1001 Durham Ave South Plainfield, NJ 07080 | 908.941.5456
PuraCap Pharmaceutical LLC, headquartered in NJ, is a global fully integrated pharmaceutical company with expertise in product development, manufacturing, and bringing affordable, world-class quality products to their customers. The PuraCap corporate structure supports a three-pronged approach for global growth with dedicated companies in the areas of prescription brands (PuraCap Pharmaceutical) as well as prescription generics and OTC and private label brands (PuraCap International LLC). PuraCap continues to innovate using soft gel expertise developing other soft gel and oral solid dosage options.
|Title:||Regulatory Affairs – Operations Associate|
|Department:||Regulatory Affairs Department|
A. POSITION SUMMARY:
PuraCap Pharmaceutical LLC is a fast growing New Jersey based privately-held pharmaceutical company that operates on a global scale. PuraCap Pharmaceutical LLC, develops, manufactures and supplies pharmaceutical products to the healthcare industry in the United States and worldwide market, including but not limited to prescription drugs, OTC drugs, and personal care products.
Regulatory Affairs Operations is responsible for assisting with the preparation, compilation, quality assurance, tracking and delivery of regulatory submissions in accordance with the U.S. Food and Drug Administration’s requirements, company standards, and timelines. Furthermore, this position will assist with eCTD compliance, eCTD lifecycle management, Drug Establishment Registration, Drug Listings, and publishing systems/tools. Candidates must possess strong written and verbal communication skills, proficiency with computers, and is flexible and able to work in a fast-paced office environment. This role is Exempt and is not eligible for overtime.
B. MAJOR DUTIES/RESPONSIBILITIES:
C. ORGANIZATIONAL RELATIONSHIPS:
Report To: Regulatory Affairs Operations Specialist
D. MINIMUM/PREFERRED REQUIREMENTS:
E. PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS:
Email cover letter with resume email@example.com and in email subject include: “Regulatory Affairs – Operations”
Not only is PuraCap an internationally inclusive company, but we embrace and encourage diversity. PuraCap is proud to be an equal opportunity workplace and is an affirmative action employer.