Regulatory Specialist Cover Letter

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

In my previous role, I was responsible for direction to regulatory affairs staff responsible for the review and approval of promotional materials and labeling for products.

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

• An innovative frame of mind – open to applying creative techniques to find a solution
• Execution - persistent drive for results utilising sound project focus, organisational and problem solving skills
• Comprehensive understanding of biological and chemical WMD safety and security requirements, and experience effectively implementing requirements related to Federal (CFR), State and Army Regulations/laws
• Extensive knowledge and experience interpreting DoD/DA regulations
• Knowledge of GLP and AAALAC requirements to support a research facility that specializes in chemical and biocontainment research
• Hedge Fund accounting and/or regulatory experience
• Experience assisting with authoring, contributing and/or reviewing technical documents/product documents for new or modified regulated products, and/or has experience creating an assessment of compliance or evaluated the impact to current regulatory status (clearance, registrations, licenses, or approvals) of process or products
• Understands Quality System Regulation submissions and the documentation needed to support it

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

Previously, I was responsible for regulatory guidance and direction as the senior regulatory affairs project lead, supporting external customers with regulatory projects throughout the product development life-cycle.

Please consider my experience and qualifications for this position:

• Knowledge of ISO continuous improvement and controlled document methodologies and processes
• Experience with ITIL-based processes service delivery methodologies
• Experience with health care and/or federal government regulatory bodies and auditing methods
• Strong submissions experience
• Experience in the field of RA desirable
• Track record of working with authorities, distributors are desirable
• Competence of managing ambitious timelines
• Proven to be able to take decisions and remain accountable for their results

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

In the previous role, I was responsible for regulatory assistance for tenders and support daily business from regulatory affairs perspective in accordance with Janssen guidelines and local laws & regulations.

Please consider my experience and qualifications for this position:

• BS in science or engineering program
• Regulatory and/or quality experience in chemical, medical device and/or pharmaceutical products
• Work effectively with other team members to solve problems and implement solutions
• High communication interpersonal skills
• Support Global Regulatory Managers and Regulatory Chemistry experts by preparing standardized assessments, data summaries, data sheets, dossiers and other documentations which are accurate, complete and consistent with company standards
• Awareness of product registration requirements and regulatory science issues and preferably
• Current working knowledge of Microsoft Suite and Windows
• Draft letters, comments, responses to queries and other communications for submission to the regulator and other relevant ministries regarding telecommunications regulatory issues

I am excited to be applying for the position of regulatory specialist. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for strategic regulatory direction on the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments, critical issue management.

Please consider my experience and qualifications for this position:

• Demonstrates strong writing and communication skills
• Able to identify risk in Regulatory strategies
• Excellent use of Microsoft Office applications
• Knowledge of submission standards in various formats
• Knowledge of good documentation practices and requirements for managing regulated records
• Capable of utilizing IT systems supporting regulatory affairs such as document management, electronic publishing, and submission systems (e.g., SharePoint, Documentum, InSight Publisher)
• Skilled in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project)
• Excellent written and oral communication skills to effectively observe, question, extract, document, and present information to associates at all levels within the organization

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

In my previous role, I was responsible for regulatory review and approval for domestic and international promotional material review, and regulatory guidance as needed.

Please consider my qualifications and experience:

• Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards
• Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
• Knowledge of Microsoft Office, excel, power point, Internet
• Abilities to work in an ever changing environment and changing priorities
• Flexible, team player, positive attitude and willingness to always learn more
• Experience with FDA QSR and ISO13485 requirements and experience in FDA and quality system implementation
• Solid working knowledge of FDA and international medical device regulations
• Auditor certificate preferred