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Entry Level Regulatory Affairs Associate Jobs (NOW HIRING)

Stark Pharma Solutions Inc

IL · On-site

I am working on Regulatory Affairs Associate I position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed is as follows. Job ...

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Entry Level Regulatory Affairs Associate information

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How much do entry level regulatory affairs associate jobs pay per hour?

As of Jun 25, 2026, the average hourly pay for entry level regulatory affairs associate in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What are some common challenges faced by Entry Level Regulatory Affairs Associates when adapting to regulatory changes?

Entry Level Regulatory Affairs Associates often encounter the challenge of staying up to date with frequent changes in local and international regulations. Adapting quickly requires strong research skills and attention to detail, as new guidelines can impact submission processes or product compliance. Collaborating closely with cross-functional teams, such as quality assurance and product development, is essential to ensure that all documentation aligns with the latest requirements. Proactively seeking mentorship and participating in training sessions can help new associates navigate these shifts more efficiently.

What does an Entry Level Regulatory Affairs Associate do?

An Entry Level Regulatory Affairs Associate supports the regulatory affairs team by helping to ensure that products comply with all relevant regulations and standards. This often includes preparing and submitting documentation to regulatory agencies, assisting with product registrations, and maintaining records. They also help to monitor changes in regulations and communicate important updates to internal teams. This role is essential for companies in industries like pharmaceuticals, medical devices, and biotechnology to bring products to market legally and efficiently.

What are the key skills and qualifications needed to thrive as an Entry Level Regulatory Affairs Associate, and why are they important?

To thrive as an Entry Level Regulatory Affairs Associate, you need a background in life sciences or related fields, strong attention to detail, and knowledge of regulatory guidelines and documentation. Familiarity with regulatory submission systems, document management tools, and sometimes certifications like RAC (Regulatory Affairs Certification) can be beneficial. Strong organizational skills, clear written and verbal communication, and the ability to work collaboratively make candidates stand out. These skills and qualifications are essential for ensuring compliance, timely submissions, and effective coordination in the highly regulated healthcare or pharmaceutical industries.

What is the difference between Entry Level Regulatory Affairs Associate vs Regulatory Affairs Specialist?

AspectEntry Level Regulatory Affairs AssociateRegulatory Affairs Specialist
QualificationsBachelor's degree in life sciences or related field; some certifications optionalBachelor's or master's degree; certifications like RAC beneficial
Work EnvironmentEntry-level, supporting regulatory documentation and researchMore independent, managing submissions and compliance strategies
Industry UsageCommonly used for early-career roles in pharma, biotech, medical devicesUsed for mid-level roles with increased responsibilities

Entry Level Regulatory Affairs Associates typically handle foundational tasks like document preparation and research, requiring basic industry knowledge. Regulatory Affairs Specialists have more experience, managing submissions and compliance strategies. Both roles are essential in regulated industries like pharmaceuticals and medical devices, but the Specialist role involves greater responsibility and independence.

More about Entry Level Regulatory Affairs Associate jobs
What cities are hiring for Entry Level Regulatory Affairs Associate jobs? Cities with the most Entry Level Regulatory Affairs Associate job openings:
What states have the most Entry Level Regulatory Affairs Associate jobs? States with the most job openings for Entry Level Regulatory Affairs Associate jobs include:
What job categories do people searching Entry Level Regulatory Affairs Associate jobs look for? The top searched job categories for Entry Level Regulatory Affairs Associate jobs are:
Entry Level Regulatory Affairs Associate jobs near you
Infographic showing various Entry Level Regulatory Affairs Associate job openings in the United States as of June 2026, with employment types broken down into 4% As Needed, 10% Full Time, 82% Part Time, 3% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory Affairs Associate

Stark Pharma Solutions Inc

Piscataway, NJ • On-site

Contractor

Posted 21 days ago

Job description

Hi,

My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Role: Regulatory Affairs Associate

Location: United States

Duration: Long Term contract

Position Summary

We are seeking a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices, pharmaceuticals, biotechnology products, or combination products. The successful candidate will assist in preparing regulatory submissions, maintaining regulatory documentation, monitoring compliance requirements, and supporting product registrations to ensure adherence to FDA and global regulatory standards.

Key Responsibilities

  • Prepare, compile, review, and submit regulatory documentation to support product approvals and registrations.
  • Assist in the preparation of FDA submissions, including 510(k), PMA, IND, NDA, ANDA, or other regulatory filings as applicable.
  • Support regulatory strategy development for new products, product modifications, and market expansions.
  • Maintain regulatory files, product registrations, licenses, and submission records.
  • Review product labeling, promotional materials, and technical documentation for regulatory compliance.
  • Monitor changes in U.S. and international regulations and communicate regulatory impacts to internal stakeholders.
  • Collaborate with Quality Assurance, R&D, Clinical, Manufacturing, and Marketing teams to support regulatory initiatives.
  • Assist with regulatory agency correspondence, inspections, audits, and information requests.
  • Support change control assessments and evaluate regulatory impact of product or process changes.
  • Participate in cross-functional project teams to ensure timely regulatory deliverables.

Required Qualifications

  • Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, Biology, Chemistry, Biomedical Engineering, or a related scientific discipline.
  • 1–3 years of Regulatory Affairs experience within the pharmaceutical, biotechnology, medical device, or healthcare industry.
  • Working knowledge of FDA regulations, guidance documents, and regulatory submission processes.
  • Strong technical writing, documentation, and organizational skills.
  • Ability to manage multiple projects and deadlines in a fast-paced environment.
  • Excellent verbal and written communication skills.