Regulatory Affairs Associate Cover Letter

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

In my previous role, I was responsible for guidance to project teams to ensure compliance with applicable FDA regulations and guidelines.

Please consider my experience and qualifications for this position:

• Possess interpersonal and organizational savvy
• Understanding of the pharmaceutical industry, clinical trial processes, and GxP
• Able to deal effectively with all levels of the organization
• Self-starting with outstanding work ethic
• Aptitude for eCOA, electronic source data, data handling, and data privacy principles
• Fluency in English along with the local language
• Previous experience in Regulatory Affairs and Clinical Research Experience in clinical study start-up
• He/She has worked already in an international environment or CRO

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

In the previous role, I was responsible for assistance and support to Principal Investigators, for timely and accurate submissions of annual reports or other regulatory documents required by the FDA.

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:

• IND Amendments and Annual Reports
• Provide CMC Regulatory support as needed for the authoring/co-authoring/review of documents related to all OTC drugs marketed in the US under the FDA Monographs
• Attend meetings for assigned projects, as needed, to provide Regulatory perspective/oversight and ensure products are developed and manufactured in accordance with cGMP and all applicable US regulations
• Collaborate with R&D and other cross-functional partners to support compliant execution of change management via the review of CMC-related change documentation
• Assess and communicate potential CMC Regulatory risks to products and/or projects and propose mitigation strategies
• Deliver all CMC Regulatory milestones for assigned products across the product lifecycle
• Identify, communicate and escalate potential CMC Regulatory issues to Regulatory Management, as needed
• Monitor the US Regulatory environment, gather any CMC-related technical information and work with the CMC Regulatory Manager/US Regulatory client procedures

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

Previously, I was responsible for promotional regulatory strategy and prepares submissions for advisory comments by FDA and negotiates directly with FDA any changes requested.

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

• Experience with cardiovascular devices and knowledge of QSR and ISO-13485 system requirements
• Clinical knowledge of medical devices
• Supervise preparation of marketing authorisation applications for pharmaceutical (ethical and OTC) products
• Ensure that these marketing applications are in compliance with Australian/ New Zealand requirements, and submitted in compliance with Sandoz Submission Plan and consistent with the company's strategic goals for marketing, manufacturing, and selling
• Development, implementation and maintenance of SOPs in support of regulatory functions as needed and implement clearly defined regulatory processes
• Supervise maintenance of current product portfolio
• Transfer of manufacturing processes
• Ensure compliance of regulatory personnel with Global Working Instructions

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

In my previous role, I was responsible for proactive promotional strategies and tactics in alignment with FDA regulations and guidance documents so the company can meet both short and long term growth targets.

Please consider my experience and qualifications for this position:

• Thorough knowledge of the drug development process, IND and NDA process
• Works on complex problems in which analysis of situations or data requires and in-depth evaluation of various factors
• Attend trade association/Regulatory Agency meetings and represent clients’ interests with key government agencies while remaining competitive
• Apply Microsoft Office programs and clients’ Systems relevant to area of responsibility to deliver against project strategy
• Familiarity with regulatory (FDA, EMA, Health Canada and ICH) guidelines
• Regulatory experience in markets outside the US is highly desirable
• Knowledge of local regulations and experience in registration matters
• Good interpersonal, presentation and effective communication skills

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

In my previous role, I was responsible for assistance and support to Principal Investigators, for timely and accurate submissions of annual reports, IND Safety Reports, Response to FDA Request for Information, or other regulatory documents required by the FDA.

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:

• Experience in/knowledge of developing and maintaining CTA documentation in the EU
• Understanding of the Global and regional pharmaceutical market place and familiarity with medical terminology
• Working knowledge of MS Access, MS Project, MS InfoPath and Adobe Acrobat Pro
• Experience working with MSDS's, labels, Life Cycle Management
• Demonstrated success in project management / coordination
• Experience with MSDS software
• Strong working knowledge of US CMC regulations and guidelines applicable to OTC drugs including NDA and IND compilation and filing requirements
• Knowledge of FDA, EU, MHLW, Canada and TGA requirements (helpful)