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Pharmaceutical Regulatory Jobs (NOW HIRING)

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Staff Pharmacist

Brooklyn, NY · On-site

$85K - $90K/yr

Ensure pharmaceutical regulatory compliance by staying current with drug regulation policies, HIPAA guidelines, and pharmacy practice standards Skills: * Demonstrated ability to practice as a ...

Some portion may include relevant exposure to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Proven 3+ years in a strategic leadership role with strong project ...

Some portion may include relevant exposure to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Proven 3+ years in a strategic leadership role with strong project ...

Director, RA Global Regulatory Strategy

Irvine, CA · On-site

$161K - $212K/yr

Some portion may include relevant exposure to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Proven 3+ years in a strategic leadership role with strong project ...

... pharmaceutical regulatory affairs (mandatory) Attention to detail Excellent oral and written ... communication skills Knowledge of US drug regulatory requirements (mandatory) REQUIRED BS or MS in ...

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Pharmaceutical Regulatory information

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$39

$62

How much do pharmaceutical regulatory jobs pay per hour?

As of Aug 8, 2026, the average hourly pay for pharmaceutical regulatory 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 pharmaceutical regulatory?

Pharmaceutical regulatory affairs is a specialized field focused on ensuring that pharmaceutical products comply with all regulations and laws governing their development, approval, manufacturing, and distribution. Professionals in this area work closely with health authorities, such as the FDA or EMA, to prepare and submit documentation, oversee clinical trial compliance, and maintain ongoing product registrations. Their goal is to ensure that medicines are safe, effective, and meet all legal requirements before reaching the market.

What are the key skills and qualifications needed to thrive in pharmaceutical regulatory?

To thrive in Pharmaceutical Regulatory, you need a strong understanding of regulatory guidelines, drug development processes, and compliance, typically supported by a degree in pharmacy, life sciences, or a related field. Familiarity with regulatory submission systems (such as eCTD), document management tools, and certifications like RAC (Regulatory Affairs Certification) are highly valued. Attention to detail, effective communication, and problem-solving skills help professionals navigate complex regulations and collaborate with cross-functional teams. These skills ensure that pharmaceutical products meet legal requirements and reach the market efficiently and safely.

Is pharmaceutical regulatory affairs a good career?

Pharmaceutical regulatory affairs is a stable and growing field that involves ensuring drug compliance with government regulations, often requiring knowledge of laws, documentation, and communication with regulatory agencies. It offers opportunities for specialization, career advancement, and work in a highly regulated industry. Success in this field typically depends on relevant education, certifications, and strong attention to detail.

What is the difference between Pharmaceutical Regulatory vs Pharmaceutical Quality Assurance?

AspectPharmaceutical RegulatoryPharmaceutical Quality Assurance
Primary FocusEnsuring compliance with regulations and managing submissions to authoritiesMaintaining product quality through processes, audits, and standards
Required CredentialsRegulatory affairs certifications, life sciences degreeQuality assurance certifications, GMP training
Work EnvironmentRegulatory agencies, pharmaceutical companies, documentationManufacturing sites, quality labs, validation teams
Industry UsageRegulatory submissions, compliance monitoringProduct testing, process validation, quality control

Both roles are essential in the pharmaceutical industry, with Regulatory focusing on compliance and submissions, while Quality Assurance emphasizes product quality and process integrity. Professionals often collaborate to ensure products meet legal standards and quality expectations.

What are some common challenges faced by professionals in pharmaceutical regulatory roles, and how can they be managed?

Pharmaceutical regulatory professionals frequently navigate complex and evolving regulations across different markets, which can pose challenges in keeping submissions accurate and compliant. Staying current with international guidelines, coordinating with cross-functional teams, and managing tight deadlines are routine aspects of the job. To manage these challenges, professionals often rely on ongoing training, strong organizational skills, and effective communication with both internal stakeholders and regulatory authorities. Building a network within the regulatory community also helps in staying informed about best practices and regulatory updates.
More about Pharmaceutical Regulatory jobs
What cities are hiring for Pharmaceutical Regulatory jobs? Cities with the most Pharmaceutical Regulatory job openings:
What states have the most Pharmaceutical Regulatory jobs? States with the most job openings for Pharmaceutical Regulatory jobs include:
Infographic showing various Pharmaceutical Regulatory job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 9% Part Time, and 4% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

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Re-posted 16 days ago


Job description

Description: 

Key Responsibilities:

1. Provide strategic input and technical guidance on regulatory requirements to R&D project teams. 

2. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. 3. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high quality submissions. 

4. Monitor product-related activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices. 5. Review all supporting documentation required in regulatory applications for accuracy and completeness and determine the applicability of supporting documentation for inclusion in regulatory submission. 

6. Keep abreast of additions, changes, and emerging trends to regulations and guidelines and evaluate relevance to company and products.

 7. Provide the regulatory perspective on Due Diligence activities in support of potential new business opportunities. Review data/information as needed. 

8. Be familiar with Global regulatory aspects of all the global products; contribute to discussions and regulatory strategies as needed. 9. Establish expertise on guidelines and regulatory requirements for combination products. 

10. Ensure the maintenance of FDA Controlled Correspondences log in an easily searchable format to enable quick reference to resolved issues. 

11. Ensure the maintenance of FDA Information Requests log for A/NDAs in an easily searchable format to provide insight into FDA review trends.

 12. Review and oversee the development and/or revision of Standard Operation Procedures as they relate to cGMP quality and regulatory compliance. 

Required Education and Experience: 

  •  BS/BA required in a scientific discipline. 
  •  Minimum of 12 years of experience in the pharmaceutical/biotech industry within the Regulatory Affairs/R&D functions. 
  •  Deep and broad knowledge of regulatory affairs. 
  •  Direct, hands-on experience with pharmaceutical regulatory submissions and product • approvals.
  •  Experience with post-approval life cycle management of marketed products. 
  •  Proven track record of effective collaboration with regulatory agencies, including the FDA 
  •  Solid knowledge of cGMP regulations and current industry trends related to pharmaceutical and biological products. 
  •  Thorough understanding of the applicable sections of the US Code of Federal Regulations, FDA/ICH guidelines and cGMP''s, as they pertain to pharmaceuticals. 
  •  Advanced degree in a scientific discipline preferred 
  •  Must be able to serve as the company expert on regulatory affairs.
  •   Strong entrepreneurial abilities, sense of urgency, and team player. 
  •  Well-developed organizational, interpersonal, and project management skills. 
  •  Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions. 
  •  Experience with combination products. 
  •  Excellent written and verbal communication required.
  •  Must be willing to travel.