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Become A Regulatory Specialist

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Working As A Regulatory Specialist

  • Evaluating Information to Determine Compliance with Standards
  • Getting Information
  • Updating and Using Relevant Knowledge
  • Interacting With Computers
  • Communicating with Supervisors, Peers, or Subordinates
  • Mostly Sitting

  • $71,273

    Average Salary

What Does A Regulatory Specialist Do At Beth Israel Deaconess Medical Center

* Prepare and submit applications, including preparation of consent forms to the DFHCC IRB on all cancer center clinical trials (industry, cooperative groups and PI initiated studies), and respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients.
* Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations and deviations to study protocols
* Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoots processes and procedures when issues are identified.
* Assist investigators and study teams in preparing and submitting IND applications to the FDA.
* Preparation and submission of annual reports to the FDA.
* Submission of regulatory documents to NIH/OBA, local bio safety committees on oncology human gene transfer trials.
* Act as a liaison between the DFHCC IRB and investigator to resolve regulatory queries and concerns.
* Assist in the preparation and implementation of regulatory office SOPs

What Does A Regulatory Specialist Do At Tyson Foods

* Create label copy based on managers input for ingredient statements and nutritionProof read graphics developed from Label CopySubmit label applications to USDA for Sketch Approvals, Child Nutrition (CN) approvals via LSAS system and manage process through approval to posting in DevExCreate Generic Approvals based on guidance from regulatory managers and post to DevExAssist in the maintenance of PLM system for Regulatory tasks, Global and Plant label specifications
* Maintain central label control for finals, temporary and extensions of USDA approvalsCommunication with manufacturing facilities including co-manufacturers regarding label approvals
* Participate in cross-functional team meetings for new projectsSupply nutrition/ product information as needed to customers, marketing, and sales force.o Letters of Guaranteeo Certificates of Insuranceo Customer ( i.e
* Walmart, Sysco) Questionnaireso Assist Consumer AffairsAll other duties as assigned Bachelor Science Degree in Food Science or related field preferredOne to five years experience in food safety, regulatory and/or quality with food products preferredKnowledge of Regulatory and Food LawExperience with FSIS label approval process preferredKnowledge of food safety principles and food processingHACCP Certified preferredComputer software knowledge in Excel, Access, SAP, Genesis, Product VisionEffective written and verbal communication skills with internal customers, external suppliers and co-manufacturers.
* Tyson is an Equal Opportunity/Affirmative Action Employer.
* All qualified applicants will be considered without regard to race, national origin, color, religion, age, genetics, sex, sexual orientation, gender identity, disability or veteran

What Does A Regulatory Specialist Do At Exelon Corporation

* Provide governance, tactical oversight, and support at the station level for implementation of individual Performance Improvement Program processes and any associated activities including the improvement of these tools.
* Continuously improve performance improvement program execution to increase efficiency and results of the program and ensure effective identification, screening, analysis, resolution, implementation and measurement of performance issues.
* Perform additional functions of related performance improvement program processes as necessary to support the site.
* POSITION SPECIFICATIONS
* Minimum:
* High School Diploma and a minimum of 5 years directly

What Does A Regulatory Specialist Do At Stanford University

* Independently develop, draft and compile research protocol documents and all materials required for regulatory submissions in compliance with University and external policies.
* Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.
* Facilitate and participate in committee meetings, ensure procedures are followed.
* Responsible for compiling, organizing, and storing all session documentation and communicating results as appropriate.
* Revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response; advise investigator on remedies and revisions.
* Maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents.
* May assist with registering and reporting of clinical trials, i.e. ClinicalTrials.gov.
* Qualifications

What Does A Regulatory Specialist Do At Grifols Shared Services North America, Inc.

* Act as Regulatory Affairs representative for specified key products/facilities/equipment.
* Prepare complex submissions to various governmental agencies and ensure contents are in compliance with domestic and international regulatory requirements.
* Prepare recurrent and routinely requested data, listing, and notifications for assigned projects for submission to regulatory
* Prepare official submissions to regulatory agencies for new or modified products.
* Compile regulatory submissions through coordination with other departments and research of internal documentation, complete applications and forms, compose cover letters and summaries, assemble/format submissions in such a manner to facilitate the review process
* Inform other departments on new regulatory developments.
* Research regulations and guidelines and interact with domestic and international regulatory counterparts to provide effective regulatory assessment of proposed changes to products/facilities/equipment.
* Ensure quality standards for submission dossier/reports in conformance with agency requirements and e-submission readiness.
* Support clinical publishing in accordance with ICH/FDA guidelines

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Regulatory Specialist Jobs

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Regulatory Specialist Demographics

Gender

Female

69.2%

Male

28.6%

Unknown

2.2%
Ethnicity

White

61.4%

Hispanic or Latino

13.5%

Black or African American

12.2%

Asian

9.6%

Unknown

3.3%
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Foreign Languages Spoken

Spanish

41.1%

French

11.0%

German

8.2%

Mandarin

6.8%

Chinese

5.5%

Vietnamese

2.7%

Hindi

2.7%

Russian

2.7%

Carrier

2.7%

Portuguese

2.7%

Romanian

1.4%

Dutch

1.4%

Sindhi

1.4%

Korean

1.4%

Indonesian

1.4%

Ukrainian

1.4%

Bosnian

1.4%

Tibetan

1.4%

Nepali

1.4%

Albanian

1.4%
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Regulatory Specialist Education

Schools

Florida State University

15.1%

Tallahassee Community College

13.2%

University of Phoenix

12.2%

Michigan State University

5.9%

Northeastern University

5.9%

Florida Agricultural and Mechanical University

5.4%

Temple University

3.9%

Johns Hopkins University

3.9%

Capella University

3.9%

University of North Carolina at Wilmington

3.9%

American InterContinental University

3.4%

Harvard University

2.9%

Stephen F Austin State University

2.9%

University of Cincinnati

2.9%

George Washington University

2.4%

Southern Illinois University Carbondale

2.4%

Pennsylvania State University

2.4%

Durham Technical Community College

2.4%

Eastern Michigan University

2.4%

Wichita State University

2.4%
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Majors

Business

26.2%

Biology

8.2%

Health Care Administration

5.9%

Pharmacy

5.6%

Chemistry

5.6%

Law

5.4%

Psychology

5.0%

Environmental Science

4.8%

Accounting

4.0%

Management

3.8%

Criminal Justice

3.6%

Public Health

3.1%

Nursing

3.1%

Education

2.7%

Political Science

2.5%

Legal Support Services

2.3%

Human Resources Management

2.3%

Public Administration

2.1%

Sociology

1.9%

Marketing

1.9%
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Degrees

Bachelors

40.2%

Masters

25.4%

Other

15.4%

Associate

6.5%

Certificate

5.8%

Doctorate

5.7%

Diploma

0.7%

License

0.2%
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Job type you want
Full Time
Part Time
Internship
Temporary

Real Regulatory Specialist Salaries

Job Title Company Location Start Date Salary
Director, Senior Regulatory Specialist UBS Asset Management (Americas) Inc. New York, NY Dec 12, 2016 $200,000 -
$250,000
CMC Regulatory Specialist P & L Development LLC Westbury, NY Sep 05, 2016 $141,232
Principal Regulatory CMC Specialist Upsher-Smith Laboratories, Inc. Maple Grove, MN Sep 28, 2013 $115,360
Regulatory Specialist The Fountain Group LLC Cambridge, MA Aug 25, 2016 $104,350
Regulatory Publishing Specialist Vividstarts LLC Cambridge, MA Sep 01, 2015 $104,000
Regulatory Specialist Biomarin Pharmaceutical Inc. Novato, CA Sep 30, 2015 $98,208 -
$147,312
SR. Regulatory Specialist I Roche Molecular Systems, Inc. Pleasanton, CA Feb 05, 2016 $96,387 -
$113,712
Senior International Regulatory Specialist Immucor, Inc. Norcross, GA Apr 15, 2013 $90,000
Regulatory Submissions Specialist Sunovion Pharmaceuticals, Inc. Marlborough, MA Nov 21, 2014 $88,385
Regulatory Submissions Specialist Sunovion Pharmaceuticals, Inc. Marlborough, MA Jun 06, 2014 $88,385
SR. Regulatory Specialist Givaudan Fragrances Corporation East Hanover, NJ Apr 12, 2016 $87,062
Regulatory Specialist Abbott Laboratories Santa Clara, CA Jul 25, 2016 $86,000
SR. Regulatory and Food Law Specialist Mead Johnson & Company LLC Evansville, IN Sep 14, 2013 $85,000
Regulatory Specialist Conocophillips Company Houston, TX Sep 19, 2015 $76,214 -
$101,160
Regulatory Specialist Avery Dennison Corporation Mentor, OH May 18, 2015 $75,000
Senior Regulatory Specialist New York University School of Medicine New York, NY Apr 01, 2015 $75,000
Regulatory Specialist Philips Medical Systems (Cleveland), Inc. Highland Heights, OH Jan 03, 2016 $75,000
Regulatory Reproting Specialist Axiom Software Laboratories, Inc. Bedford, NH Jan 19, 2015 $75,000
Regulatory Publishing Specialist Vividstarts LLC VA Sep 01, 2015 $72,800
Regulatory Specialists Ventois, Inc. Shrewsbury, MA Jan 09, 2016 $72,000
International Regulatory Specialist EP Technology Corporation Fremont, CA Aug 26, 2015 $71,802
Regulatory Specialist III Acumed LLC Hillsboro, OR Feb 28, 2013 $65,675 -
$98,645
Regulatory Specialist Orthofix Incorporated Lewisville, TX May 14, 2013 $65,000
Regulatory Submission Publishing Specialist Tata Consultancy Services Limited Philadelphia, PA Sep 20, 2015 $64,500
Regulatory Submissions Specialist Unicon Pharma Inc. Ardsley, NY Aug 21, 2016 $62,462
Alcohl Regulatory Specialist Lehrman Beverage Law, PLLC Oakton, VA Sep 01, 2013 $60,260
Alcohol Regulatory Specialist Lehrman Beverage Law, PLLC Oakton, VA Aug 31, 2013 $60,260
Regulatory Specialist Esjay Pharma LLC East Windsor, NJ Jan 08, 2016 $60,129
Regulatory Submissions Specialist Intone Networks Inc. Arlington, VA Jul 14, 2015 $60,000

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Top Skills for A Regulatory Specialist

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  1. Compliance
  2. Regulatory Documents
  3. Procedures
You can check out examples of real life uses of top skills on resumes here:
  • Reviewed television, print and web marketing collateral to ensure compliance with federal and state accreditation regulations and internal marketing rules.
  • Work with regulatory team members to secure authorization of regulatory documents and in preparation of regulatory submissions per work instructions.
  • Created and implemented procedures and coordinated all activities associated with international inventories, product registration, notification and global hazard communication.
  • Served as regulatory contact person for representatives from sponsoring pharmaceutical and device firms and FDA for review of regulatory records.
  • Compile all Close-Out documents and ensure all IND Safety Reports have been acknowledged by the IRB.

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Top 10 Best States for Regulatory Specialists

  1. Alaska
  2. District of Columbia
  3. Minnesota
  4. Massachusetts
  5. Delaware
  6. Texas
  7. Rhode Island
  8. Connecticut
  9. North Dakota
  10. Michigan
  • (29 jobs)
  • (111 jobs)
  • (372 jobs)
  • (492 jobs)
  • (49 jobs)
  • (785 jobs)
  • (40 jobs)
  • (113 jobs)
  • (37 jobs)
  • (381 jobs)

Top Regulatory Specialist Employers

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Jobs From Top Regulatory Specialist Employers

Regulatory Specialist Videos

Career Pathways: Breaking into the Business of Regulatory Affairs & Biotechnology

Designing Your Career as a Regulatory Professional

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