Regulatory Coordinator Cover Letter

I would like to submit my application for the regulatory coordinator opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for regulatory support of clinical trials, local validation and verification trials and marketing trials.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Provide training internally
• Establishes confidence in one’s regulatory abilities and develops long-term trusting relationships with project team members and clients
• Should promote the professional growth of self to achieve individual and organizational goals
• Attention to detail (ATD)
• Experience in coordination and publishing of regulatory submissions for Investigational (IND, CTA) or Marketing Applications (NDA, MAA, NDS, MAA, 510k) to Global Health Authorities in eCTD, NeeS, or paper formats
• A working knowledge of Pharmaceutical Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA)
• Knowledge of evolving US regulations, guidelines, and specifications applicable to clinical research
• Strong computer skills and demonstrated knowledge of a variety of software programs (email, word processing, spreadsheet, database applications, Adobe Acrobat, web browsers, VELOS, REDCap)

In response to your job posting for regulatory coordinator, I am including this letter and my resume for your review.

In my previous role, I was responsible for regulatory guidance and advise on clinical research in Canada as requested from local and global colleagues; be knowledgeable on Health Canada Regulations, Guidances and processes.

My experience is an excellent fit for the list of requirements in this job:

• Experience with policy administration desirable
• Able to work independently collaboratively with all levels of the organization
• Handles tasks with competing and conflicting requests
• Experience as program coordinator role, group facilitation, nursing leadership or educator desirable
• Computer skills including power point, database development, data display and analysis preferred
• Experience in performance improvement methodology and teamwork principles
• Exercises judgment and tactful discussion on regulatory standards with colleagues, managers, directors and medical staff
• Written and verbal communication that is clear and concise

I submit this application to express my sincere interest in the regulatory coordinator position.

In the previous role, I was responsible for education to the Winship community and CTO personnel in all aspects of clinical trials regulatory compliance.

Please consider my experience and qualifications for this position:

• Research and critical thinking skills
• Experience with proactive privacy auditing and monitoring, analyzing trends, monitoring changes and remaining current on local, state and federal regulatory requirements
• Experience developing recommendations to mitigate risk, identifying areas where changes to organizational practices, policies or procedures might be needed to enhance organizational effectiveness and ensure consistency in preparation for future audits
• Experience working with enterprise databases and analytics
• CHC, CPC/CCS certification preferred
• Coding Certification (AAPC or AHIMA), knowledge of Soarian, Power Chart and other Cerner applications, knowledge of Compliance 360 and knowledge of FairWarning or other privacy monitoring solutions preferred
• Good Clinical Practices (GCP) knowledge preferred
• Has experience in CROs or Clusters managements

I would like to submit my application for the regulatory coordinator opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for training and guidance with regard to policies and procedures that are related to the conduct of NCTN LAPS clinical trials.

My experience is an excellent fit for the list of requirements in this job:

• Assists in preparation for any RFIs for clinical approvals of the programs
• Attends and participates in meetings and staff in-services
• Completes mandatory continuing education activities such as the UNOS national meeting or others as identified to maintain expertise in regulatory matters specific to transplant
• Write or revise Standard Operating Procedures
• Develop and write responses to External Regulatory Agency Citations
• Work with other parties in business to develop CAPAs
• Advanced skills with MS Office - Excel spreadsheets, MS Word documents / templates
• Highly organized, detail oriented and able to multi-task based on changing priorities

Please consider me for the regulatory coordinator opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for support for entering clinical trials protocol information and study results into the NIH Clintrials.gov database ensuring that the database is kept current and accurate.

My experience is an excellent fit for the list of requirements in this job:

• Cargo experience preferred
• Typical level of education includes a high school diploma or GED
• Able to communicate, both verbally and in writing, in a clear and concise manner
• Able to utilize mainframe and/or personal computer systems and software proficiently, such as electronic mail, spreadsheets and word processing software (currently Internet Explorer, SharePoint, and Microsoft Office – , Word, Excel, PowerPoint and Outlook)
• Able to learn and to apply knowledge of CNP’s corporate policies and procedures
• Knowledgeable is using electronic communication media and familiarity with web based enterprise level software
• Industry knowledge of vendor reviews and subject matter expertise in consumer regulations
• Familiarity with import clearance processes in Canada, USA, Europe and/or other countries