Regulatory Cover Letter

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

In the previous role, I was responsible for consultation and advice to internal and external clients on regulatory requirements for global drug development (for US and EU), either by own knowledge or by consultation with global experts and SMEs.

Please consider my qualifications and experience:

• Relevant work experience in an administrative or research work environment
• Experience working directly with quality R&D, manufacturing, and marketing departments
• Experience reviewing project deliverables
• Experience working with the Design Control process and related procedures
• Excellent written, verbal, interpersonal and management skills with proficient use of computers, especially the Microsoft Office suite of applications
• IACUC related experience
• Certified Professional IACUC Administrator (CPIA), AALAS Laboratory Animal Technologist (LATG) certification, or certification eligible
• Knowledge of federal and state regulations pertaining to the use of animals used in research is preferred

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

In my previous role, I was responsible for oversight of FDA establishment registration, drug product listing, and import procedures in collaboration with Regulatory Labeling and Advertising and Promotion Manager, US.

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

• Hands-on experience in the inspection, quality assurance, regulation or validation of pharmaceuticals, food, dietary supplements, or other FDA regulated products
• Basic knowledge of FDA and EU CMC regulatory requirements
• Experience with preparation of CMC submissions (INDs, IMPDs, amendments, BLA/MAA)
• Proficiency with Electronic Document Management Systems, preferably Documentum, and publishing tools such as Adobe Acrobat
• Strong computers skills and comfortable with documentation systems
• Experience drafting and reviewing product labeling and compiling supportive documentation
• Strong appreciation of the value of standard policies and procedures
• Basic understanding of industry recognized service delivery standards and methodologies, and associated regulatory agencies and guidelines

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

In my previous role, I was responsible for regulatory guidance and assistance in a timely manner regarding scientific and regulatory problems, issues, concerns, questions, and strategies associated with the drug-development process.

Please consider my experience and qualifications for this position:

• Knowledge of biomedical terminology and experience in doing research is highly desirable
• Strong communication skills, dynamic and flexible
• Working level English or higher
• Follows specific instructions and procedures for assigned tasks
• Active CQA certificate through ASQ preferred
• Understanding of outline of regulation
• Knowledge of the principles of regulation or experience in specific area of regulatory area
• Good understanding of the significance of scientific data in regulatory context

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

In my previous role, I was responsible for strategic and tactical CMC regulatory guidance relating to global drug development, serving as Subject Matter Expert for EU-based regulatory submissions and key point of contact for Syneos clients and for internal Syneos teams.

Please consider my experience and qualifications for this position:

• Problem solving to meet timelines
• Previous experience in Advertising and Promotion Operations
• Knowledge of eDocs doc base
• Provide support through research of international best practices, analysis of regulatory trends and other information for development of complex documents such as responses to public consultations, regulatory audits and other queries issued by the regulator
• Support the regulatory team on managing wholesale relationships with other licensed operators, such as interconnection, access to telecommunications facilities and sharing of radio sites and other passive infrastructure
• Support efforts of regulatory team to ensure sales and marketing and other activities of the company are in compliance with the Telecommunications Law and the Applicable Regulatory Framework
• High level of personal integrity, interest in the law, education, and technology
• Strong analytical skills and common sense are critical

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

In my previous role, I was responsible for regulatory affairs support by preparing labeling and supplements for FDA drug dossiers for new product presentations or lifecycle changes.

Please consider my experience and qualifications for this position:

• Knowledge of IMMEX Program
• Knowledge of import/export trade regulations, tariff schedule, incoterms, free trade agreements, VAT Certification, security programs and import/exports customs operation
• Strong computer skills (SAP or other ERP related software, MS Office Suite)
• Knowledge of SAP-GTS Systems
• Technical writing or Technical support (MS-Word) experience
• Be able to take on other projects as necessary
• CMC experience, technical validation knowledge is helpful
• Knowledge of GMP manufacturing practices in Vaccine or regulated environment