Regulatory Specialist
Rosemont, IL · On-site
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 ...
Rosemont, IL · On-site
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 ...
Rosemont, IL · On-site
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 ...
Berkeley Heights, NJ · On-site
$90K - $125K/yr
Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective ... About the Role The Regulatory Affairs Senior Associate is responsible for managing key regulatory ...
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Berkeley Heights, NJ · On-site
$90K - $125K/yr
Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective ... About the Role The Regulatory Affairs Senior Associate is responsible for managing key regulatory ...
Must have a minimum of 6 years of experience in pharmaceutical regulatory affairs specializing in Advertising and Promotion. * Bachelor's degree required; Advanced degree in a science discipline ...
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Must have a minimum of 6 years of experience in pharmaceutical regulatory affairs specializing in Advertising and Promotion. * Bachelor's degree required; Advanced degree in a science discipline ...
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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 ...
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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 ...
$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 ...
$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 ...
Irvine, CA · On-site
$160K/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 ...
Irvine, CA · On-site
$160K/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 ...
$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 ...
$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 ...
North Chicago, IL · On-site
$144K - $190K/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 ...
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North Chicago, IL · On-site
$144K - $190K/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 ...
Qualifications: · Must have a minimum of 4 years of experience in pharmaceutical regulatory affairs specializing in Labeling Strategy. · Bachelor's degree required; Advanced degree in a science ...
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Qualifications: · Must have a minimum of 4 years of experience in pharmaceutical regulatory affairs specializing in Labeling Strategy. · Bachelor's degree required; Advanced degree in a science ...
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 ...
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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 ...
North Chicago, IL · On-site
$160K/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 ...
North Chicago, IL · On-site
$160K/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 ...
Boca Raton, FL · On-site
$100 - $130/hr
Bachelor's degree in Pharmaceutical, Biological, Chemical Science or related field. Advanced degree desirable. * Experience Requirements: * Minimum of 7 years of practical pharmaceutical regulatory ...
New
Boca Raton, FL · On-site
$100 - $130/hr
Bachelor's degree in Pharmaceutical, Biological, Chemical Science or related field. Advanced degree desirable. * Experience Requirements: * Minimum of 7 years of practical pharmaceutical regulatory ...
New
Lansing, MI · Remote
$143K - $238K/yr
Maintain and continuously improve the Pharmaceutical Quality Management System (QMS), ensuring ... Collaborate with regulatory agencies and cross-functional teams to support submissions, regulatory ...
New
Lansing, MI · Remote
$143K - $238K/yr
Maintain and continuously improve the Pharmaceutical Quality Management System (QMS), ensuring ... Collaborate with regulatory agencies and cross-functional teams to support submissions, regulatory ...
New
Lansing, MI · On-site +1
$143K - $238K/yr
Maintain and continuously improve the Pharmaceutical Quality Management System (QMS), ensuring ... Collaborate with regulatory agencies and cross-functional teams to support submissions, regulatory ...
Lansing, MI · On-site +1
$143K - $238K/yr
Maintain and continuously improve the Pharmaceutical Quality Management System (QMS), ensuring ... Collaborate with regulatory agencies and cross-functional teams to support submissions, regulatory ...
Qualifications QUALIFICATIONS BS or MS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy 1 - 2 years' experience in pharmaceutical regulatory affairs (mandatory) Attention ...
Qualifications QUALIFICATIONS BS or MS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy 1 - 2 years' experience in pharmaceutical regulatory affairs (mandatory) Attention ...
... 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 ...
... 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 ...
Camarillo, CA · On-site
$90K - $100K/yr
S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they ... Job Summary The Senior Regulatory Compliance Specialist is responsible for ensuring that our ...
Camarillo, CA · On-site
$90K - $100K/yr
S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they ... Job Summary The Senior Regulatory Compliance Specialist is responsible for ensuring that our ...
BA/BS in a scientific discipline - Chemistry or Biology are preferred Master s Degree a plus 4+ years of pharmaceutical regulatory affairs experience Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or ...
BA/BS in a scientific discipline - Chemistry or Biology are preferred Master s Degree a plus 4+ years of pharmaceutical regulatory affairs experience Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or ...
QUALIFICATIONS BS or MS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy 1 - 2 years' experience in pharmaceutical regulatory affairs (mandatory) Attention to detail ...
QUALIFICATIONS BS or MS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy 1 - 2 years' experience in pharmaceutical regulatory affairs (mandatory) Attention to detail ...
... of pharmaceutical regulatory affairs experience Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or IND submissions experience Expertise with Microsoft Office Suite, Electronic Document Management ...
... of pharmaceutical regulatory affairs experience Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or IND submissions experience Expertise with Microsoft Office Suite, Electronic Document Management ...
$18.99 - $22.95
3% of jobs
$22.95 - $26.90
6% of jobs
$26.90 - $30.86
13% of jobs
$31.38 is the 25th percentile. Wages below this are outliers.
$30.86 - $34.81
20% of jobs
The median wage is $36.35 / hr.
$34.81 - $38.77
19% of jobs
$38.77 - $42.72
9% of jobs
$44.70 is the 75th percentile. Wages above this are outliers.
$42.72 - $46.68
10% of jobs
$46.68 - $50.63
6% of jobs
$50.63 - $54.59
5% of jobs
$54.59 - $58.54
5% of jobs
$58.54 - $62.50
3% of jobs
$18
$39
$62
| Aspect | Pharmaceutical Regulatory | Pharmaceutical Quality Assurance |
|---|---|---|
| Primary Focus | Ensuring compliance with regulations and managing submissions to authorities | Maintaining product quality through processes, audits, and standards |
| Required Credentials | Regulatory affairs certifications, life sciences degree | Quality assurance certifications, GMP training |
| Work Environment | Regulatory agencies, pharmaceutical companies, documentation | Manufacturing sites, quality labs, validation teams |
| Industry Usage | Regulatory submissions, compliance monitoring | Product 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.

Other
Re-posted 16 days ago
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: