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Regulatory Affairs Associate Ii 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

... 2-in-1 Glass Cleaner. Black Magic to support all your wheel and tire needs including Tire Wet ... Position Summary The Regulatory Affairs Associate supports the organization's product stewardship ...

Bimeda Inc.

Regulatory Affairs Associate

Houston, TX · On-site

The Regulatory Affairs Associate builds and maintains strong relationships with colleagues in ... Minimum of two (2) years of experience working in a professional office or laboratory environment ...

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 ...

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Regulatory Affairs Associate Ii information

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How much do regulatory affairs associate ii jobs pay per hour?

As of Aug 30, 2026, the average hourly pay for regulatory affairs associate ii 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 does a Regulatory Affairs Associate II do?

A Regulatory Affairs Associate II is responsible for ensuring that a company's products meet all regulatory requirements set by government agencies. They prepare and submit documentation for product approvals, monitor regulations and guidelines, and communicate with regulatory agencies. This role often involves working closely with other departments like research, quality assurance, and manufacturing to gather necessary data and ensure compliance. As an intermediate-level position, a Regulatory Affairs Associate II may also help train junior staff and manage multiple regulatory submissions simultaneously.

What are the key skills and qualifications needed to thrive as a Regulatory Affairs Associate II?

To thrive as a Regulatory Affairs Associate II, you need a strong understanding of regulatory guidelines, scientific or technical documentation, and usually a degree in life sciences or a related field. Familiarity with submission management systems, regulatory tracking databases, and knowledge of FDA, EMA, or other global regulatory requirements are typically required. Attention to detail, effective communication, and strong organizational skills help you stand out in this role. These abilities ensure accurate submissions, compliance with regulations, and effective collaboration with internal and external stakeholders.

What are some common challenges faced by Regulatory Affairs Associate II professionals when managing submissions for multiple products?

Regulatory Affairs Associate II professionals often manage submissions for several products simultaneously, which can be challenging due to varying regulatory requirements across regions and tight deadlines. They must stay organized, prioritize tasks effectively, and communicate frequently with cross-functional teams such as R&D, quality assurance, and clinical affairs. Navigating changing regulations and ensuring documentation accuracy are also key challenges. Developing strong project management skills and maintaining detailed records can help address these demands.

What is the difference between Regulatory Affairs Associate II vs Regulatory Affairs Specialist?

AspectRegulatory Affairs Associate IIRegulatory Affairs Specialist
CredentialsBachelor's degree, often in life sciences; some certificationsBachelor's or higher in life sciences; certifications like RAC beneficial
Work EnvironmentSupportive team, corporate or pharmaceutical settingsSimilar environment, often more focused on compliance and submissions
Employer & IndustryPharmaceutical, biotech, medical device companiesPharmaceutical, biotech, medical device companies
Search & Comparison IntentUnderstanding entry-level or mid-level roles in regulatory affairsClarifying responsibilities and qualifications of regulatory roles

The Regulatory Affairs Associate II and Regulatory Affairs Specialist roles are similar, both requiring a background in life sciences and industry experience. The Associate II typically supports regulatory submissions and documentation, while the Specialist may take on more complex compliance tasks. Both roles are common in pharmaceutical and biotech companies, with overlapping responsibilities and work environments.

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Regulatory Affairs Associate Ii jobs near you
Infographic showing various Regulatory Affairs Associate Ii 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 - II

Foster City, CA • On-site

Fladger Associates
See more jobs at Fladger Associatesexternal

Contractor

Re-posted 20 days ago

Job description

Foster City, CA
Contract Duration: 12-18 months
Rate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a Regulatory Affairs Associate II in the Foster City, CA area. (Onsite Role)
  • Contractor must meet the company site requirements for the COVID Vaccination PRIOR to starting role
  • Responsible for the preparation of Drug Listings/Lot Distribution Reports (Biologics)
  • Responsible for compiling documentation and sending Certificate of Pharmaceutical Product (CPP) requests to FDA
  • Manage Notarizations (CA licensed notary public a plus), Legalization/apostille of regulatory documents
  • Assist in documentation and signature preparation for:
    • License renewals
    • Establishment registration
  • Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs and work instructions and direction of a senior Regulatory Affairs professional.
  • Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory Affairs CMC department.
  • Seeks assistance from appropriate internal and external resources.
  • Participates in preparing regulatory submissions under direction of a senior Regulatory Affairs Professional which require some interactions with other members in the Regulatory department for investigational and commercial products in line with US and ICH requirements, regional requirements and scientific and company policies and procedures.
  • Works to develop and acquire required regulatory skills and knowledge, with guidance from immediate supervisor.
  • Assist with miscellaneous US RA CMC team-related administrative documents/activities such as processing of invoices.
  • Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity and seeks assistance from appropriate internal and external resources.

Experience:

  • A Bachelor's Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment, OR 1+ years relevant training or industry experience preferably in GMP environment with advanced degree.
  • Must work well under deadlines and have excellent attention to detail.
  • Strong computer and organizational skills required.
  • Excellent verbal and written communication skills and interpersonal skills are required.
  • Preferred:
    • Degree in a relevant Scientific field
    • Relevant Regulatory CMC submission experience