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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

  • $82,260

    Average Salary

What Does A Regulatory Specialist Do At WPX Energy, Inc.

* Timely prepare and submit state and federal APDs, Sundry Notices and Completion Reports
* Perform completeness reviews for all needed components of federal and state APDs
* File other documentation as directed by supervisor or required by state and federal agencies
* Coordinate staking plats and infrastructure planning work with team members and contractors
* Review well survey and pad layout as well as other data needed for APD submittals
* Occasional travel may be required

What Does A Regulatory Specialist Do At Kelly Services

* Implement and maintain raw material documentation storage system which would include preparing/organizing information for Optiva upload; finalizing/creating documentation in Optiva using the data uploaded for customer documentation.
* Create and/or update technical data including specification sheet, nutritional, ingredient breakdown, Allergen information, certificate of origin.
* Create other documentation such as GMO, Organic, Vegan, etc. as requested.
* Review and complete customer forms or specific customer request as assigned.
* Learn or work on areas such as SDS creation, Reformation/Commercialization Regulatory tasks, Kosher, Halal, Organic, Raw material approval process.
* Ability to work closely with R & D, Sales, and Customer Service.
* If needed, ability to register or approve alternate/replacement Raw materials
* Contact suppliers as necessary.
* Assist in maintenance of raw material database.
* Completion of assignments as assigned

What Does A Regulatory Specialist Do At Johns Hopkins University

* Provide assistance in the submission of Investigational New Drug Applications (IND)
* Provide regulatory guidance to IND sponsors, clinical investigators, and clinical staff for investigator initiated clinical trials
* Provide assistance with IND management and submissions
* Coordinate and review documentation for amendments, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs
* Compile and maintain IND Sponsor regulatory files (digital and hard-copy) throughout the lifecycle of sponsorship by ensuring that incoming and historical documents are organized and filed appropriately
* Review clinical trial databases to assess clinical data quality and accuracy
* Monitor investigational drug supply

What Does A Regulatory Specialist Do At Glaxosmithkline

* Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labeling outputs, license maintenance and lifecycle management dossiers and regulatory information management.
* GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).
* In this role you have an opportunity to work closely with GMS Programs group who deliver Supply Chain Transformation and major programmes being driven by GMS that are vital to our success as we continue to seek opportunities to simplify and drive compliance.
* If you are self-motivated, enjoy a challenge and seek satisfaction knowing your efforts are making a difference in someone’s life, then this opportunity is for you.
* In your new role you will:
* take part in a challenging projects related to the API and DP source transfers and other programs driven by GMS,
* support the Team in multiple regulatory activities and in preparation of appropriate CMC modules and variation dossiers for GSK pharma products,
* acquire knowledge of regulations, guidelines, procedures and policies relating to the registration and manufacturing of pharmaceutical products,
* communicate regularly with Regulatory Manager/Team Lead to help in identification of any issues with business impact,
* monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
* interact with global regulatory groups and local operating companies to deliver compliant and timely dossiers,
* build and maintain quality relations with your internal and external stakeholders.
* Why You

What Does A Regulatory Specialist Do At General Atomics and Affiliated Companies

* Ensures documentation compliance with appropriate regulations.
* Submissions are produced with electronic publishing tools in compliance with document management standards and appropriate regulations.
* Essential Functions:
* Participate in activities related to regulatory management systems, including ensuring compliance with appropriate regulatory requirement, systems coordination, developing and implementing plans, and providing input to systems designs.
* Prepare, analyze, track, index and archive paper and electronic submissions including information such as amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
* May represent the group with internal customers.
* Review documentation formatting standards, policies, and procedures to ensures they meet requirement's and may participate in audits of the same.
* Maintains an awareness of regulatory changes or rulings to ensure compliance of regulatory submissions; analyzes special programs and may recommend changes to existing programs or implementations of new programs.
* Responsible for ensuring all laws, regulations and other applicable obligations are observed wherever and whenever business is conducted on behalf of the Company.
* Responsible for ensuring work is accomplished in a safe manner in accordance with established operating procedures and practices
* Additional Functions: other duties as assigned

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Regulatory Specialist jobs

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Regulatory Specialist Career Paths

Regulatory Specialist
Quality Engineer Quality Assurance Manager Operations Manager
Assistant Vice President
7 Yearsyrs
Business Analyst Product Manager General Manager
Chief Operating Officer
11 Yearsyrs
Operations Analyst Team Manager Clinical Manager
Clinical Operations Manager
10 Yearsyrs
Supervisor Licensed Practical Nurse Clinical Research Coordinator
Clinical Study Manager
8 Yearsyrs
Research Analyst Research Manager Clinical Research Manager
Clinical Trial Manager
10 Yearsyrs
Substitute Teacher Licensed Practical Nurse Clinical Research Coordinator
Clinical Trials Specialist
8 Yearsyrs
Senior Specialist Senior Manager Global Director
Director Global Operations
13 Yearsyrs
Operations Analyst Program Manager Clinical Director
Director Of Clinical Operations
13 Yearsyrs
Office Manager Human Resources Coordinator
Director Of Human Resources
10 Yearsyrs
Project Manager Program Manager General Manager
Operations Director
9 Yearsyrs
Project Manager Construction Manager
Operations Manager
7 Yearsyrs
Regulatory Affairs Manager Senior Manager Operations Director
President Of Operations
11 Yearsyrs
Regulatory Affairs Manager Quality Assurance
Quality Assurance Manager
9 Yearsyrs
Regulatory Affairs Specialist Regulatory Affairs Manager
Regulatory Affairs Director
12 Yearsyrs
Quality Engineer Senior Quality Engineer Quality Assurance Manager
Regulatory Affairs Manager
9 Yearsyrs
Research Analyst Research Consultant
Senior Clinical Research Associate
10 Yearsyrs
Office Manager Human Resources Assistant Human Resources Generalist
Senior Human Resources Generalist
7 Yearsyrs
Regulatory Affairs Specialist Project Manager Program Manager
Senior Manager
10 Yearsyrs
Business Analyst Assistant Vice President
Vice President And Manager
10 Yearsyrs
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Regulatory Specialist Demographics

Gender

  • Female

    69.2%
  • Male

    28.6%
  • Unknown

    2.2%

Ethnicity

  • White

    78.9%
  • Asian

    9.9%
  • Hispanic or Latino

    9.1%
  • Unknown

    1.4%
  • Black or African American

    0.8%
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Languages Spoken

  • Spanish

    43.2%
  • French

    10.8%
  • German

    8.1%
  • Mandarin

    6.8%
  • Chinese

    5.4%
  • Vietnamese

    2.7%
  • Russian

    2.7%
  • Carrier

    2.7%
  • Portuguese

    2.7%
  • Romanian

    1.4%
  • Hindi

    1.4%
  • Dutch

    1.4%
  • Sindhi

    1.4%
  • Korean

    1.4%
  • Indonesian

    1.4%
  • Ukrainian

    1.4%
  • Tibetan

    1.4%
  • Nepali

    1.4%
  • Italian

    1.4%
  • Comanche

    1.4%
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Regulatory Specialist

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Regulatory Specialist Education

Regulatory Specialist

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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
CMC Regulatory Specialist P & L Development LLC Westbury, NY Oct 01, 2015 $77,000
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
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
Senior Regulatory Specialist New York University School of Medicine New York, NY Apr 01, 2015 $75,000
Compliance & Regulatory Specialist Abaline Supply Company Port Reading, NJ Aug 14, 2013 $74,109
Regulatory Publishing Specialist Vividstarts LLC VA Sep 01, 2015 $72,800
Senior Regulatory Specialist Fresenius KABI USA, LLC Lake Zurich, IL Apr 20, 2015 $66,102 -
$82,000
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

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Top Skills for A Regulatory Specialist

RegulatoryComplianceProceduresRegulatoryDocumentsSafetyReportsDataEntryClinicalTrialsInvestigativeSitesRegulatoryBindersEPARegulatoryAgenciesRegulatorySubmissionsEnsureComplianceRegulatoryRequirementsCustomerServiceAnnualReportsInstitutionalReviewBoardsResourceICHGuidelinesFDAGcpsCMC

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Top Regulatory Specialist Skills

  1. Regulatory Compliance
  2. Procedures
  3. Regulatory Documents
You can check out examples of real life uses of top skills on resumes here:
  • Reviewed and recommended changes for labeling for regulatory compliance.
  • Validate the integrity of current compliance policies and procedures by overseeing periodic compliance state reviews.
  • Maintained a constant workload of completed regulatory documents averaging 30-40 packets processed per day.
  • Submitted electronic safety reports to the FDA; trained relevant staff on electronic submission.
  • Managed and reviewed data entry of required health facility information into federal and state databases.

Top Regulatory Specialist Employers

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Regulatory Specialist Videos

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

Designing Your Career as a Regulatory Professional

Regulatory Affairs Job - North Yorkshire

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