Regulatory Associate Cover Letter

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

In the previous role, I was responsible for support to regulatory compliance activities, including drug listings, global facilities registrations and maintaining local/state site registration.

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

• Strong knowledge of various financial products
• Food labeling law certificate and/or certification issued by an accredited university preferred
• To assist in the creation of project planning, analysis & UAT in support of changes to the Risk Platform(FRANK) in relation to existing reporting or new reporting requirements within SAS and OBIEE
• Engage with customers and stakeholders in and outside of GFS UK to correctly investigate and communicateany changes to the Risk Platform (FRANK)
• Engage with customers and stakeholders in and outside of GFS to correctly investigate and communicate anychanges to the Risk Platform
• SAS/SQL/OBIEE experience is highly desirable
• Good understanding of relevant risk policies and external regulatory reporting requirements and Basel ii/iii in order to ensure that the reports and the reporting environment conform to internal and regulatory requirements
• Have a good understanding of how to motivate people and to get to the heart of the matter

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

In my previous role, I was responsible for initial regulatory assessment, develop/author appropriate regulatory submissions to ensure timely and appropriate registrations for new products, handle regulatory product life cycle management activities, and provide regulatory support on international submission/product registrations.

Please consider my qualifications and experience:

• Well trained for Regulatory Affairs
• Support establishing short & long term strategic plans for new product registration
• Product registrations, maintenances and renewals
• Work as a core member of product development
• Maintain good relationships with BOH and act for regulation innovations
• Information management and sharing with related parts
• Approvals of artworks, marketing materials or activities
• Coordinate third parties for registrations or product maintenances

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

In the previous role, I was responsible for global regulatory leadership, management, and functional expertise to submissions managers in PDRO Regulatory Submission Portfolio team accountable for submissions management of regional and/or national regulatory dossiers to Health Authorities.

Please consider my experience and qualifications for this position:

• Hard-worker, committed to timelines and accuracy of submissions
• Working knowledge of applicable regulations and guidances including current Office of Generic Drugs submission requirements, ICH, cGMP
• Some regulatory operations experience (submission compilation and publishing) is preferred
• RA Certification (RAC) is preferred
• Experience with excel, VBA code, and SAP
• Experience with data collection for submission, preparing submissions, corresponding w/ regulatory agencies and stakeholders, monitor timelines preferred
• Previous training and certifications related to transportation compliance
• Prior experience authoring Safety Data Sheets

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

Previously, I was responsible for input for regulatory requirements and regulatory registration strategy for product development and product changes to ensure timely submission and approval.

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

• Develops and maintains documentation relevant to current healthcare regulations
• Tertiary qualification in Science
• Background in health sciences desirable
• High level of project and time management
• Expertise with Sharepoint
• Proven track record in delivering projects
• Leveraging Internal & External Networks
• Clear and concise communication abilities both verbal and written

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

Previously, I was responsible for regulatory support to local business including timely NPD RA assessment, regulatory strategies inputs, new product registration and notifications to support new product launches in time for all franchises and product license maintenance or regulatory issues during the product life cycles.

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:

• Previous experience in regulatory affairs, pharmaceutical drug development or life sciences
• Basic understanding of scientific and medical principles as they apply to oncology products is preferred
• Basic working understanding & knowledge applying medical device/IVD regulations of FDA and International regulations (ideally including EU)
• Team oriented with an enthusiastic attitude and strong interpersonal skills and a basic understanding of project management, problem-solving and risk management
• Background in molecular diagnostics preferred
• Previous regulatory experience with Clinical Trials in Pharma/CRO
• Great attention to detail and proofreading abilities
• Work well in a group setting with a variety of employees