Regulatory Affairs Specialist Resume Samples

Description :

1. Represented the EHS department at SAP integration project design and requirement analysis at Accenture consulting campus.
2. Developed training manuals for North American employees to support SAP integration and deployment.
3. Managed a team of five employees for the successful deployment of software systems for chemical substance registrations.
4. Completed user acceptance testing for deployment of SAP EHSM in conjunction with international colleagues.
5. Developed product label and SDS templates for GHS, REACH and CLP requirements.
6. Updated the work instructions for documentation related to submissions to international regulatory agencies, revised a technical file.
7. Prepared and submitted product annual reports to the Food and Drug Administration Created an annual budget for management.

Experience

5-7 Years

Level

Executive

Education

BS

Description :

1. Worked within the framework of a team to perform premarket and post-market activities, providing support throughout the total product lifecycle.
2. Handled complaints, gather required information, medical device reporting, CER's, analysis and review, submission of reportable events.
3. Managed timelines, and handled domestic and international product registration, including renewals.
4. Managed the entire UDI Implementation process for the company, ensuring all Class I, II, and III devices were UDI compliant by their respective deadlines.
5. Assisted in the determination of appropriate safety, regulatory, evaluation, and testing requirements.
6. Performed Gap Analyses, analyzing standards, guidance documents, technical reports, and regulations.
7. Worked on interdisciplinary teams during new device development, design and label/IFU changes, providing feedback on the regulatory status.

Experience

2-5 Years

Level

Executive

Education

Bio engineering

Description :

1. Prepared and project managed to cross functional teams to support FDA submissions: PMA, PMA-S, Real-time review, Clinical updates.
2. Developed RA strategy, authored and obtained 30-day approval for a change to the primary packaging for the Xcelerant Delivery System.
3. Obtained approval for the addition of a hydrophilic coating to the Xcelerant Delivery System for the AneuRx and Talent Thoracic Delivery system.
4. Developed, reviewed and updated product labeling and claims to meet global regulatory compliance.
5. Identified and problem solved the first article of inspection for translated documents, lead to the implementation of Extensible Markup Language.
6. Developed and implemented a Labeling strategy to meet the GS1 barcode standard to meet EU requirements.
7. Prepare and maintain regulatory compliance to FDA and international regulations and support pre and post-market activities.

Experience

5-7 Years

Level

Executive

Education

Masters

Description :

1. Invited speaker for Pharmaceutical and Healthcare conference held at Chennai.
2. Research and Teaching Skills Design of Experiments (DOE): Expertise in the use of role of statistics in design of clinical trials.
3. Experienced in research techniques used in formulating drugs, data modeling, and optimization process.
4. Good understanding of statistical packages such as statistical packages 'Stat graphics 5.0' and 'Sigma Stat' for fitting experimental data.
5. Conducting passive transdermal studies using both in vitro & in vivo electrically assisted drug delivery techniques - iontophoresis and electroporation.
6. Experience in tablet, capsule and liquid drug formulation by effective usage of drug microencapsulation drug delivery.
7. Expertise in the development of analytical methods using HPLC for pediatric formulations, direct injection HPLC methods.

Experience

10+ Years

Level

Management

Education

Biologic

Description :

1. Provided support for departmental Regulatory Affairs activities to ensure compliance with local, regional, and corporate regulatory requirements.
2. Created new licenses based on product approval; researched and released all blocked orders Ensured timely input to regulatory measures.
3. Provided responses to routine requests for information or documentation for new or existing product support.
4. Teamed up with other RA Specialists to provide regulatory support for changes to existing products and new products.
5. Activities include working with Specialists and other cross-functional team associates to develop regulatory plans and deliverables list for product changes.
6. Reviewing documents required for submissions to ensure they are appropriate for submissions.
7. Maintained RA product files to support compliance with regulatory requirements. Provided regulatory support for currently marketed products as necessary.

Experience

5-7 Years

Level

Executive

Education

Management

Description :

1. Drafted informed consent documentation for ongoing clinical research trials in the US Oncology Research network.
2. Obtained institutional review board (IRB) approvals for start-up, renewal, and closeout of clinical research protocols.
3. Maintained clinical trial master files in paper/electronic formats for FDA and study sponsor auditing.
4. Cleared all study-related adverse events, advertising materials, consent forms, and other items for approval.
5. A notified review board of trial changes, enrollment status, and protocol deviations.
6. Translated clinical protocol schema into lay terms and drafted study-specific patient informed consent documents.
7. Coordinated trans-departmental review of patient informed consent forms for accuracy, consistency, and adherence to study protocol.
8. Managed process for study modifications by examining sponsor correspondence to identify changes.

Experience

2-5 Years

Level

Junior

Education

Bachelor Of Arts

Description :

1. Created a database for engineering staff to maintain up to date regulatory documentation for research and development applications.
2. Conduct internal audits and detailed reports for quality, regulatory, facility and health and safety.
3. Obtain and distribute updated information regarding domestic or international laws, guidelines or standards.
4. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
5. Edited new marketing catalog for regulations, patent-pending products and for grammar and format.
6. Assisted the Director and team in preparation for trade shows in research for products, sales distribution and event planning.
7. Maintain current knowledge base of existing and emerging regulations, standards, or guidance on documents.

Experience

2-5 Years

Level

Junior

Education

Masters

Description :

1. Prepares and submits international product registration documentation for various classes of medical devices.
2. Modifies a Summary of Technical Documentation (STED) per the request of the country to be registered.
3. Maintains system/procedures for developing and updating registration documentation in support of internationally marketed products.
4. Initiates spreadsheet with product identification of FDA, GMDN, HSA codes for global registration.
5. Maintains status registration of each country per distributor or representative agent of each product line.
6. Participates in external quality system audits conducted by FDA, FDB, notified body representatives (MDD), other regulatory agencies.
7. Prepare and update the US and International product listings, registrations, certificates, and licenses.

Experience

7-10 Years

Level

Management

Education

General Education

Description :

1. Responsible for providing worldwide pre-market and post-market regulatory affairs support for Class II and Class III medical devices.
2. Coordinate and prepare document packages for regulatory submission including 510(k), Investigational Device Exemptions.
3. Compile materials required worldwide Pre-market and Post Market regulatory affairs submissions, License renewals and annual registrations.
4. Ensuring regulatory compliance through the design process for new products; conducting regulatory assessments for product changes.
5. Monitor and improve tracking and control systems and recommend strategies for the earliest possible approvals of clinical trial applications.
6. Review labeling and advertising material to meet the regulatory requirements of the domestic and international markets.
7. Review the Design History File and Engineering Change Request to ensure design control processes related to product release.

Experience

10+ Years

Level

Senior

Education

MS

Description :

1. Responsible for the interpretation, direction, determination, and reporting of regulatory agency requirements.
2. Perform new product registrations with appropriate regulatory agencies around the world.
3. Complete cosmetic notifications for new products or for amendments made to the formulation of an existing product.
4. Ensure that all products are in compliance with each country's registration or listing requirements prior to product marketing.
5. Analyze and evaluate existing SOPs and record-keeping systems and create new procedures and processes.
6. Serve as an audit/inspection escort during audits by interacting with other escorts and department managers.
7. Provide expert advice to management to ensure product claims and marketing materials are in compliance with local and international regulations.

Experience

5-7 Years

Level

Executive

Education

Biologics

Description :

1. Maintained country and individual restrictions based on OFAC, BIS, and the other U.S.
2. Partnered with IS to develop internal software, Training tool, SAP interfaces, ECN process improvements, and creation of the ICN process.
3. Created and trained staff on various policies, procedures and work instructions, including the Corporate Code.
4. Creates and conducts onsite and distance training on various standards as well as internal policies and procedures.
5. Researched and applied for a state grant to obtain training funds.
6. Oversaw the scheduling of the training schedules to ensure training and grant requirements were met.
7. Acquired responsibility for the coordination of the material master data management process and procedures.

Experience

10+ Years

Level

Senior

Education

Masters

Description :

1. Supported company operations by acting as the general regulatory resource for the company.
2. Research and rendered advice/opinions on regulatory matters, including regulatory evaluation of proposed changes to the facilities.
3. Supported customer filings for marketing authorizations by generating portions of new drug applications.
4. Generated position papers for OsoBio facility modifications, media files, etc.
5. Participated in the change control process through a regulatory review of proposed changes.
6. Filed applications for state, local, national, and foreign licenses, permits, registrations, etc., as required to keep the facility in compliance.
7. Developed a controlled substance program for Osorio, with a particular focus on regulatory compliance.

Experience

10+ Years

Level

Senior

Education

Juris Doctorate