Associate, Regulatory Affairs Cover Letter

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

Previously, I was responsible for guidance on the creation of labeling as well as review and approve labeling, promotional and advertising collateral as applicable to ensure compliance to industry standards and regulations.

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

• Experience in regulatory affairs or quality preferred
• Experience evaluating information to determine compliance with standards, laws, and regulations preferred
• Submit eCTD submissions to health authorities and track related information in department databases
• Prepare and submit Periodic Adverse Drug Experience Reports in accordance with current FDA requirements
• Knowledge of the pharmaceutical business and regulations and drug development process is helpful
• Knowledge of GMP/FDA regulations
• Some Knowledge of the Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and the current ISO 13485 and JPAL
• Some skill in the use of ERP systems such as SAP

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

In my previous role, I was responsible for strategic input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, and labeling for drug and diagnostic 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 working knowledge of US CMC regulations and guidelines applicable to OTC drugs including NDA and IND compilation and filing requirements and Monograph products
• Strong working knowledge of current Good Manufacturing Practices (cGMP)
• Proficient in Microsoft Word, PowerPoint, Excel, Access and Project
• Understands related fields (e.g., manufacturing, analytical, quality assurance)
• Understanding of registration and regulatory requirements in Africa Eurasian countrie
• Commanding knowledge of worldwide regulatory procedures, especially for medical devices
• Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales
• Possess computer competency in Microsoft office software, data collection and general analysis tools

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

Previously, I was responsible for regulatory guidance to drug development teams, merging scientific principles and Health Canada law and regulations for new product development.

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

• Provide monthly reports to RCC Holzkirchen about the regulatory activities of the team
• Provision of annual report to RCC Holzkirchen about major changes in regulatory en-vironment in Australia
• Assisting Scientific Affairs Manager in monitoring regulatory expenses
• Tertiary qualification in Science and/or Pharmacy preferred
• Working knowledge of the local drug regulations, clinical trials regulations and relevant ICH guidelines
• Experience in regulatory of clinical trials
• State wholesale and distributor license renewal procedures
• Experience in multiple phases of development in various therapeutic areas

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

Previously, I was responsible for technical guidance and product training to international affiliates RA during strategy formulation, submission preparation and development of labeling.

Please consider my qualifications and experience:

• A Regulatory Affairs Certification (RAC) is preferred
• Excellent project planning, administrative and organizational skills
• Prior interaction with the FDA is preferred
• Understanding of registration and regulatory requirements
• Knowledge/understanding/experience in the following legislations and field would be an added value
• NDA Original Submissions
• NDA Supplements
• NDA Annual Reports

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

In the previous role, I was responsible for guidance to investigators and project teams regarding regulations and pertinent considerations from drug production planning and purchasing through to drug destruction.

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

• International Regulatory Medical Device experienceSearch Jobs US
• Demonstrated experience with U.S. submissions and a working knowledge of FDA/EMA regulations, the regulators, and the approval process
• A record of successful U.S. submissions for biologics and drugs which include INDs, NDAs/BLAs, MAAs, Annual Reports, and Amendments
• Clinical/medical writing
• Regulatory submissions, Module 1 development
• Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations
• Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
• Demonstrated experience with health authority submissions, , authored, reviewed and managed an original/supplemental application (IND, NDA, BLA, MAA, CTA, NDS