Regulatory Specialist Cover Letter

Regulatory Specialist Cover Letter

4.9
154 votes for Regulatory Specialist

15 Regulatory Specialist cover letter templates

What to include in a Cover Letter
1
Company Address
2
Salutation
3
Compelling Details
4
Respectful Closing

How to Write the Regulatory Specialist Cover Letter

4165 Chase Locks
Ezekielfurt, TN 75469
Dear Shae Wunsch,

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

In my previous role, I was responsible for secondary regulatory review and approval of digital and promotional materials submitted for the Docket Approval Process(DAP).

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

  • Excellent communication skills written and verbal and experience in dealing with government agencies at all levels
  • Knowledge of Broker-Dealer Regulatory rules and interpretations (15c3-1/3 and CFTC and FCM)
  • Experience of providing regulatory strategies to multidisciplinary teams
  • Project management and technical writing skills including experience in regulatory submissions
  • A hybrid of capabilities including understanding of scientific and regulatory aspects in a commercial model
  • Experience in Quality Assurance and Regulatory Affairs in FDA based Pharmaceutical manufacturing
  • Experience in managing complex projects with multiple tasks and shifting priorities
  • Effectively influence affiliates, regulatory agencies and manufacturing contractors

Thank you in advance for reviewing my candidacy for this position.

Sincerely,

Shiloh Langosh

Responsibilities for Regulatory Specialist Cover Letter

Regulatory specialist responsible for regulatory support for the timely submission of new drug applications, variations and clinical trial applications, in accordance with local regulatory requirements.

Support and timely submission/approval of best in class regulatory documentation (including product submissions/re-registrations, novel ingredient applications, additive petitions, claims petitions and deficiency responses)
Advise on Codes, Regulations, Laws, and provide timely and up to date information on current & emerging regulations in order to widen and increase knowledge of the regulatory environment for the business
Review and approval of promotional material ensuring compliance with all relevant codes and regulations
Develop and maintain positive relationship with stakeholders either internal or external including key opinion leaders and key influencers in regulatory bodies & industry associations
Support senior leadership on interactions with trade associations
Regulatory experience within the food or pharmaceutical industry
Knowledge of FSANZ Food Standards Code and Australian / New Zealand Food Acts highly regarded
Experience in dealing with Devices, Regulatory bodies like Medsafe, TGA, and other statutory authorities such as the ACCC is considered an advantage

Regulatory Specialist Examples

Example #1

Example of Regulatory Specialist Cover Letter

479 White Mountain
Davishaven, LA 75209
Dear Robin Aufderhar,

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

In my previous role, I was responsible for direction to regulatory affairs staff responsible for the review and approval of promotional materials and labeling for products.

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

  • An innovative frame of mind – open to applying creative techniques to find a solution
  • Execution - persistent drive for results utilising sound project focus, organisational and problem solving skills
  • Comprehensive understanding of biological and chemical WMD safety and security requirements, and experience effectively implementing requirements related to Federal (CFR), State and Army Regulations/laws
  • Extensive knowledge and experience interpreting DoD/DA regulations
  • Knowledge of GLP and AAALAC requirements to support a research facility that specializes in chemical and biocontainment research
  • Hedge Fund accounting and/or regulatory experience
  • Experience assisting with authoring, contributing and/or reviewing technical documents/product documents for new or modified regulated products, and/or has experience creating an assessment of compliance or evaluated the impact to current regulatory status (clearance, registrations, licenses, or approvals) of process or products
  • Understands Quality System Regulation submissions and the documentation needed to support it

Thank you for your time and consideration.

Sincerely,

Denver Sipes

Example #2

Example of Regulatory Specialist Cover Letter

93332 Precious Lakes
Louport, WI 30575
Dear Tyler McKenzie,

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

Previously, I was responsible for regulatory guidance and direction as the senior regulatory affairs project lead, supporting external customers with regulatory projects throughout the product development life-cycle.

Please consider my experience and qualifications for this position:

  • Knowledge of ISO continuous improvement and controlled document methodologies and processes
  • Experience with ITIL-based processes service delivery methodologies
  • Experience with health care and/or federal government regulatory bodies and auditing methods
  • Strong submissions experience
  • Experience in the field of RA desirable
  • Track record of working with authorities, distributors are desirable
  • Competence of managing ambitious timelines
  • Proven to be able to take decisions and remain accountable for their results

Thank you for your time and consideration.

Sincerely,

Brooklyn Raynor

Example #3

Example of Regulatory Specialist Cover Letter

285 Price Land
Eufemiaside, OH 70597
Dear Greer Mosciski,

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

In the previous role, I was responsible for regulatory assistance for tenders and support daily business from regulatory affairs perspective in accordance with Janssen guidelines and local laws & regulations.

Please consider my experience and qualifications for this position:

  • BS in science or engineering program
  • Regulatory and/or quality experience in chemical, medical device and/or pharmaceutical products
  • Work effectively with other team members to solve problems and implement solutions
  • High communication interpersonal skills
  • Support Global Regulatory Managers and Regulatory Chemistry experts by preparing standardized assessments, data summaries, data sheets, dossiers and other documentations which are accurate, complete and consistent with company standards
  • Awareness of product registration requirements and regulatory science issues and preferably
  • Current working knowledge of Microsoft Suite and Windows
  • Draft letters, comments, responses to queries and other communications for submission to the regulator and other relevant ministries regarding telecommunications regulatory issues

Thank you for considering me to become a member of your team.

Sincerely,

Stevie Stracke

Example #4

Example of Regulatory Specialist Cover Letter

147 Nicolas Light
Port Arla, KY 45707-3728
Dear Justice Heidenreich,

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

Previously, I was responsible for strategic regulatory direction on the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments, critical issue management.

Please consider my experience and qualifications for this position:

  • Demonstrates strong writing and communication skills
  • Able to identify risk in Regulatory strategies
  • Excellent use of Microsoft Office applications
  • Knowledge of submission standards in various formats
  • Knowledge of good documentation practices and requirements for managing regulated records
  • Capable of utilizing IT systems supporting regulatory affairs such as document management, electronic publishing, and submission systems (e.g., SharePoint, Documentum, InSight Publisher)
  • Skilled in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project)
  • Excellent written and oral communication skills to effectively observe, question, extract, document, and present information to associates at all levels within the organization

Thank you in advance for reviewing my candidacy for this position.

Sincerely,

Corey Rodriguez

Example #5

Example of Regulatory Specialist Cover Letter

5920 Jacques Common
Chandraview, AR 08296-3598
Dear Sutton Hirthe,

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

In my previous role, I was responsible for regulatory review and approval for domestic and international promotional material review, and regulatory guidance as needed.

Please consider my qualifications and experience:

  • Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards
  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
  • Knowledge of Microsoft Office, excel, power point, Internet
  • Abilities to work in an ever changing environment and changing priorities
  • Flexible, team player, positive attitude and willingness to always learn more
  • Experience with FDA QSR and ISO13485 requirements and experience in FDA and quality system implementation
  • Solid working knowledge of FDA and international medical device regulations
  • Auditor certificate preferred

Thank you in advance for taking the time to read my cover letter and to review my resume.

Sincerely,

River Mueller

Resume Builder

Create a Resume in Minutes with Professional Resume Templates