Regulatory Compliance Specialist Cover Letter

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

In my previous role, I was responsible for quality guidance on GMP regulatory requirements (including 21CFR Parts 50, 54, 56, 58, 210, 211, 312, 314, 812, 820, Part 11, and Annex 13), including training of R&D personnel.

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:

• Keeping update the Regulatory Standard Management
• Guarantee the knowledge of people in Regulatory department based on continues training
• Preparing a monthly report for all regulatory activities, monitor & report all the significant changes in the regulatory environment
• Process renewal for Janssen products & manufacturing sites registered in the GCC
• Process CMC variations & insert leaflet variations received from Global Regulatory Affairs (GRA)
• Maintain an up-to-date database for all submissions in SPS, PKB, SharePoint and TrackWise
• Preparation, proofreading and approval of packaging components (PIL
• Assure Record Management plan for all Regulatory documentation

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

Previously, I was responsible for advice and guidance to employees on the compliance framework which include policies and procedures such as those contained in the Compliance Manual, internal codes of conduct and practice guidelines.

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

• Assist warehouse in the shipment and/or receipt of controlled substances
• Facilitate outside departments with site-specific controlled substance issues
• Knowledge of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC)) format, content, and filing requirements for US and EU
• Knowledge of product Regulatory Standards
• Knowledge of global product regulatory and safety requirements, including European, North American, Chinese, Korean, Australian, and other countries
• Safety and Regulatory Experience
• Educates and mentors employees
• Knows Company goals and sets own SMART SQP goals for each department

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

In my previous role, I was responsible for support for monitored trials in the form of research into regulations and review of protocols and Case report templates for protocol staff.

Please consider my qualifications and experience:

• Excellent computer skills including proficiency with Excel, PowerPoint, & visualization tools (Spotfire, Qlickview, etc)
• In depth knowledge of industry pipeline procedures primarily for transmission systems governed by PHMSA/DOT Part 195 regulations relevant state rules affecting operations
• Regulatory Affairs Certification preferred
• Knowledge of manufacturing practices and the product development process is beneficial
• Excellent verbal, written, multi-tasking and presentation skills
• Exhibits professional behavior appropriate to a food safety auditor, behaving with integrity, honesty, impartiality, and reporting any potential conflicts of interest
• Expert knowledge of regulatory requirements and food laws and their interpretation
• Experience in the execution of Global Food Safety Initiative Certification Schemes (GFSI)

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

In my previous role, I was responsible for expert support and develop and deliver resources and training on changing human research regulations, new and emerging trends and special topics to the investigator and research community, and provide specific expertise to GCP (Good Clinical Practice) trainers for development and maintenance of the CTSA Workforce initiative.

Please consider my qualifications and experience:

• In-depth understanding of regulatory policy that governs the brewing industry
• In-depth knowledge of Quality Systems, HACCP, Food Safety/GMP, FSMA, SQF
• In-depth understanding of Brewing process
• Knowledge of the packaging process
• BS in environmental science, wildlife biology, ecology, wetland science, or related scientific field
• Significant experience in evaluation of impacts coordination with regulatory agencies related to environmental permitting
• Demonstrated applied knowledge of FDA and international medical device regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS)
• Maintain current DEA registrations

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

In my previous role, I was responsible for advice and guidance to management and technical/account teams on their compliance exposures/posture to governing security guidelines, standards and policies.

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:

• Gathers info from various departments, analyzes data, develops plans to improve results and executes
• Creates an annual plan for facility and operational improvements including projects, capital expenditures
• Tactful in dealing with Regulatory Agencies
• Tactful in dealing with sensitive matters
• Able to listen without judging
• Understands he/she is part of an organization and results are achieved by working cooperatively with subordinates, peers and company leaders
• Enforces consequences for undesirable behaviors
• Provides fair and accurate feedback immediately, both positive and negative