Regulatory Affairs/Quality Assurance Specialist

 

compensation: Based on experience
employment type: full-time

 

Responsibilities:

  • Responsible for the preparation of documents and submissions to the FDA for ANDA's, supplements, amendments. and responses to deficiency letters.
  • Guide and co-operate with company other departments and review and approve activities and documentations from analytical test methods, formulation manufacturing records, packaging masters and labeling in according with FDA regulations.
  • Perform post-market surveillance, assist in risk management assessment and act as liaison with the DEA in all matters pertaining to controlled substances.
  • Assess changes to manufacturing processes and specifications to approved products for appropriate classification.
  • In addition, manage daily/weekly/monthly reports, tasks and projects as required in the Regulatory Affairs Department.

 
Education:

  • Bachelor's Degree required 
  • Master's Degree or PhD Preferred


Requirements:

  • Experience with generic pharmaceutical industry experience required.
  • Experience with FDA interactions and/or other regulatory authorities.
  • Excellent in English speaking, writing and communication skill.
  • Excellent in Microsoft Office softwares.
  • Ability to prioritize and multi­task concurrent project demands.Type your paragraph here.


Interested applicants should send a resume and cover letter to info@pharmulalabs.com