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Regulatory Affairs Associate Jobs (NOW HIRING)

Lancesoft

Regulatory Affairs Associate II

Princeton, NJ · On-site

$50 - $55/hr

Regulatory Affairs Associate II Hybrid working once fully trained. More on site presence whilst training. Role Purpose: Regulatory contractor for data management including data entry, review and ...

Eurofins

Regulatory Affairs Associate

Kalamazoo, MI · On-site

We are seeking an experienced Regulatory Affairs Associate to support our Human Health and Animal Health Diagnostics Groups, specifically focused on regulatory submissions and compliance. This role ...

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How much do regulatory affairs associate jobs pay per hour?

As of Jun 12, 2026, the average hourly pay for 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 Is a Regulatory Affairs Associate?

A regulatory affairs associate helps medical and pharmaceutical companies navigate regulatory approval processes so that products conform to all local, state, and federal regulations. As a regulatory affairs associate, you work with a team to obtain approval for products, maintain database systems for relevant information, and create reports required by federal or government agencies. You stay abreast of developments in legislation and regulation that may affect your company, and advise others on best practices for product development within a regulated framework.

What are Regulatory Affairs Associates?

Regulatory Affairs Associates are professionals who help ensure that companies comply with all regulations and laws applicable to their products, particularly in industries like pharmaceuticals, medical devices, and biotechnology. They are responsible for preparing and submitting documentation to regulatory agencies, maintaining records, and assisting with product approvals. Their work is crucial for bringing safe and effective products to market while meeting all legal requirements.

What are some common challenges Regulatory Affairs Associates face when coordinating with cross-functional teams?

Regulatory Affairs Associates often collaborate closely with departments such as research and development, quality assurance, and marketing. A common challenge is ensuring all stakeholders understand and adhere to regulatory requirements, which may change frequently. Balancing project timelines with the need for accurate and compliant documentation can also be demanding, especially when teams have competing priorities. Effective communication and proactive planning are key to navigating these challenges successfully.

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

To thrive as a Regulatory Affairs Associate, you need a solid background in life sciences or related fields, attention to detail, and knowledge of regulatory guidelines and standards. Familiarity with submission management systems, regulatory databases, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Strong organizational skills, effective communication, and the ability to work collaboratively are important soft skills in this role. These abilities ensure accurate documentation, timely regulatory submissions, and successful navigation of complex compliance requirements.
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Regulatory Affairs Associate jobs near you

Regulatory Affairs Associate

Stark Pharma Solutions Inc

Piscataway, NJ • On-site

Contractor

Posted 8 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.