Regulatory Affairs Specialist
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At a glance
Requirements
Credentials this posting asks for.
Job overview
Pioneer Life Sciences LLC is hiring a Regulatory Affairs Specialist. The Regulatory Affairs Specialist reviews, compiles, and submits regulatory documents for pharmacovigilance and safety reporting to the FDA, supports clinical and drug development activities, prepares IND and NDA submissions, analyzes reference listed drugs and patent updates, coordinates ANDA filings, maintains product datasheets and ADR databases, and ensures timely CAPA and complaint closure in compliance with GMP.
Key focus areas include Review, compile, and submit regulatory documents for pharmacovigilance and safety reporting to the FDA, Support clinical and drug development activities, including preparation and review of IND and NDA applications, and Review and analyze Reference Listed Drugs and the Orange Book for patent law updates and regulatory changes.
Important skills include Patent Law, FDA Inspections, Clinical Development, Drug Development, IND Applications, and NDA Applications.
Skills & qualifications
Skills
Qualifications
Full job description
Experience Required
0
Minimum Education Required
Master’s Degree in Pharmaceutical Science, Drug Regulatory Affairs, or Chemistry
License(s) Required
0
Compensation
$84,800.00 - $88,000.00 / Yearly
Hours Per Week
40
Number Of Positions
1
Shift
First Shift (Day)
Job Description
Regulatory Affairs Specialist (East Brunswick, NJ)- Review, compile, and submit regulatory documents for Pharmacovigilance and safety reporting to the FDA, ensuring compliance with post-marketing requirements for both prescription and OTC pharmaceutical products; Support clinical development and overall drug development activities, including the preparation and review of regulatory submissions including IND and NDA applications; Review and analyze Reference Listed Drugs (RLD) and the Orange Book for patent law updates and regulatory changes; Prepare, coordinate, and support ANDA filings (GPI, GIL) accordance with current FDA requirements and Good Manufacturing Practices (GMP); Maintain pharmaceutical product datasheets and documentation to support internal audits and FDA inspections; Maintain adverse drug reaction (ADR) complaint databases for both prescription and OTC products; Ensure timely completion of CAPA, trend analysis, complaint closure, and consumer communication in compliance with regulatory and GMP requirements. Must have a Master’s Degree in Pharmaceutical Science, Drug Regulatory Affairs, or Chemistry plus skills and knowledge in Patent Law, FDA Inspections, Clinical development / Drug Development / IND / NDA, OTC, Orange Book, GMP. Standard company benefits with $84.8k~$88k/year. Send resume with job code AKP002 to HR, Pioneer Life Sciences at 40E Cotters Ln, East Brunswick, NJ 08816.
Place of Work
On-site
Requisition ID
AKP002
Job Type
Full Time
Application Instructions
Send resume with job code AKP002 to HR, Pioneer Life Sciences at 40E Cotters Ln, East Brunswick, NJ 08816.
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