Regulatory Associate Salary in the US
Regulatory Affairs Associate Salary Range
$77,370
$100,075
Low Range
High Range
Midpoint
This salary range represents a national benchmark in USD. Regional salary adjustment factors can be applied below to estimate how compensation may shift by state.
Salary benchmarks are based on a mix of TQR internal data and external market research for specialized manufacturing and technical roles in the U.S.
Regulatory Affairs Associate salaries in the Life Sciences Manufacturing industry typically range from $77,370 to $100,075, with a midpoint of approximately $87,015. Compensation varies based on regulatory experience, product knowledge, submission expertise, therapeutic area specialization, global regulatory exposure, company size, and overall responsibility for supporting regulatory compliance and product registrations.
What the Salary Percentiles Mean
The following range has been generated based on real salary data across North America.
$77,370
$100,075
$77,370
25th percentile
Employees in this section often have a lower level of experience or skills and
are still growing into their role. This role may also be at a small to medium-sized business.
$87,015
50th percentile
Employees in this section typically demonstrate the required level of experience plus many skills that are deemed an asset. This role is likely at a medium-sized business.
$100,075
75th percentile
Employees in this section typically demonstrate a higher-level of expertise and/or enhanced qualifications. They should also have a proven track record and cultural fit. This role is likely at a larger business.
Regional Salary Adjustments
Salary ranges can vary by region based on cost of living, labor competition, industry concentration, and talent availability. The map below shows regional adjustment factors that can be applied to the national salary benchmark as a directional guide.
Factors That Affect a Regulatory Affairs Associate's Salary
Regulatory Affairs Associate compensation can vary based on regulatory experience, product portfolio complexity, submission responsibilities, global regulatory exposure, therapeutic area specialization, company size, geographic location, and overall compliance accountability. Employers may need to adjust compensation when the position supports multiple international markets, complex regulatory submissions, medical device classifications, or highly regulated pharmaceutical and biotechnology products.
Regulatory Associate Job Description:
A Regulatory Affairs Associate supports regulatory activities that ensure pharmaceutical, biotechnology, medical device, diagnostics, and other Life Sciences products comply with applicable domestic and international regulatory requirements throughout the product lifecycle. This role helps prepare regulatory submissions, maintain product registrations, manage regulatory documentation, and support compliance initiatives that enable successful product approvals and commercialization.
Regulatory Affairs Associates typically prepare and maintain regulatory submissions, support product registrations, manage technical documentation, maintain regulatory records, monitor regulatory changes, and assist with agency communications while working closely with Research & Development, Quality Assurance, Manufacturing, Clinical, Supply Chain, and Regulatory Affairs teams. Their responsibilities may include document control, product labelling support, change control, post-market regulatory activities, regulatory intelligence, and maintaining submission dossiers for domestic and global markets.
Regulatory Affairs Associates are expected to understand how regulatory compliance directly impacts product approvals, market access, product quality, patient safety, and overall business success. Strong candidates typically combine regulatory knowledge, attention to detail, organizational ability, communication skills, document management expertise, and analytical thinking while supporting regulatory compliance within highly regulated Life Sciences manufacturing environments.
Common Responsibilities:
Preparing, compiling, reviewing, and maintaining regulatory submissions, product registrations, technical documentation, and supporting dossiers for domestic and international regulatory agencies.
Supporting product registrations, regulatory approvals, renewals, labelling updates, and lifecycle management activities while ensuring timely and accurate regulatory submissions.
Ensuring compliance with FDA, cGMP/GMP, ISO, ICH, MDR/IVDR, and other applicable domestic and international regulatory requirements throughout the product lifecycle.
Collaborating with Research & Development, Quality Assurance, Manufacturing, Clinical, Supply Chain, and Regulatory Affairs teams to support product development, regulatory compliance, and commercialization activities.
Maintaining regulatory records, technical files, document control systems, change control documentation, and post-market regulatory records while ensuring document accuracy and integrity.
Supporting responses to regulatory agency inquiries, inspections, audits, requests for additional information, and continuous improvement initiatives while monitoring evolving global regulatory requirements.
Assisting with regulatory reporting, risk assessments, product labelling, SOP development, compliance documentation, and process improvements to strengthen regulatory operations and organizational compliance.
Explore Current Openings
TQR recruits for specialized roles across industrial automation, manufacturing, packaging, food production, life sciences, and related technical markets. Current openings may include engineering, operations, maintenance, quality, supply chain, and plant leadership roles.
View current opportunities or submit your resume to be considered for future roles that match your background.
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