Regulatory Associate Resume Samples

A Regulatory Associate is responsible for staying aware of all the regulations relating to the industry they work in and ensure that they are followed. While the type of the organization varies, and regulations vary, the duties carried out are common and are listed on the Regulatory Associate Resume as – reviewing the processes used in the laboratory, establishing guidelines and standards for specific tasks, knowing all the applicable laws and regulations, ensuring the staff members stay aware of the legal standards that are needed at work, investigating the processes in place, and observing staff. Identifying issues and assessing potential solutions, and making recommendations about needed changes are also a part of the job description.

Regulatory Associates should have the ability to pay close attention to detail and be able to thoroughly review processes and data and identify issues. They should use computers to prepare and analyze data, hence good computer skills are needed. Communication skills are also needed as regular interaction with staff members is a daily task for such associates. Strong writing skills to produce technical documents are also crucial. Degree programs in regulatory affairs and compliance, health science, and biomedical regulatory affairs are considered ideal to enter the occupation.

Regulatory Associate Resume example

Regulatory Associate Resume

Summary : Regulatory Associate with over 15 years of industry experience. Experienced with long term care facilities. Experienced with IV infusion, clean room, and compounding. Janet has experience in payment and insurance procedures. Responsible for supervising, training and mentoring technicians.

Skills : Microsoft, Email Marketing, Sales Support, Sales Management, Purchasing, Purchasing, Management, Inventory Control, HVAC, Refrigeration.

Description :

    1. Prioritized Global Labelling activities and set clear targets using project management skills.
    2. Followed up with Global Labelling Team members to secure their contributions so that internal and external deadlines are met.
    3. Identified and assisted teams to overcome barriers in achieving quality and compliance For deliverables in scope, support responses to inquiries from colleagues and regulatory vendors related to inspection activities and regulatory agency questions Support the creation and review of Standard Operating Procedures and Work Instructions, for support of global labelling and regulatory related activities.
    4. Worked with cross functional regulatory teams on PBRERs, PSURs and other periodic aggregate safety reports.
    5. Generated compliance reviews of labelling repository and coordinate efforts in support of compliance and ensure that needed documents are accessible by the business.
    6. Critically edited Company Core labelling documents.
    7. Tracked and ensured proper the lifecycling of each CCDS.
Years of Experience
Experience
10+ Years
Experience Level
Level
Senior
Education
Education
Bachelor Of Science


Regulatory Associate Resume

Headline : Highly qualified Regulatory Associate with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and I would excel in the collaborative environment on which your company prides itself.

Skills : Legal Research, Contracts, Motion Practice, Federal Litigation, Regulatory Compliance.

Description :

    1. Generated documentation used to register nutritional supplement products for sale and distribution in countries outside of the USA.
    2. Researched dietary supplement registration requirements for import and export purposes.
    3. Developed Certificates of Analysis for existing and current products.
    4. Interfaced with vendors by phone, e-mail, and fax in collecting information on raw ingredients used in each product.
    5. Analyzed labels on packaging inserts, boxes, and cartons for grammatical errors, formulation issues, and weight discrepancies.
    6. Created and analyzed labels for a variety of nutritional supplements, cosmetics, and dietary shakes.
    7. Processed Certificates of Free Sale as requested by the client for submission with the Department of Health and Senior Services and the FDA.
Years of Experience
Experience
5-7 Years
Experience Level
Level
Junior
Education
Education
Diploma


Regulatory Associate Resume

Headline : To establish a long-term career in a company where I may utilize my Regulatory Associate professional skills and knowledge to be an effective Associate Program Manager and inspiration to those around me.

Skills : MS office, Planning Skills.

Description :

    1. Investigated and resolved data discrepancies and other inquiries within the company and as requested by the client.
    2. Created and reviewed Standard Operating Procedures for the department to ensure Regulatory Compliance.
    3. Composed correspondence/reports for manager signature.
    4. Assisted in the regulatory review and copy clearance of marketing pieces and promotional labeling of approved product labeling as necessary Collect references and cross-reference Core Labelling to source information to properly annotate the Core Labelling documents.
    5. Established network and SOP's to initiate process throughout all labs to systematically collect signed documents for Dossiers.
    6. Assisted formulators using an internal program for analyzing formulae for regulatory compliance in specific countries.
    7. Served as liaison to study monitors and sponsor representatives to assure efficient and timely submission of initial protocols, protocol amendments, safety reports and continuing reviews.
Years of Experience
Experience
5-7 Years
Experience Level
Level
Junior
Education
Education
GED

Regulatory Associate Resume

Headline : Providing Global Regulatory Strategy support as needed on development and marketed products. This support will include both strategic and operational activities.

Skills : C#, Java, SQL, Oracle Clinical, SSMS.

Description :

    1. Managed world-wide regulatory approvals for Class II Endoscopes and Class I Sterile products.
    2. Wrote, compiled and managed submissions for 510Ks, Health Canada Medical Device Applications and Fax Back Forms Compiling Technical Files for CE Mark.
    3. Obtained Certificates to Foreign Government, Certificates of Exportability and resolving custom issues.
    4. Maintained External Documents and ensuring current regulation files.
    5. Conducted, prepared audit reports and following up on internal and quality audits for two manufacturing facilities.
    6. Participated in ISO 13485and FDA audits.
    7. Analyzed customer complaints for possible MDR reporting.
Years of Experience
Experience
5-7 Years
Experience Level
Level
Junior
Education
Education
Certificate In Paralegal

Regulatory Associate Resume

Summary : Dedicated, hard-working, Regulatory Associate with nearly 20 years of experience in biomedical research support. For more than 15 years, roles have involved support of regulatory operations projects including the Regulatory Management Center for the National Institutes of Health (NIH) Division of Allergy, Immunology, and Transplantation (DAIT) and the Regulatory Operations Center (ROC) for the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID).

Skills : Experience In Quality Assurance And Regulatory Affairs.

Description :

    1. Assisted in the production of submissions and delivery of regulatory services in accordance with defined agency guidelines while balancing the quality and timeliness of customer deliverables.
    2. Provided basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumation, pagination, and formatting of reports and simple submissions.
    3. Performed quality assurance of published output for completeness and correctness in formatting and navigation; Run validation test scripts.
    4. Performed basic document management tasks including file transfer, storage, tracking, and archival.
    5. Sustained familiarity with departmental standard operating procedures and work instructions.
    6. Maintained current knowledge base of existing emerging global regulatory submission formats, industry standards and guidelines, software validation concepts and guidance documents - Exhibit excellent oral and written communication skills.
    7. Reviewed device changes and new products to determine regulatory pathway.
Years of Experience
Experience
10+ Years
Experience Level
Level
Senior
Education
Education
Bachelor's

Regulatory Associate Resume

Headline : Regulatory Associate, versed in EU, UK, and Canadian regulations. Results-oriented, with four years of extensive experience in the dietary supplements, cosmetics, and medical devices industry.

Skills : Regulatory Affairs, International Laws, EU Regulations, UK Regulations, Canadian Regulations, Agile, Oracle, Excel, Word, PowerPoint, French, Customer Service, Inventory Management, MBA.

Description :

    1. Kept Company up-to-date on regulatory changes for assigned markets of responsibility.
    2. Ensured that company's products comply with international legislation, guidelines, customer practices and regulations of all countries that the company is exporting to.
    3. Advised Marketing, Project Management, Research & Development and all others department involved in product development.
    4. Developed and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
    5. Undertook and managed regulatory inspections.
    6. Participated in CAPA, risk analysis and research & development meetings.
    7. Coordinated all safety reporting and distribution to breast oncology principal investigators.
Years of Experience
Experience
5-7 Years
Experience Level
Level
Executive
Education
Education
MBA

Regulatory Associate Resume

Summary : Responsible for Assisting with regulatory communications with the FDA for assigned products and activities, including preparing the FDA meeting requests, briefing book, meeting rehearsals/slides, meeting minutes of the FDA meetings, and the generation of responses to the FDA queries.

Skills : Administrative / Clerical, Customer Service, Accounts Rec/Pay, Verbal / Written Communication, Interpersonal, Problem-Solving Abilities, Dependability, Technical, Organization, Data Entry, Project Management, Event Planning, Billing, Cash Management.

Description :

    1. Categorized and recorded over 25,000 formulas into the global electronic filing system.
    2. Processed 5,000 Kosher Certifications requests, renewal & recorded on the global electronic file.
    3. Electronic communication.
    4. Extensive Excel spreadsheet and Word documentation.
    5. Created and modified formula specs, commercialized, and posted to the global network.
    6. Processed & verified SDS information using Optiva & IHS, recorded on the global network.
    7. Processed International Compliances documents & posted on the global network.
Years of Experience
Experience
7-10 Years
Experience Level
Level
Management
Education
Education
MS

Regulatory Associate Resume

Summary : Regulatory Associate with a strong science and healthcare background, along with ten years of Pharmaceutical Industry experience. Simultaneously supported and executed clinical trials of various indications, phases, and therapeutic areas. Experience in Drug Safety Event processing and procedures. Working knowledge of ICH-GCP Compliance Guidelines.

Skills : Managing Skills, Communication Skills.

Description :

    1. Generated, analyzed and interpreted information that supports food regulatory and food safety initiatives.
    2. Generated regulatory compliant food labeling or specification information and maintain supporting documentation.
    3. Technically supported and problem solved in food regulatory, quality and safety functions.
    4. Maintained product nutrient, ingredient, allergen and rework information, and documentation to meet needs of other internal departments; and assemble information into forms that best meet those needs.
    5. Ensured that issued and printed food packaging information and related materials comply with applicable laws and regulations.
    6. Collaborated with R&D, Sales & Marketing, Purchasing, Engineering, Manufacturing, and other functions to gather and validate labeling information, ingredient statements, and nutrition facts for new and existing products.
    7. Managed and supported special projects as needed.
              Years of Experience
              Experience
              7-10 Years
              Experience Level
              Level
              Management
              Education
              Education
              MS

              Regulatory Associate Resume

              Objective : To obtain a position where I can utilize my expertise in human relations, strong customer service/sales skills, and quality assurance experience. Working well independently and as part of a team. An energetic and highly effective team member, self-motivated, a productive individual with a positive attitude.

              Skills : Planning Skills, Regulatory System.

              Description :

                1. Performed QC checks of submissions from Clinical Research Sites for completeness, accuracy, and compliance to internal requirements, applicable regulations and notifies study sites regarding the status of their submission.
                2. Updated and implemented Standard Operating Procedures (SOPs) for the Protocol Registration Office.
                3. Participated in Working Group Meetings for DAIDS Protocol Registration System - Enterprise System Maintenance.
                4. Provided support for the transition to an updated operating system to insure that procedural requirements of the new system are adequate to support the existing process and incorporates improvements to the current process and operating system.
                5. Worked with software developers to verify that data migration from an existing operating system is complete and accurate.
                6. Developed validation procedures to verify the accuracy of the migrated data as well as the reporting capabilities of the syste.
                7. Managed regulatory submissions for breast cancer studies including sponsor, local IRB, cooperative and investigator-initiated studies.
              Years of Experience
              Experience
              2-5 Years
              Experience Level
              Level
              Executive
              Education
              Education
              Bachelors

              Regulatory Associate Resume

              Objective : Regulatory Associate professional with experience in launching and managing Phase I-III clinical trials including oncology (immunotherapy), endocrinology, pulmonary, and ENT studies. Capable project manager equipped with leadership skills to drive initiatives and complete projects on time and within budget. Skilled at creating network diagrams as well as schedule and cost estimates. Expert trainer in patient recruitment.

              Skills : Microsoft Office Suite, Desktop Publishing, Administrative Assistant/Clerical Support.

              Description :

                1. Interacted with hospital, private practice, and clinic staff utilizing telephone and email communications to obtain regulatory documentation necessary to initiate clinical studies at investigator sites.
                2. Maintained clinical investigator regulatory documentation files.
                3. Maintained and tracked investigator and study site information utilizing Microsoft Access and Microsoft Word software.
                4. Processed study site drug resupply requests.
                5. Generated study site document tracking reports as requested by clinical department.
                6. Composed study site correspondence and shipped study-related supplies to sites.
                7. Created and managed Technical Information Dossier for each formula developed in the United States as per the requirements of the 7th Amendment of the EU Cosmetics Directive.
              Years of Experience
              Experience
              2-5 Years
              Experience Level
              Level
              Executive
              Education
              Education
              MS