Regulatory Affair Associate Job Summary: We need a regulatory affairs associate with a bachelor’s degree in biochemistry, health science, or biomedical science. The candidate oversees submission projects ranging from simple to somewhat complex, involving numerous cross-functional regulated filing teams Associate Director, Regulatory Affairs Resume Sample Work Experience • Works to assure products remain in compliance • Build Regeneron’s regulatory profile in the EU, and serve as a resource for EU knowledge for the global regulatory and development teams • Build the representation of Regeneron's EU regulatory function to EMA and EU National Estimated Reading Time: 6 mins 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, 5/5()
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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 regulatory affairs associate resume sample 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, regulatory affairs associate resume sample, computer competencies, and attention to details. Most candidates make display of a Bachelor's Degree in a related field in their resumes. Find out what is the best resume for you in our Ultimate Resume Format Guide. 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.
Responded to deficiencies and questions related to DMFs and Annual Report submissions. Served as Lead Administrator of a Regulatory Submission Management System and Repository. Managed a "system-dedicated" mailbox that encompasses regulatory affairs associate resume sample over access accounts and user records to meet internal compliance standards. SharePoint administrator for Regulatory Affairs.
Development and maintenance of all websites under the Regulatory Regulatory affairs associate resume sample organization. Technical and end-user support of the collaboration environment used within Regulatory Affairs. Conduct international market research for pharmaceutical trading worldwide. Reviewed and evaluated labeling for product packaging as per the regulatory requirements.
Maintained regulatory documents and changes controls Change Request from manufacturer sites on spreadsheet to track updates in product specifications and materials. Gather, extrapolate and interpret data to accurately complete regulatory statements, including but not limited to Safety Data Sheets, Specification Sheets, Nutritional Statements, GMO Statements, regulatory affairs associate resume sample.
Executed plans to ensure all trials were conducted in compliance with the study protocol, site procedures, GCP guidelines, and applicable regulatory requirements. Verifies that documentation is complete and meets submission readiness standards.
Regulatory affairs associate resume sample in developing procedures to ensure regulatory compliance with domestic and global requirements. Associate for Consumer Affairs Special Services; handling highly escalated situations such as consumers who have hired legal counsel, filed complaints with attorney generals and other government regulatory agencies, compensation requests and irate individuals.
Assisted the Sr. Director level position in assuring the timely preparation and submission of all regulatory documentation. Personally responsible for the following specific tasks:. Responsible for reviewing Annual reports, ANDAs, Supplements, Certificates of Analysis, Batch records, Labeling- container labels and Patient inserts for accuracy and completeness.
Publish, compile and submit regulatory non-eCTD electronic submissions NeeS and FDA Electronic Submission Gateway ESG submissions, including Investigational New Drug IND and New Drug Application NDA original submissions, amendments, supplements, meeting requests, annual reports and safety reports.
Project lead for development of client's compliance data system used to track regulatory submissions, maintain CMC information, and support regulatory operations and change management for investigational and post-approval products.
Represent Regulatory team on the scientific exchange materials review team and provide guidance on regulatory issue related to scientific exchange. Prepared CMC registration and re-registration dossiers, MAA, and File A for marketed Oncology products.
Ensure product related CMC regulatory filings are prepared and implemented in accordance with global regulatory strategies, regulations and commercialization strategies.
Assist management with coordination and preparation of document packages for regulatory submissions from all areas of company, in support of active and pending New Drug Applications NDAs e. Developed and evaluated prescription drug labeling and promotional literature to ensure compliance with federal regulations, company policies, and industry standards. Resume Examples Compliance Regulatory Affairs Associate Build a Resume Now. Regulatory Affairs Associate Resume Examples Regulatory Affairs Associates work in the healthcare products industry and help releasing new products by conducting government approval processes.
Edit This Resume Rate This Template:. High Quality The best examples from thousands of real-world resumes. Expert Approved Handpicked by regulatory affairs associate resume sample experts based on rigorous standards. Diverse Examples Tailored for various backgrounds and experience levels. Candidate Info 4. Regulatory Affairs Associate Pharmaceutical lab exclusively dedicated to animal health. 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. Candidate Info 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.
Candidate Info 5. 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, regulatory affairs associate resume sample, policies, and process documentation Maintained data gathering and mining efforts for Production, Quality, and other functions. Candidate Info Regulatory Affairs Associate Assisted in preparing clinical trial submissions for various INDs.
Maintained, scanned, and imported documents into regulatory documentum system. Candidate Info 1. Quality and Regulatory Affairs Associate Prepared and maintain SOPs and training records.
Prepared Failure Mode Effect Analysis FMEA sheets and performed risk assessment. Performed Process Development studies, regulatory affairs associate resume sample, CAPA and Root Cause Analysis.
Executed IQ, OQ and PQ protocols for equipment at lab scale. Regulatory Affairs Associate Served as Lead Administrator of a Regulatory Submission Management System and Repository. Provided valuable feedback on system enhancements and processes to lead improvement efforts. Trained global business partners and colleagues on new global Regulatory Submission Management Regulatory affairs associate resume sample 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 NDAregulatory affairs associate resume sample, Investigational New Drug Applications INDconsumer and professional advertising to meet FDA compliance deadlines, regulatory affairs associate resume sample. 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.
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 regulatory affairs associate resume sample 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. 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. Candidate Info 8. Regulatory affairs associate resume sample 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.
India, Regulatory Affairs Associate Intern Reviewed and evaluated labeling for product packaging as per the regulatory requirements Proofread container and cartons labels, patient leaflets and medication guides Evaluated submission packages of APIs for their accuracy and regulatory compliance Documented Annual Report submissions.
Candidate Info 3. Regulatory Affairs Associate Prepared new and existing ANDA submissions. Imported PI and Labels in Daily Med regulatory affairs associate resume sample HL7 A4L SPL system. Performed compliance check on documentation for electronic submission.
Managed all aspects of regulatory process including annual reports and amendments. Submitted six Initial INDs for the treatment of chronic lymphocytic leukemia CLLSchizophrenia, Autism Spectrum Disorder and Acute myelogenous leukemia AMLMultiple Sclerosis and Alzheimer Disease. Recognized with certificate of excellence by global regulatory head Certified in InSight Publisher Created various submission process improvement projects Transitioned numerous paper submissions in eCTD format.
Regulatory Affairs Associate II Maintained regulatory documents and changes controls Change Request from manufacturer sites on spreadsheet to track updates in product specifications and materials. Reviewed data from Trackwise, regulatory affairs associate resume sample, GxPharma and Oracle databases and converted information in eCTD format to send electronic submission to the FDA.
Complied and submitted the following regulatory documents in eCTD format to the FDA: CBE drug substance and drug product method updates; CBE-0 changes to packaging configurations, CBE-0 updates to Master Batch Records, Minor and Telephone Amendments in response to FDA questions.
Managed annual report documents from international manufacturer sites for inclusion in Commercial Product Annual Reports. Reviewed Safety Alert Reports, Field Alerts, Deviation Reports and Stability Reports regulatory affairs associate resume sample by the Quality Assurance department for legal compliance.
R Supplement Filing prepared and complied the PAS for Alternative source of API Received Industrial Training at [company name]. Assisted to perform quantitative and qualitative analyses of raw material, in process products and finished products following standard operating procedures, using various analytical instrument such as high performance liquid chromatography, gas chromatography, analytical balances, infrared instruments, dissolution testing apparatus.
Assisted in calibration of lab instruments and evaluation of test results for accuracy. Performed standardization of solutions and various instruments as required and recorded results in official logs. In-depth knowledge regarding production of solid and liquid dosage form in compliance cGMP regulatory affairs associate resume sample. Regulatory Affairs Associate Gather, extrapolate and interpret data to accurately complete regulatory statements, including but not limited to Safety Data Sheets, Specification Sheets, Nutritional Statements, GMO Statements.
Evaluate flavor and fragrance formulations for compliance to a host of regulations and guidelines. Manage information on raw materials to guarantee current and precise data.
How to get a job in Regulatory Affairs
, time: 10:27Regulatory Affairs Associate Resume Samples | QwikResume
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, 5/5() Regulatory Affairs Associate Resume Example • Excellent working knowledge and advanced experience with FDA/ICH guidances for INDs, sNDS, NDAs, ANDAs, BLAs and major • Collaborative knowledge of eCTD publishing, IND, NDA, IND-NDA annual reports, NDA/ BLA cover sheet, eCTD filing and • Regulatory Affair Associate Job Summary: We need a regulatory affairs associate with a bachelor’s degree in biochemistry, health science, or biomedical science. The candidate oversees submission projects ranging from simple to somewhat complex, involving numerous cross-functional regulated filing teams
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