Regulatory Affairs Associate Resume
Headline : A pharmaceutical regulatory professional with experience extending from drug discovery to late-phase development Familiar with Strong experience, knowledge and leadership skills in Project management Regulatory strategies and filings Process optimization New product development CRO outsourcing Risk management Budget.
Skills : Microsoft Office, Ms. Word, MS Office, Outlook, Office: Word, Powerpoint, Photoshop, Photography, Sales, Typing, Windows.
Description :
- Review, publish, compile and QC all sections of aggregate reports such as global regulatory submissions.
- Manage and control all submission dossiers and related documents in accordance with and regulatory guidelines.
- Develop and maintain SOPs as required to assure consistency and compliance.
- Support regulatory affairs activities in the emerging markets, including, operation perspective.
- Evaluate systems and tools that are needed for the regulatory operation group and other related functional groups.
- Perform special tasks as assigned, such as importation of our drugs for a quality test.
- Acts as an essential communications connection for the Regulatory Affairs managing expenses and travel for Regulatory Affairs.
Experience
5-7 Years
Level
Executive
Education
Diploma
Regulatory Affairs Associate l Resume
Headline : To secure a Regulatory Affairs Associate position that leverages experience in regulatory affairs; and educational background in pharmacy, regulatory affairs, and health policy.
Skills : Regulatory affairs, Scientific research, Ms. Word, Ms. Office, Outlook, Office: Word.
Description :
- Participated in the clinical and regulatory strategy team meeting to determine the clinical development programs including bioavailability studies
- Upload finalized documents into the eCTD submission manager to create a final submission copy.
- Compile and review quality agreements and vendor qualification for vendors.
- Interact with the Company's various business units in order to obtain the documentation required for submissions.
- Review technical documents required for submissions and ensure compliance with applicable regulations and guidance.
- Evaluate changes to regulatory documents via the change control process and formulates strategies to maintain submission goals.
- Review and approve stability matrixing and bracketing, protocol, and negotiate and exchange information with all levels of management.
Experience
5-7 Years
Level
Management
Education
MS
Regulatory Affairs Associate lll Resume
Summary : A competent scientist with research and regulatory affairs experience as well as the ability to support a complex matrix organizational environment. Scientific experience includes determining the mechanism of action, developing assays, preparation of scientific manuscripts and presentations at meetings.
Skills : Project Management, Research, and development, Ms. Word, MS Office, Outlook, Office: Word, Powerpoint, Photoshop.
Description :
- Prepared regulatory submissions including authoring, reviewing, which were in accordance with FDA Regulations.
- Responsible for the authoring of annual reports, periodicals and annual reports with minimal supervision in accordance with regulations.
- Trained other associates on paper submissions to condense content to regulation for electronic submissions.
- Ensured that hard copy documents are appropriately rendered into guidance for electronic submissions.
- Provided In-depth knowledge and experience with Adobe Acrobat, MS Word.
- Managing electronic regulatory media and preparing electronic submissions.
- Coordinate apostille legalization of documents and Projects as assigned.
Experience
7-10 Years
Level
Management
Education
Diploma
Asst. Regulatory Affairs Associate Resume
Headline : A competent scientist with research and regulatory affairs experience as well as the ability to support a complex matrix organizational environment. Scientific experience includes determining the mechanism of action, developing assays, preparation of scientific and project management of regulatory submission.
Skills : Regulatory Affairs, Scientific Research, Ms. Word, MS Office, Outlook, Office: Word, Powerpoint, Photoshop.
Description :
- Initiated and assisted regulatory and clinical team members with the study as well as interacting with CROs.
- Created and maintained Global Regulatory Tracker for tracking Health Authority submissions and approvals.
- Authored SOPs as well as Work Procedures for the various regulatory pack, Requesting Formal meetings with FDA.
- Conducted a regulatory review of New Investigator documents as part of site start-up activities for an ongoing clinical trial.
- Prepared and submitted amendments to prepared and submitted new investigator documents.
- Streamlined the submission process by crafting standardized templates and documentation requirements.
- Updated the standard operating procedures regarding documentation.
Experience
5-7 Years
Level
Management
Education
Diploma
Regulatory Affairs Associate ll Resume
Headline : Responsible for on-time filing of high-quality regulatory submissions interacts with regulatory agencies and project teams in relation to submissions to ensure that all requirements are met. Experienced in monitoring payroll expenses. Constantly working to improve the quality of the staff with tips.
Skills : Microsoft Office, Microsoft Office, Open Office, Google Docs, Constant Contact, Crystal Reports.
Description :
- Interacts with regulatory agencies, project teams Plant Corporate documentation to ensure and regulatory compliance.
- Training other team members in the annual reporting/amendment process and other areas as needed.
- Compile, summarize, review, edit and proofread regulatory documentation for Annual reports.
- Monitor and submit applicable reports to regulatory authorities, follow up on issues to avoid delay impact.
- Review and update of labeling, and other departmental documents Qualifications.
- Works collaboratively in a team environment to improve processes; while maintaining awareness of ensuring high-quality assurance.
- Effectively and accurately, assesses, collects, analyzes and reports data while paying close attention to all details.
Experience
5-7 Years
Level
Executive
Education
Diploma
Regulatory Affairs Associate/Consultant Resume
Headline : Regulatory Affairs Associate is responsible for the business development, regulatory compliance and regulatory affairs activities of a company's legal department. Investigating potential regulatory issues, such as product safety or health related issues.
Skills : Physiology, drug delivery, modeling, orthopedics, Ms. Word, MS Office, Outlook, Office: Word, Powerpoint, Photoshop.
Description :
- Maintain and manage complaint records, and other complaint handling documents.
- Coordinate and maintain the Corrective Action Preventive Action Process as required and tracked verification of effectiveness.
- Perform gap analysis on Vigilance and Medical Device Reporting Standard procedures.
- Maintained Medical Device registration and license renewal.
- Participated in annual quality system audits, both internal and external, third-party representatives and consultants.
- Prepared technical documentation for regulatory submissions.
- Assist in Regulatory and submissions Compile and complete the within the regulatory guidelines and timelines.
Experience
5-7 Years
Level
Junior
Education
BS
Regulatory Affairs Associate/Supervisor Resume
Headline : During working on a research project, able to develop a migration assay platform for which applied for intellectual property. Installed them to make a functioning final product giving experience with design, fabrication, and installation.
Skills : Microsoft Office, Ms. Word, MS Office, Outlook, Office: Word, Powerpoint, Photoshop.
Description :
- Identify and interpret regulations, guidelines, and other pertinent other regulatory organizations.
- Review protocols, consent forms, reports, scientific documents, research projects to ensure compliance with regulations.
- Ensure the compilation and maintenance of pertinent documentation required for regulatory compliance for assigned clinical research projects.
- Serve as a member of groups, teams, or committees related to regulatory affairs.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Review clinical protocols to ensure the collection of data needed for regulatory submissions.
Experience
5-7 Years
Level
Executive
Education
BS
Regulatory Affairs Associate/Specialist Resume
Headline : Medical device professional seeking a regulatory affairs position. The industry with wide-ranging project assignments. Experience excelling in high pressure and fast paced environment. Exceptional communication skills.
Skills : Microsoft Office, Ms. Word, MS Office, Outlook, Office: Word, Powerpoint, Photoshop.
Description :
- Coordinate all level drug change controls with impact in multiple countries.
- Collaborate and effectively communicate with global change owners and other functions.
- Tracked ongoing IND protocols and information amendments for various sponsor projects.
- Informed representatives from member companies of regulatory changes, and developed educational programs.
- Created an interactive PowerPoint presentation to assist members in complying with laboratory compliance regulations.
- Review clinical protocols to ensure the collection of data needed for regulatory submissions.
- Coordinate recall or market withdrawal activities as necessary.
Experience
5-7 Years
Level
Management
Education
BS
Regulatory Affairs Associate/Coordinator Resume
Objective : Dedicated professional with regulatory departmental positions. High-energy leader pledged to build and motivating dynamic teams as well as cultivating an environment in which staff feels comfortable.
Skills : Technical Skills: ProEngineer/Creo, Solid Edge, C/C++, Assembly, Java, Matlab, Mathematica, Microsoft Office Suite.
Description :
- Conducted regulatory intelligence and research on relevant regulatory and advertisement-promotional activities.
- Supported the quality assurance and quality checking processes of labeling implementation.
- Verified and maintained drug labels and packaging updates.
- Supported the development and implementation of SOPs for the regulation of marketing materials.
- Worked closely with Regulatory Affairs colleagues to support labeling and advertisement-promotional activities.
- Assisted in the development and preparation of IND and NDA regulatory documents.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Experience
2-5 Years
Level
Management
Education
Diploma
Regulatory Affairs Associate/Analyst Resume
Headline : To secure a position within an agency that will benefit from a trained legal professional with excellent administrative, research, and organizational skills. Dedicated and focused professional that has experience working with equipment maintenance and team supervision that management and manufacturing experience.
Skills : Cubes, Microsoft Office, SAP, Label Review, Product Sign-Off, Online Databases.
Description :
- Responsible for reviewing new and revised labeling materials along with marketing materials for accuracy and conformance to dietary supplement regulations.
- Evaluated and tracked the impact of proposed formulation, documentation and raw material changes through the Change Control process.
- Determined the impact of these requested changes on labeling materials.
- Compiled and reviewed supporting documentation for Change Control product labels in corresponding countries.
- Approved color proofs and label releases for print quality and accuracy.
- Edwards system for final proof and color proof labels.
- Researched and evaluated the regulatory status of ingredients for New Product Proposals.
Experience
5-7 Years
Level
Management
Education
MS
Regulatory Affairs Associate/Representative Resume
Headline : Seeking an opportunity to work in a fast paced environment. Like to be a part of administrating employee benefits, employee relations and part of training.Dedicated and focused professional that has experience working with equipment maintenance and team supervision that has management and manufacturing experience.
Skills : MS Word, Excel, PowerPoint, Outlook, GCP, ICH, FDA, HIPAA, IND, NDA.
Description :
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Review clinical protocols to ensure the collection of data needed for regulatory submissions.
- Write or update standard operating procedures, work instructions, or policies.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Experience
5-7 Years
Level
Management
Education
MS
Regulatory Affairs Associate Resume
Headline : Management professional with experience in the Life Sciences industry. Strong understanding of Clinical Research, Regulations of Drugs and Medical Devices. Experienced in managing the Regulatory documents, facing Inspections by appropriate Regulatory authorities, analyzing the complaints and reporting accordingly.
Skills : MS word, Excel, PowerPoint, Outlook, GCP, ICH, FDA, HIPAA, IND, NDA.
Description :
- Provide support for Regulatory processes of the various meat and other food products clearance.
- Oversee quality control of Regulatory documents and submissions.
- Organize meetings with Regulatory agency staff.
- Assist in the preparation of routine reports and Regulatory agency communications.
- Update and maintain paper/electronic document archival systems.
- Prepare legal documents for import/export, registrations, tenders/bids or other purposes.
- Coordinate internal audits and inspections and reported all initial and supplemental for complaint files.
Experience
5-7 Years
Level
Management
Education
MS
