriate experience will be promoted to Senior Regulatory Scientist positions.
- New laws and more complex rules will require skills and experience that were not being asked for before.