1001 Durham Ave South Plainfield, NJ 07080 | 908.941.5456

Regulatory Affairs Manager

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Title: Manager Regulatory Affairs
Position Type: Full-time
FLSA Status: Exempt
Location:                  Piscataway, NJ & Laurelton, NY
Department: Regulatory Department
Effective Date: Immediately




PuraCap Pharmaceutical LLC. is a fast growing New Jersey based private-hold pharmaceutical company, who has operations globally. PuraCap Pharmaceutical LLC develops, manufactures and supplies pharmaceutical products to the healthcare industry in US and worldwide market, including but not limited to prescription drugs, OTC drugs, and personal care products.


Regulatory Affairs Manager provides strategic and operational regulatory direction and documentation for projects / products covering product development, registration and approval / post approval activities for ANDAs/NDAs. This individual will oversee the regulation process for products requiring regulatory approval, including filing necessary applications and handling all interactions with regulatory authorities. This candidate must have excellent written and effective verbal communication skills, proficient in project management, is a flexible individual and able to work in a fast paced environment. This role is Exempt and is not eligible for overtime.



  • Actively contributes to the development and implementation of regulatory strategy for assigned projects.
  • Translate regulatory requirements into practical workable submission plans
  • Provide accurate comments during document review
  • Monitor company progress towards fulfillment of regulatory commitments
  • Review and communicate emerging regulatory requirements to ensure compliance
  • Act as a liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross functional meetings
  • Interface with external regulatory groups and regulatory agencies
  • Prepare, coordinate, manage regulatory submissions (e.g. ANDA, NDA, 510K, CMC, CTAs, amendments, supplements, safety reports, annual reports, etc.) in accordance with applicable regulations;
  • Manage direct reports



Additional Skills/Knowledge:
  • Knowledge understanding of US and International drug filing regulations
  • Detail oriented
  • Able to handle multiple projects with good prioritization skills
  • Strong written and verbal communication skills.
  • Previous managerial experience




Report To:  Sr. Director of Regulatory & Quality




  • BS in Pharmacy, Chemistry, or a related discipline
  • 5+ years experience in pharmaceutical regulatory affairs is required,
  • Experience in Generic Regulatory filings preferred



  • Laboratory and office environment
  • Ability to sit for long periods of time as required




Email cover letter with resume humanresources@puracap.com and in email subject include:  “Regulatory Affairs Manager”


PuraCap Pharmaceutical LLC is an equal opportunity employer and affords equal opportunity to all applicants and employees for all positions without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws.


If interested in applying for any of the above positions at PuraCap, please send your Resume / CV to humanresources@puracap.com