PuraCapRegulatory Affairs – Operations Associate

Company Overview

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.

POSITION DESCRIPTION

Title:	Regulatory Affairs – Operations Associate
Position Type:	Full-time
FLSA Status:	Exempt
Location:	Piscataway, NJ
Department:	Regulatory Affairs Department
Effective Date:	Immediately

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:

Perform document management tasks which include file transfers, storage, tracking and archival of regulatory submissions
Review submission documents to ensure compliance to eCTD requirements
Manage lifecycles of regulatory submissions
Collaborate with Regulatory Affairs and contribute to the creation of submission ready documents that are eCTD compliant
Submission of eCTD compliant submissions through the Electronic Systems Gateway

Additional Skills/Knowledge:

Knowledgeable in eCTD structure/requirements with a firm understanding of US submission types and requirements
Experience in publishing and compilation of eCTD submissions
Strong knowledge of Microsoft Office, Adobe Acrobat, Publishing Tools and Validation Tools
Working knowledge of Extensible Markup Language (.XML)
Able to handle multiple projects with good prioritization skills
Detail oriented
Strong written and verbal communication skills

C. ORGANIZATIONAL RELATIONSHIPS:

Report To: Regulatory Affairs Operations Specialist

D. MINIMUM/PREFERRED REQUIREMENTS:

Education:	Bachelor’s degree preferred; Equivalent experience within Regulatory Affairs Operations will be considered
Experience:	Minimum of 2-3 years of experience in publishing within the pharmaceutical industry Experience in Generic Regulatory eCTD Submissions preferred Ability to read and understand Extensible Markup Language preferred but not required

E. PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS:

Office environment
Ability to sit for long periods of time as required

TO APPLY:

Email cover letter with resume humanresources@puracap.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.