Regulatory Assistant Cover Letter

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

In the previous role, I was responsible for guidance to investigators and coordinators regarding Good Clinical Practices (GCPs) in research involving human subjects.

Please consider my qualifications and experience:

• Experience in previous implementation of CCAR / DFAST process
• Professionalism in interdepartmental and customer contact
• Working knowledge of Excel, PowerPoint, Adobe Acrobat and GIS software
• Advanced MS Word skills including experience with applying custom styles and using equation editor
• Experience with manipulating size and resolution of electronic images
• Experience with electronic libraries, databases, data analysis, file naming conventions and metadata
• Enforce a robust T+1 control environment charged with the follow-up and resolution of operational exceptions across all GMO functions and geographies
• Senior Subject Matter Expert with an in depth knowledge of at least of one covered function within a Broker Dealer Stock Loan, Settlements, Possession and Control, Margin, Purchase & Sales, Trade Confirmation

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

In my previous role, I was responsible for strategic and operational leadership to Marketing Brand Teams, Legal, Medical Affairs and Clinical in the development of advertising and promotion for the US market (for major company assets) in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and company policy.

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

• Work with Lead Global Regulatory Strategist and supervisor to compile and submit IND and clinical trial applications to enable timely start of the clinical trials for the assigned development products
• Work with Lead Global Regulatory Strategist and supervisor to develop submission materials for local Health Authorities guide the review process, check for accuracy, scientific consistency, compliance to local Health Authorities regulations and completeness of submission
• Collect, review and analyze competitor information, local Agency guidelines and precedence
• Keep up to date of changes in the local regulatory environment for the project
• Contribute to the development of the Briefing document for the local authority meeting for assigned projects
• Enter submission material, documents and relevant data into appropriate Regulatory Affairs databases
• Share in decision making on key development questions as needed
• Participate in ad hoc Global Project Team, sub-teams or working groups as invited by the Global Project Team

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

In the previous role, I was responsible for regulatory guidance and direction to investigators and all members of the research team in order to ensure compliance with all internal, external and federal policies, including UCD and affiliates, FDA, OHRP, COMIRB, GCP, and regulations that apply to research involving human subjects.

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:

• Excellent communicator, able to easily engage counterparts and foster collaborative relationships across teams and global boundaries
• Skilled at managing and interacting with Audit, Inquiry and Exam Reviews conducted by internal parties and regulatory bodies such as FINRA, SEC, FRB & NYSE
• Strong attention to detail, with a highly ethical and control mindset
• Strong sense of urgency to drive issue resolution and correction in a timely manner
• Highly organized and results driven, focused on the resolution of exception items
• A good understanding of the Equities & Derivatives Market Structure
• SQL and data extracting skills
• Basic knowledge in Asia food regulations

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

In my previous role, I was responsible for strategic and operational leadership to Marketing Brand Teams, Legal, Medical Affairs and Clinical in the development of advertising and promotion for the US market (for major assets) in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and corporate regulations, policy, and guidance.

Please consider my qualifications and experience:

• Experience in communication on Nutritional Health Claims will be an added advantage
• Excellent command of English in both written and spoken communication
• Proficient in MS Office and computer applications
• Proficiency in the Microsoft Office suite of products and Lotus Notes
• Undergraduate research experience with human participants (not just lab setting)
• General knowledge of global/ regional/ national country requirements/ Regulatory Affairs Procedures for Clinical Trial Authorization is an asset
• Contribute to the development of local regulatory project goals from development through life cycle
• Participate in preparation for meetings and teleconferences with local Health Authorities officials

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

In my previous role, I was responsible for tools, processes and guidelines to support planning and execution of global filing and Health Authority interactions.

Please consider my experience and qualifications for this position:

• Previous CTA experience
• Archiving and records management for regulatory information
• Conversion of hard copies of documents to electronic archiving
• Regulatory and/or scientific data/information searching
• Entry of regulatory document information to electronic databases and filing of information
• Excellent computer skills with word processing, spreadsheet, and database software
• Formulate and pursue all aspects of investigations into potential breaches of the AIM Rules by AIM companies and Nominated Advisers including case strategy and scope and the gathering of evidence
• Manage communications with Nominated Advisers and AIM companies under investigation and their representatives