Regulatory Affairs Cover Letter Examples

Regulatory Affairs Associate Resume Samples

Regulatory Affairs Associates work in the healthcare products industry and help releasing new products by conducting government approval processes. Common work activities listed on a Regulatory Affairs Associate resume sample are ensuring compliance with industry regulations, collecting scientific data, handling license submissions, updating legislation knowledge, and supporting teams developing new products. Key qualifications for this role are regulatory legislation expertise, good communication abilities, networking, computer competencies, and attention to details. Most candidates make display of a Bachelor's Degree in a related field in their resumes.

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1

Regulatory Affairs Associate

Pharmaceutical lab exclusively dedicated to animal health. Develops, produces and distributes drugs and vaccines for the prevention and treatment of the pathologies in companion and food producing animals.

  • Coordinated and followed up on regulatory actions.
  • Collaborated with internal working groups for packaging creation of newly acquired products; reviewed and validated product information in packaging, instructions for use, and labels.
  • Addressed and responded to questions from regulatory agencies.
  • Prepared applications for variations to regulatory agencies.
2

Regulatory Affairs Associate

Responded to deficiencies and questions related to DMFs and Annual Report submissions.

  • Coordinated with other team members for developing and implementation of the SOP
  • Examine and compile the Labeling, Advertising and Promotional materials with Regulatory Compliance
  • Reviewed and approved quality system documents to determine compliance with regulatory regulations and standards
3

Regulatory Affairs Associate

  • Designated as a Lead Quality Auditor for internal audits system
  • Administered and configured SAP and MasterControl business solutions
  • Assisted Regulatory and Quality departments in maintaining QMS
  • Developed SOPs, policies, and process documentation
  • Maintained data gathering and mining efforts for Production, Quality, and other functions
4

Regulatory Affairs Associate

Assisted in preparing clinical trial submissions for various INDs.

  • Maintained up-to-date knowledge of data requirements and formats, applicable current SOPs,
  • Reviewed revised product labeling information, package inserts, and container/packaging
  • Identified and composed draft correspondence relevant to projects as assigned, such as letters of response, transmittal and memoranda where applicable.
  • Maintained, scanned, and imported documents into regulatory documentum system.
5

Quality and Regulatory Affairs Associate

Prepared and maintain SOPs and training records.

  • Performed Design of Experiment, Process Capability Study, Accuracy and Precision, Statistical Process Control and Gage R&R for optimization of various process parameters using Minitab16 statistical software.
  • Prepared Failure Mode Effect Analysis (FMEA) sheets and performed risk assessment.
  • Performed Process Development studies, CAPA and Root Cause Analysis.
  • Authored Validation Master Plan, Process/Cleaning Validation Protocols, Equipment Qualification Protocols and Validation Summary Reports.
  • Executed IQ, OQ and PQ protocols for equipment at lab scale.
6

Regulatory Affairs Associate

Served as Lead Administrator of a Regulatory Submission Management System and Repository.
Managed a "system-dedicated" mailbox that encompasses processing over 1500 access accounts and user records to meet internal compliance standards.

  • Provided valuable feedback on system enhancements and processes to lead improvement efforts.
  • Trained 170 global business partners and colleagues on new global Regulatory Submission Management System and Repository to ensure team's compliance to corporate policies.
  • Assisted Regulatory liaisons with the preparation, publishing and electronic filing of Regulatory submissions such as New Drug Applications (NDA), Investigational New Drug Applications (IND), consumer and professional advertising to meet FDA compliance deadlines.
  • Oversaw system support help desk to ensure user ticket issues are resolved in a timely fashion and comply with the company's Service Level Agreement (SLA).
7

Regulatory Affairs Associate

  • Implemented the first corporate regulatory eCTD submission software system and subsequent upgrades,
  • Trained all Regulatory Affairs personnel on the use of eCTD software, electronic publishing, use of the [company name] gateway, and SPL conversions,
  • Represented Regulatory Affairs on other corporate GMP software implementation teams,
  • Supervised the conversion of legacy paper files to electronic files,
  • Prepared and submitted Original Submissions, Amendments, Periodic Adverse Drug Experience Reports, Annual Reports, Supplements, SPL/Drug Listings, and Establishment Registrations.
8

Regulatory Affairs Associate

Provided submission development support to project teams and the regulatory community with product/projects assigned to RA Ops submission staff across divisions based on business need.

  • Supported the compilation, development, publishing, submission and maintenance of regulatory filings under the direction of RA Ops submission manager and Regulatory Affairs associates. Thorough knowledge of regulatory filing, of IND, NDA, ANDA, BLA.
  • Managed the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using Electronic Document Management System, to ensure that said documents meet requirements for Submission.
  • Liaison with local internal departments and Corporate RA and QA to obtain documentation required for registrations or other regulatory submissions. Supported on major applications in an effort to support submission timelines and Completion of assigned tasks with a high level of quality within company timelines.
  • Became Aware of ICH and FDA regulations and guidance as we applied to electronic submissions and also became Familiar with content and organization of regulatory submissions. Followed company standard operating procedures and policies.
  • Assisted in maintenance of product information and planning milestones for global regulatory activities. Prepared and published of regulatory submissions including preparation, QC, tracking and archiving.
  • Supported the compilation of submission outlines and assembly of submissions assuring accurate recordkeeping and documentation preparation. Assisted in all areas of responsibility, including interpreting and enforcing paper and electronic regulatory submission standards, policies and operating procedure requirements.
9

Senior Regulatory Affairs Associate / Sharepoint and Records Management

SharePoint administrator for Regulatory Affairs. Development and maintenance of all websites under the Regulatory Affairs organization. Technical and end-user support of the collaboration environment used within Regulatory Affairs.

  • Provided first-line support of the eRoom collaboration environment, reviewed all new eRoom requests, created new eRooms when approved, and worked with IT to create external eRooms.
  • Developed and maintained all Regulatory Affairs intranet websites using IBM WebSphere and Web Content Management software.
  • Worked closely with IT to migrate the collaboration environment (eRoom) and websites (WebSphere) to the SharePoint platform, ensuring all migrations were successful and end-users were supported.
10

Pharmaceutical Regulatory Affairs Associate

Conduct international market research for pharmaceutical trading worldwide

  • Set a regulatory strategy for international trading of surgical equipment, insulin, and syringes
  • Performed initial physical assessment on patients in eye clinic
  • Completed rigorous training in mechanism, presentation, triage, and management of common overdoses and toxins
  • Received and managed calls with attention to emotional state and education level of caller

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Sample cover letter for Internship position at Novartis

POSITION:

Doctoral candidate

Dear Sirs

My name is ____, I´m a M.Sc. in Bioengineering currently at the final stages of my doctoral studies in the doctoral clinical research programme from -----------. The opportunity to be part of an internship program at Novartis is a tremendous opportunity to learn from the best.

Below are examples of my background experience as a graduate and postgradute student:

As an Bioengineer during my studies I´ve significantly dealt with several data collection and analysis e.g. Bioreaction engineering processes, biomechanical data and others (all heavily based in data collection and analysis). I´m familiar with program language MATLAB and visual software program LABVIEW.

As a doctoral student studying the innate immune mechanisms during Osteoarthritis I´ve used data collection and analysis in several different ways:

-patient data collections samples and epidemiological data

-functional data from functional studies which required significant data collection and calculation: gene expression analysis (only in Excel, I´ve never used the available commercial software), immunoassays, Statistical analysis etc.

-Proteomic analysis (high throughput data from mass spectrometry analysis) which required extensive data mining in order to decipher newly identified proteins, while at the same time to identify relevant biological pathways by cross referencing with the huge data-bases available to the scientific community.

From the list of examples which I´ve worked with, you can clearly see I do have considerable experience dealing with scientific research in a very translational way. I therefore feel I could have the necessary scientific skills and knowledge to bring valuable input into Regulatory affairs of drug development.

I look forward to hearing back from you soon

Thank you very much for your attention

Best regards



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