Regulatory Operations Cover Letter

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

In my previous role, I was responsible for leadership to determine and execute technical solutions to support electronic submissions within OECD guidelines and optimize the electronic exchange of data to and from regulatory authorities;.

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:

• Pro-active and able to drive regional agenda to link into global initiatives
• Debt product trade support, middle office or settlement experience
• Skilled in Microsoft Office software, including Word, Excel, and Access
• Exposure to numerous DB businesses
• A thorough understanding of a wide number of securities & cash products & external market institutions
• Extensive senior client contact both internal and external
• Basic knowledge of pharmaceutical development and regulation
• Working knowledge of FDA medical device regulations

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

In the previous role, I was responsible for technical assistance to colleagues in the utilization of the electronic submissions software, as well as other document creation tools e.g.

Please consider my experience and qualifications for this position:

• Understanding of the CTD structure FDA and ICH specifications for eCTD submissions
• Strong Microsoft Excel skills knowledge of all other Microsoft Office applications
• Proficient in Microsoft Windows environment including, but not limited to, Microsoft Office products
• Willingness to work on weekends and public holidays
• Willingness to work in shifts (within the allowable working time frame)
• Able to work under stress with high quality
• Best in class working style – high quality consciousness
• Expertise in MS-Office tools (Word, Excel, PowerPoint)

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

Previously, I was responsible for centralized support for document upload and data entry in operational and document management systems (e.g., CTMS, clinical trial and budget tracking, electronic Trial Master File (eTMF), electronic document management system (EDMS) etc.).

Please consider my experience and qualifications for this position:

• Hotscan Review and Release of messages
• Understanding of the principals of project planning and execution
• Continual training to stay abreast of changing regulations
• Leverage GRA’s internal resources to support conformance and cost-effectiveness
• Lead or support process improvement with aim toward simple and efficient delivery
• Support delivery of OCRO’s business objectives
• Maintain compliant and efficient operating standards and key performance indicators/metrics for all OCRO Functions
• Support OCRO “Air Traffic Control” to support governance (prioritization, decision-making, ROI) for Function and matrix team work, projects, and improvements

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

In the previous role, I was responsible for roche input on new regulations, health authority pilots, user acceptance testing of health authority systems and to impart advice on electronic submissions.

Please consider my qualifications and experience:

• Knowledge of food / Pharma Registration and submission process in the AfME pacific region
• Understand the local / regional regulatory guidelines and requirements for specified product line(s)
• Maintains positive and cooperative communications and collaboration with all levels of employees worldwide
• Knowledge of EDM, RIM and electronic publishing software preferred
• Experience compiling, publishing, validating and submitting in eCTD for various submission types
• Strong knowledge of EDM, RIM and electronic publishing software preferred
• Current Pharmacy Student with strong technical computer skills
• Interest in learning more about the role of the Regulatory Affairs function within the Pharmaceutical Industry

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

In the previous role, I was responsible for support of the regulatory function through document management, electronic submission compilation and management, and other group management activities.

Please consider my experience and qualifications for this position:

• Any certifications in the OFAC Sanctions or AML area will be appreciated
• Comprehensive knowledge of pharmaceutical drug development process
• Able to manage productivity responsibilities
• Knowledge of IND, NDA, MAA, CTD requirements and guidelines
• Understanding of U.S. submission requirements
• Proficient with Microsoft Office products and Adobe Acrobat
• Knowledge of regulatory affairs, performance management and the external RA outsourcing market
• Experience of global regulatory affairs from the pharmaceutical and/or healthcare industry and ideally from regulatory services providers