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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 ...

ITW Car Care

Regulatory Affairs Associate

Lakeland, FL · Hybrid

Position Summary The Regulatory Affairs Associate supports the organization's product stewardship and regulatory compliance programs by ensuring products meet applicable environmental, health, safety ...

Abbott

Regulatory Affairs Associate

South Portland, ME · On-site

$19 - $21/hr

Regulatory Affairs Associate Location: South Portland, ME Duration: 12 Months Shifts: 8AM TO 4:30PM 100% Onsite Main Responsibilities: * As the Experienced para-professional in the Regulatory Affairs ...

Bimeda Inc.

Regulatory Affairs Associate

Houston, TX · On-site

The Regulatory Affairs Associate builds and maintains strong relationships with colleagues in Quality and Commercial ensuring optimal compliance from cGMP and Regulatory standpoint. Key Role Specific ...

IMMY

Regulatory Affairs Associate

Norman, OK · Remote

S. Job Purpose The Regulatory Affairs Associate/Specialist is primarily responsible for preparing IVD regulatory documents for submission to various regulatory agencies, both domestic and ...

New

Bimeda Inc.

Regulatory Affairs Associate

Houston, TX · On-site

The Regulatory Affairs Associate builds and maintains strong relationships with colleagues in Quality and Commercial ensuring optimal compliance from cGMP and Regulatory standpoint. Key Role Specific ...

Abbott

$40 - $46/hr

Regulatory Affairs Associate Location: Sylmar, CA Duration: 7 Months 100% Onsite Summary: Responsible for filing necessary regulatory applications and supporting interactions with U.S. and ...

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Regulatory Affairs Associate information

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$62

How much do regulatory affairs associate jobs pay per hour?

As of Aug 24, 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 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.

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.
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Regulatory Affairs Associate jobs near you
Infographic showing various Regulatory Affairs Associate job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 69% Full Time, 28% Part Time, 1% Temporary, and 1% Contract. 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

Re-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.