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2021 Regulatory Affairs Specialists Salary Guide

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

Regulatory Affairs Specialists Salary

Salary

$71.1K

Growth

5%

Bright Outlook

Bright

Green

No

Regulatory Affairs Specialists Job Description

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

Also known as:

Drug Regulatory Affairs Specialist, Regulatory Affairs Analyst (RA Analyst), Regulatory Affairs Associate (RA Associate), Regulatory Affairs Consultant (RA Consultant), Regulatory Affairs Specialist (RA Specialist), Regulatory Affairs Strategist (RA Strategist), Regulatory Engineer, Regulatory Services Consultant, Regulatory Specialist, Regulatory Submissions Associate

How Much Do Regulatory Affairs Specialists Make ? 2021

Percentile 10% 25% 50% (Median) 75% 90%
Annual Wage $40,160 $52,670 $71,100 $95,330 $115,220
Hourly Wage $19.31 $25.32 $34.18 $45.83 $55.39

How Much Do Regulatory Affairs Specialists Make ? 2021

Percentile
10%
25%
50% (Median)
75%
90%
Annual Wage
$40,160
$52,670
$71,100
$95,330
$115,220
Hourly Wage
$19.31
$25.32
$34.18
$45.83
$55.39

Regulatory Affairs Specialists Tasks

  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Coordinate recall or market withdrawal activities as necessary.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Identify relevant guidance documents, international standards, or consensus standards.
  • Identify relevant guidance documents, international standards, or consensus standards.
  • Identify relevant guidance documents, international standards, or consensus standards.
  • Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Participate in internal or external audits.
  • Compile and maintain regulatory documentation databases or systems.
  • Write or update standard operating procedures, work instructions, or policies.
  • Write or update standard operating procedures, work instructions, or policies.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
  • Develop or track quality metrics.
  • Develop or conduct employee regulatory training.
  • Recommend adjudication of product complaints.
  • Recommend adjudication of product complaints.
  • Recommend adjudication of product complaints.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
  • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
  • Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
  • Monitor national or international legislation on ozone-depleting substances or global warming.
  • Obtain clearances for the use of recycled plastics in product packaging.

What Activities Do Regulatory Affairs Specialists Do?

  • Coordinate regulatory documentation activities.
  • Obtain documentation to authorize activities.
  • Coordinate regulatory documentation activities.
  • Prepare regulatory or compliance documentation.
  • Coordinate regulatory documentation activities.
  • Prepare regulatory or compliance documentation.
  • Explain regulations, policies, or procedures.
  • Evaluate applicable laws and regulations to determine impact on organizational activities.
  • Oversee business processes.
  • Advise others on legal or regulatory compliance matters.
  • Examine product information to ensure compliance with regulations.
  • Examine product information to ensure compliance with regulations.
  • Compile technical information or documentation.
  • Evaluate applicable laws and regulations to determine impact on organizational activities.
  • Review documents or materials for compliance with policies or regulations.
  • Coordinate regulatory documentation activities.
  • Evaluate applicable laws and regulations to determine impact on organizational activities.
  • Update knowledge of legal or regulatory environments.
  • Communicate with government agencies.
  • Advise others on legal or regulatory compliance matters.
  • Examine financial records or processes.
  • Maintain data in information systems or databases.
  • Establish organizational guidelines or policies.
  • Prepare financial documents.
  • Update knowledge of legal or regulatory environments.
  • Analyze environmental regulations to ensure organizational compliance.
  • Monitor business indicators.
  • Train personnel in organizational or compliance procedures.
  • Investigate system, equipment, or product failures.
  • Recommend changes or corrective procedures.
  • Analyze data to identify or resolve operational problems.
  • Oversee business processes.
  • Correspond with customers to answer questions or resolve complaints.
  • Update knowledge of legal or regulatory environments.
  • Analyze environmental regulations to ensure organizational compliance.
  • Analyze environmental regulations to ensure organizational compliance.
  • Analyze environmental regulations to ensure organizational compliance.
  • Obtain documentation to authorize activities.

Typical Regulatory Affairs Specialists Knowledge?

  • English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
  • Law and Government - Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
  • Biology - Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
  • Computers and Electronics - Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.

What Are Typical Regulatory Affairs Specialists Abilities?

  • Written Comprehension - Reading and understanding what is written.
  • Written Expression - Communicating by writing.
  • Oral Expression - Communicating by speaking.
  • Oral Comprehension - Listening and understanding what people say.
  • Deductive Reasoning - Using rules to solve problems.
  • Inductive Reasoning - Making general rules or coming up with answers from lots of detailed information.
  • Problem Sensitivity - Noticing when problems happen.
  • Speech Clarity - Speaking clearly.
  • Speech Recognition - Recognizing spoken words.
  • Information Ordering - Ordering or arranging things.
  • Near Vision - Seeing details up close.

What Are Typical Regulatory Affairs Specialists Skills? 2021

  • Active Listening - Listening to others, not interrupting, and asking good questions.
  • Writing - Writing things for co-workers or customers.
  • Speaking - Talking to others.
  • Reading Comprehension - Reading work-related information.
  • Critical Thinking - Thinking about the pros and cons of different ways to solve a problem.
  • Judgment and Decision Making - Thinking about the pros and cons of different options and picking the best one.
  • Complex Problem Solving - Noticing a problem and figuring out the best way to solve it.
  • Systems Analysis - Figuring out how a system should work and how changes in the future will affect it.
  • Time Management - Managing your time and the time of other people.
  • Social Perceptiveness - Understanding people's reactions.

What Are Typical Regulatory Affairs Specialists Interests?

  • Conventional - Occupations related to Conventional interests frequently involve following set procedures and routines. They include working with data and details more than with ideas. Usually there is a clear line of authority to follow.
  • Enterprising - Occupations with Enterprising interests frequently involve starting up and carrying out projects. Many involve leading people and making many decisions. Sometimes they require risk taking and often deal with business.

What Is The Projected Employment For Regulatory Affairs Specialists ? 2021

Location 2019 Employment 2029 Employment Percent change Annual projected job openings
United States 337,600 353,200 5% 27,700

What Is The Projected Employment For Regulatory Affairs Specialists ? 2021

Location
2019 Employment
2029 Employment
Percent change
Annual projected job openings
United States
337,600
353,200
5%
27,700

What Is The Required Regulatory Affairs Specialists Education & Experience? 2021

  • Bachelor's degree
  • No work experience
  • 1 to 12 months on-the-job training

Regulatory Affairs Specialists Jobs Near Me .

Job Title Company Location Date Posted Federal Contractor
Center Medical Director (CMD) CSL Plasma McKeesport, Pennsylvania 06/21/2021 Yes
IRB Specialist I - Center for Clinical Research University Hospitals Health System Cleveland, Ohio 06/20/2021 No
Manager Regulatory Affairs, (Regulatory Scientist) WWD/LCI J&J Family of Companies Raritan, New Jersey 06/21/2021 Yes
Manager Regulatory Affairs, (Regulatory Scientist) WWD/LCI J&J Family of Companies Horsham, Pennsylvania 06/21/2021 Yes
Manager Regulatory Affairs, (Regulatory Scientist) WWD/LCI J&J Family of Companies Spring House, Pennsylvania 06/21/2021 Yes
Manager Regulatory Affairs, (Regulatory Scientist) WWD/LCI J&J Family of Companies Titusville, New Jersey 06/21/2021 Yes
Regulatory Affairs Manager II Randstad Cambridge, Massachusetts 06/21/2021 Yes
Regulatory Analyst University of Miami Miami, Florida 06/21/2021 No
Regulatory Services Analyst I Zurich NA Schaumburg, Illinois 06/21/2021 Yes
Scientific Affairs Specialist- Cromwell, CT DSM Cromwell, Connecticut 06/21/2021 Yes

Regulatory Affairs Specialists Jobs Near Me .

Job Title
Company
Location
Date Posted
Federal Contractor
CSL Plasma
McKeesport, Pennsylvania
06/21/2021
Yes
University Hospitals Health System
Cleveland, Ohio
06/20/2021
No
J&J Family of Companies
Raritan, New Jersey
06/21/2021
Yes
J&J Family of Companies
Horsham, Pennsylvania
06/21/2021
Yes
J&J Family of Companies
Spring House, Pennsylvania
06/21/2021
Yes
J&J Family of Companies
Titusville, New Jersey
06/21/2021
Yes
Randstad
Cambridge, Massachusetts
06/21/2021
Yes
University of Miami
Miami, Florida
06/21/2021
No
Zurich NA
Schaumburg, Illinois
06/21/2021
Yes
DSM
Cromwell, Connecticut
06/21/2021
Yes

Regulatory Affairs Specialists 2021 Salary Guide By State

Common Careers