Coordinator, Regulatory Cover Letter

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

In my previous role, I was responsible for regulatory advice to cross-functional project on the regulatory requirements to support nonclinical/clinical document development (e.g., IB, protocols/amendments, ICFs, study reports, etc.) review, mindful of regulatory/ICH guidance/requirements pertaining to document content.

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

• Experience preparing and assembling FDA submissions
• Certification as a Clinical Research Coordinator or PMP certification
• Knowledge of tissue, cellular, and gene therapy
• Direct experience in regulatory affairs
• Coordinating activities within Argentina, working with Site Managers, Local Trial Managers and others to ensure regulatory compliance, Company SOPs, ICH-GCP and local regulatory requirements
• Intermediate English level is mandatory
• Strong safety awareness (safety standards and improvement)
• Enjoys working into a cross-functional environment

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

Previously, I was responsible for executable US FDA regulatory strategies, working knowledge of International regulatory strategy, and to deliver regulatory operations and compliance requirements.

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:

• Knowledge of evidence-based practice methodology
• Demonstrated proficiency/knowledge in appropriate software applications
• Basic knowledge of scientific concepts, terms, acronyms (pH, mg, ml, ) would be beneficial
• Effective communication skills, written and verbal, working with both internal and external customers
• Strong technical skills with excellent Microsoft Office Suite skills (Word and Excel)
• Demonstrated written, verbal, and interpersonal communication skills with an affinity for customer service
• Fluent in English and French, other languages are an advantage
• Pharma/medical background preferred

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

Previously, I was responsible for interpretation of relevant CMC guidances (ICH, FDA, EMA, etc) and provides prompt regulatory risk assessments and recommendations.

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:

• Has experience working with COFEPRIS and Ethics Committee
• Has contacts within the medical community
• Understands the general medical and clinical research practice in the Country
• Understands the international aspects of drug development process, including ex-pert knowledge of International Standards (GCP/ICH), Health Authorities (FDA, EMEA), local/ National Health Authorities regulations and Novartis standards
• Has previous experience implementing processes
• Has previous experience with the Corrective and Preventive Analysis
• Certification w/CCRC, CCRA, or RAC
• Information, Living Donor Registration Forms, Living Donor Follow-up Forms, Organ Specific Transplant Recipient

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

In my previous role, I was responsible for professional/technical guidance to various TriNet departments on matters related to the company’s licensure requirements and pending regulatory matters.

Please consider my experience and qualifications for this position:

• Proficient in using Microsoft Office applications including Word, Excel, PowerPoint, and Outlook
• General knowledge of protocol design
• Obtain and maintain certification in good clinical practice and hazardous material shipment)
• Regulatory Coordinator, research staff or IRB experience
• Able to be trusted with sensitive confidential information
• Communication-Oral and Written Communicates effectively one-to-one, in small groups and in public speaking contexts
• Performs regulatory submission/administrative duties for the Protocol Support Office, NCI/CCR
• Strong experience with various computer programs including MS Office tools including Word, Excel, PowerPoint

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

Previously, I was responsible for leadership in key regional and international committees and governmental/trade organizations engaged in policy decisions and global regulatory guidance development (e.g., ICH, WHO, PANDRH, BIO...).

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:

• Familiarity with US duty savings programs
• Understanding of Customs entry types and import processes such as inbonds, FTZ
• Advanced knowledge of MS Word and Acrobat
• Experience working with FCC, CE, and other EMC/RF/Safety global regulatory submissions
• Flexibility to support changing assignments and priorities in an independent and reliable fashion
• Experience in basic lab research
• Knowledge in epidemiological principles, infectious diseases , and sterilization, sanitation and disinfection practices
• Knowledge in adult education principles and patient care practices