Senior Manager, Regulatory Cover Letter

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

In my previous role, I was responsible for regulatory labeling (manuals, instructions for use, labels, etc.) guidance, review and approval for assigned products taking into account regulations, standards and cleared/approved product claims.

Please consider my experience and qualifications for this position:

• Proficient with MS Project, Word, PowerPoint, and Excel
• Solid understanding of FDA regulations and ICH guidance comprehension of the drug development process
• Working knowledge of Process Mapping and Business Architecting, including use of related software and tools
• Experience in multi regional regulatory agencies/pharmaceutical industry
• CMC knowledge in specific subject area
• Manage all aspects of multiple projects varying in scale and complexity
• Works with client or internal client managers to define project scope, schedule and budget
• Leads safety efforts including preparation and compliance with approved safety plans

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

In my previous role, I was responsible for cMC information for investigational products and medical devices used in clinical trials in China.

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:

• Demonstrated success in the preparation and completion (including negotiations) of regulatory submissions (PMA, 510(k), IDE) to FDA and other regulatory agencies
• Demonstrated project management, negotiation, and communication (written and oral) skills
• Comprehensive knowledge of U.S. medical device regulations, Good Clinical Practice standards, Good Laboratory Practice regulations, and Quality System Regulation
• Current knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC and IVD directive IVDMDD 98/79/EC
• Experience with global CMC regulatory documents (annual reports, supplements, responses and IND/CTAs) and with registration dossiers for worldwide use, with a focus on biologic submissions
• Maintain current knowledge of current and proposed regulations, laws, guidelines standards, and initiatives impacting BSH devices
• Government and regulatory affairs experience strongly preferred
• Strong interpersonal, communication and networking skills, with a high level of personal initiative

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

In the previous role, I was responsible for regulatory labeling (User manuals, instructions for use, labels, etc.) guidance, review and approval for assigned products taking into account regulations, standards and cleared/approved product claims.

Please consider my experience and qualifications for this position:

• Curiosity and passion for new manufacturing technologies
• A passion for product development and the patients who we serve
• Experience with global CMC regulatory documents (annual reports, supplements, responses and IND/CTAs) and with registration dossiers for worldwide use
• Knowledge of FDA, EMA and/or ICH guidelines
• Broad understanding of drug development phases and/or lifecycle management
• Experience in developing global CMC regulatory strategy
• Experience in managing post approval Regulatory CMC activities globally
• Able to plan/prioritize work of group members and guide/develop others

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

In my previous role, I was responsible for operational support for labeling development, management and review for specific products with oversight of Global Labeling Lead.

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

• Excellent grammar and communication skills, both written and oral
• Prior experience as the SME or primary author for CMC sections in support of regulatory filings
• Demonstrated knowledge of US and ICH biologic regulations related to CMC and biopharmaceutical product development
• Understanding of API and drug product manufacture
• Strong knowledge of current Good Manufacturing Practices (cGMP)
• Strong computer skills including MS Word, Excel, PowerPoint, MS Project and Adobe Acrobat
• Strong organizational skills in order to maintain a high level of communication, productivity, innovation, and priority-setting in order to work effectively in a dynamic environment to meet aggressive timelines
• Detail oriented with excellent oral and written communication skills, including scientific writing experience for effectively interfacing with all levels of management and departments within the company

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

Previously, I was responsible for cMC support and advice for all internal activities related to manufacturing, development, control, and quality of commercial and clinical products.

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:

• Strong internal and external networks preferred
• Good knowledge of the current regulation in Russia and CIS and upcoming EEU regulation
• Knowledge of EU and US regulation as an advantage
• Expertise in general business processes execution
• Experience in shaping environment initiatives
• Fluent English& Russian00001B45
• Knowledge of regulatory intelligence program management
• Experience auditing in the pharmaceutical or medical device field