1001 Durham Ave South Plainfield, NJ 07080 | 908.941.5456

Sr Regulatory Affairs Specialist

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Title: Sr Regulatory Affairs Specialist
Position Type: Full-time
FLSA Status: Exempt
Location:                  Piscataway, NJ
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 Sr Associate will review and prepare regulatory documents related to ANDA/ANDA submissions.   Prepares submissions for projects / products covering product development, registration, approval and post approval activities for ANDAs/NDAs. This individual will be part of project teams, provide Regulatory insight and direction.  Review and compile Regulatory submissions.  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.




  • Author and compile Regulatory filings including new ANDA/NDA submissions, Amendments, Supplements, Annual Reports, Safety Reports
  • Review all source documentation for scientific and regulatory requirements
  • 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



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





Report To:  Regulatory Affairs Manager




  • BS in Pharmacy, Chemistry, or a related discipline
  • 2-3 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:  “Sr Regulatory Affairs Specialist”


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