Regulatory Management Cover Letter

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

Previously, I was responsible for advanced regulatory knowledge of eSubmission-specific requirements for worldwide regulatory submissions and apply to internal and external standards and strategies.

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:

• Understanding of current product offerings in order to identify changes needed as a result of legislative and regulatory actions changing needs of plan sponsors and/or participants
• Proficient in Microsoft Suite (Outlook, Excel, Word, PowerPoint)
• Lead facility staff in completion of facility EH&S risk assessment addressing all media/concerns (air, water, waste, industrial hygiene, safety, ergonomics, fire protection)
• EHS-related certification (CSP, ASP, ), preferred
• Microsoft desktop suite (Outlook, Word, Excel, Visio, Powerpoint)
• Database (Regulatory database Miss Amm, Liquent Insight, Aris Register or equivalent would be appreciated) and electronic document management system (Documentum and any overlayer/user interface on top of Documentum would be appreciated)
• Acrobat pro software
• Experience in medical industry regulations

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

Previously, I was responsible for ad hoc analysis of AA, RWA and RC changes arising from changes in methodology, risk parameters and regulatory requirements etc.

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

• Experience of working in complex environments (sensitive to the internal organization and creating support and acceptance)
• Strong persuasiveness skills
• Sensitive and a good listener
• The will and mind set to continuously want to improve
• Prior experience working claim denials for WA
• Demonstrate sound judgement regarding regulatory issues, based on strong knowledge and understanding of the key objectives, concerns, and trends of host regulators
• Have strong coordination, delivery and analytical skills, in conjunction with attention to detail
• Be able to thrive in an environment working remotely from the rest of the team - will be sole member of team based in Singapore

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

Previously, I was responsible for regulatory affairs support to design and change control teams to assess regulatory impact of design changes including and manufacturing production line transfers.

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

• Experience with the FDA regulations pertaining to pharmaceuticals/ISO experience and Quality Management Systems is desirable
• Master in life sciences or related science / engineering background with a strong emphasis in biopharmaceuticals / biologics
• Broad and extensive regulatory knowledge of Korea laws and regulations in pharmaceuticals and cGMP
• Excellent interpersonal, presentation, listening and communication skills
• Experience in thought leadership
• Regulatory experience in the EU or one of the MS’s
• Planning, project management and problem solving skills
• Demonstrate sound judgements regarding regulatory issues, based on strong knowledge and understanding of the key objectives, concerns, and trends of host regulators

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

Previously, I was responsible for assistance in keeping abreast of changes and proposed changes to the worldwide regulatory requirements related to company products and processes.

Please consider my experience and qualifications for this position:

• Able to strike balance between being accountable and escalation
• Excellent communication skills (oral and written) which can be applied in a range of contexts and with different stakeholders
• Experience gained in managing and organising operational activities and coordinating across divisions
• A university level education with a preferred specialisation in Compliance or Tax
• Affinity with data, (advanced) analytics and technology within the financial services sector with working knowledge in the sector an advantage
• Preferably experience in establishing FATCA, CRS, QI or FEC compliance policies and procedures in a cross border environment
• Strong consultancy skills including excellent communication and presentation skills and fluent in the English language
• Strong coaching skills are important

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

In the previous role, I was responsible for product information to internal and external customers with respect to domestic and foreign regulatory requirements in the area of FDA regulations and related laws.　.

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

• Regulatory certifications preferred
• Broad-based knowledge of financial services operations and controls
• Excellent organizational, analytical, project management and problem solving skills with a strong attention to detail
• Experience working on multiple concurrent projects and under tight deadlines and demonstrated proficiency in meeting established deadlines
• Solid proficiency in basic computer applications (MS Office)
• Knowledge and understanding of the key objectives, concerns and trends within both the FCA and the PRA, a focus on PRA would be beneficial
• Demonstrates an understanding of how the UK Regulators think about issues, with a broad perspective on issues impacting the European Union more generally
• Confident in delivering and handling difficult messages and situations, both internally with Senior management and externally with the Regulators