Regulatory Office Cover Letter

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

In my previous role, I was responsible for regulatory support and to undertake proper vigilance to ensure smooth execution of business activities from a regulatory and trade compliance perspective and that all activities are in compliance with applicable local and international laws, regulations and guidelines relevant to Life Science business transactions.

Please consider my experience and qualifications for this position:

• Advanced knowledge of regulatory information management, document management, document & submission publishing xEVMPD/IMPD, , concepts and systems, and workflow/process automation concepts and tools
• Language skills - fluency in ENGLISH together with a good command of SPANISH or ITALIAN or GERMAN or UKRAINIAN or POLISH
• Regular sitting for extensive periods of time
• Fluent Finnish language skills and very good English language skills
• Preference for SoCRA, ACRP, RAPS, or CIP certification
• Strong working knowledge of FDA, NCI, OHRP and/or ICH GCP
• Outstanding organizational skills, oral and written communication skills
• Knowledge of institutional, state and federal regulatory guidelines

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

Previously, I was responsible for guidance to project team members regarding regulatory compliance issues by providing independent regulatory guidance and support for strategic planning and compliance activities.

Please consider my experience and qualifications for this position:

• Proven track record partnering with Technology, Middle Office, Legal and Compliance to implement change and drive operational agenda
• Change management experience in initiatives designed to improve controls, reduce risk and maximize efficiency
• Prior Regulatory Reporting or change management experience working on Dodd Frank or EMIR deliverables highly desirable
• General knowledge of applicable local regulatory framework and its evolutions
• Knowledge of Compliance issues and challenges specific to his/her territory
• Self-confidence (independent mindset)
• Familiarity with internal business partner’s business, services and organization
• Fluent languages skills in German, French and Italian and good command of English

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

In the previous role, I was responsible for advice and recommendations to local RA Manager at local level on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.

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

• Minimum 1yr experience in hospital insurance regulatory billing, including Medicare, Medicaid and / or Labor & Industries (L&I)
• Manages projects with moderate regulatory oversight
• Project risk profile is low to medium
• Management direction or executive oversight is provided as necessary
• Resources where applicable to the project
• An in depth understanding of the regulatory landscape within the global financial services industry and practical experience of working in a regulatory environment, such as Compliance, Risk, Audit
• Conducting compliance reviews, understanding the controls environment and be able to credibly lead the QA function at a regional level
• Structured and organised approach, demonstrating a high level of diligence and attention to detail

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

Previously, I was responsible for assistance to the US Functional Heads in developing, setting and delivering regulatory strategy to the Regulatory Compliance and Financial Crime Compliance functions.

Please consider my qualifications and experience:

• SoCRA, ACRP, RAPS, or CIP certification preferred
• Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
• Outstanding organizational skills, and verbal and written communication skills
• Strong working knowledge of FDA, NCI, OHRP and ICH GCPs
• Prior senior management experience
• Sound knowledge of principles and practices of licence obligations and compliance standards
• Up to date with regulatory and market requirements (ASIC, AUSTRAC, APRA, ASX, FMA, FAA), industry association initiatives
• Preferred understanding of Cash and OTC derivative instruments with concentration in Credit asset class preferred

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

Previously, I was responsible for leadership and/or support in company initiatives and projects in a legal/regulatory expert role that may include the development of processes/procedures for handling new products/services/strategies, ensuring compliance with applicable rules/regulations, and gaining working knowledge of the specific areas within the organization and technology.

Please consider my experience and qualifications for this position:

• Exceptional attention to detail and quality outstanding editorial/proofreading skills
• Effective organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
• Advanced understanding of medical terminology, statistical concepts, and guidelines
• Holistic ownership and understanding of all Regulatory reporting requirements from a GSAM Operations perspective
• Ensure data accuracy and oversight in handling requests relating to Regulation and Audits
• Direct experience with FDA regulations relating to advertising and promotion for prescription products AND / OR product development process, including labeling development process
• Broad understanding of the process of pharmaceutical promotional development and review process