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Regulatory Associate Jobs in Basking Ridge, NJ (NOW HIRING)

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Bank Regulatory

Manhattan, NY

A top ranked bank regulatory practice is seeking to add an associate with 3+ years of experience to its team. The ideal candidate will have knowledge of relevant regulations including the Volcker ...

MSD

Assoc. Dir, Regulatory Affairs-CMC

Rahway, NJ

Associate Principal Scientist, Regulatory CMC Digital Innovation Rahway, NJ or West Point, PA Our Company is a global health care leader with a diversified portfolio of prescription medicines ...

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Regulatory Associate information

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$17

$33

$50

How much do regulatory associate jobs pay per hour?

As of Sep 3, 2026, the average hourly pay for regulatory associate in Basking Ridge, NJ is $33.19, according to ZipRecruiter salary data. Most workers in this role earn between $25.29 and $39.38 per hour, depending on experience, location, and employer.

What does a regulatory associate do?

As a regulatory associate or regulatory affairs associate, your job is to coordinate compliance with internal—and occasionally external—regulations. This work involves checking each inspection review for accuracy, using safety data sheets (SDS), gathering and compiling documentation for products, and submitting material for license renewals and registrations. In this role, you often create management templates, study existing report documents, oversee the collection of consent forms, and audit the company for any sign of regulatory noncompliance. Some regulatory associates frequently travel to perform audits at various locations. Depending on the industry, you may have additional tasks that involve meeting state or federal guidelines.

What are the key skills and qualifications needed to thrive as a regulatory associate, and why are they important?

To thrive as a Regulatory Associate, you need strong attention to detail, knowledge of regulatory guidelines (such as FDA or EMA), and a relevant degree in life sciences or a related field. Familiarity with regulatory submission systems, document management tools, and electronic common technical document (eCTD) software is typically required. Excellent organizational skills, communication abilities, and the capacity to manage deadlines make candidates stand out. These skills ensure accurate regulatory submissions, compliance with evolving regulations, and effective collaboration across teams, all of which are crucial for product approvals and market access.

What are some common challenges regulatory associates face when working with cross-functional teams?

Regulatory Associates often work closely with teams from R&D, quality assurance, clinical, and legal departments to ensure compliance throughout product development and approval processes. A common challenge is navigating differing priorities and timelines among these groups, which requires strong communication and organizational skills. Additionally, Regulatory Associates must interpret and clarify complex regulatory requirements to various stakeholders, ensuring everyone is aligned and informed. Building collaborative relationships and proactively addressing potential misunderstandings are key to overcoming these challenges.

What is the difference between Regulatory Associate vs Compliance Specialist?

AspectRegulatory AssociateCompliance Specialist
Required CredentialsBachelor's degree in life sciences, regulatory affairs, or related field; certifications like RAC are a plusBachelor's degree in law, business, or related; certifications like CCEP may be relevant
Work EnvironmentPharmaceutical, biotech, or medical device companies; regulatory departmentsCorporate compliance departments across various industries, including healthcare and finance
Employer & Industry UsageUsed in regulated industries to prepare and submit regulatory documentsUsed to ensure company adherence to laws and regulations, often involving audits and policy development

The Regulatory Associate primarily focuses on preparing and managing regulatory submissions within life sciences industries, while the Compliance Specialist ensures ongoing adherence to laws and regulations across various sectors. Both roles require similar educational backgrounds and certifications, but their core responsibilities and work environments differ slightly, with Regulatory Associates working more directly with regulatory agencies and Compliance Specialists focusing on internal compliance processes.

Is regulatory associate high paying?

Regulatory associates typically earn a competitive salary that varies by industry, location, and experience level. In general, the role offers moderate to high pay, especially for those with specialized knowledge of regulations, certifications, or experience in highly regulated sectors like pharmaceuticals or healthcare.
More about Regulatory Associate jobs

What are the most commonly searched types of Regulatory jobs in Basking Ridge, NJ?

The most popular types of Regulatory jobs in Basking Ridge, NJ are:

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For Regulatory Associate jobs in Basking Ridge, NJ, the most frequently searched job titles are:

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Cities near Basking Ridge, NJ with the most Regulatory Associate job openings:

Regulatory Associate jobs near you
Infographic showing various Regulatory Associate job openings in Basking Ridge, NJ as of August 2026, with employment types broken down into 1% As Needed, 71% Full Time, 25% Part Time, 1% Temporary, and 2% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $69,039 per year, or $33.2 per hour.

Senior Associate, Regulatory Operations

Breckenridge Pharmaceutical Inc

Berkeley Heights, NJ • On-site

$115 - $135/hr

Other

Medical, Dental, Vision, Retirement

Re-posted 8 days ago

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Associate, Regulatory Operations

Full Time Professional Berkeley Heights, NJ, US

6 days ago Requisition ID: 1024

Salary Range: $115,000.00 To $135,000.00 Annually

About the jobAbout the Company

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

Responsibilities
  • Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time in accordance with eCTD submission requirements.
  • Works with the Manager as well as document authors or leads across all disciplines to develop and maintain a comprehensive set of e-submission document templates that are fully compliant with FDA and ICH document requirements.
  • Maintains efficient tracking mechanisms for all regulatory information including the archiving and storage of both electronic and hard copy records.
  • Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.
  • Assists in monitoring and maintains familiarity with evolving and/or new regulatory e-submission requirements and under the direction of the Manager of Regulatory Operations, ensures that all functional disciplines are apprised of the changes and trained accordingly.
  • Helps to author, develop and/or collaborate on SOPs and Work Instructions for the eCTD Publishing and/or Electronic Document Management System.
  • Independently track and manage all correspondence between Breckenridge and government agencies, including phone calls, emails, and relevant documents.
  • Accurately update and maintain trackers, spreadsheets and databases in a timely manner.
  • Meticulously meets corporate and departmental filing objectives with strict adherence to FDA/ICH requirements.
  • Monitors and maintains the highest level of eCTD submission standards.
  • Trains new employees in company submission processes and procedures.
  • Performs other related duties as assigned.
Qualifications
  • Bachelor’s degree in a scientific discipline.
Required Skills
  • Minimum 5 years’ experience in the Pharmaceutical Industry with 3-4 years’ in drug regulatory affairs operations.
  • Knowledge of eCTD publishing systems and standards, EDMS technology and related publishing tools.
  • Working knowledge of US FDA (OGD/CDER) e-submission requirements.
  • Strong written and verbal communication skills.
  • Computer skills required: Microsoft Word, Adobe Acrobat, Microsoft Office Suite, and eCTD publishing software.
Pay range and compensation package

At Breckenridge Pharmaceutical, Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location:

  • Flexible approach to how we work
  • Health benefits and time-off programs
  • Competitive compensation packages
  • The anticipated annual salary for this role is $115,000 - 135,000
Equal Opportunity Statement

Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Featured benefits

Medical insurance, Vision insurance, Dental insurance, 401(k), Student loan assistance

Requirements added by the job poster
  • 3+ years of work experience with Generic Drugs
  • 3+ years of work experience with Electronic Common Technical Document (eCTD)
  • 3+ years of work experience with Abbreviated New Drug Application (ANDA)
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