Manager, Analytical Filings & Regulatory Affairs

  • Responsible for pre & post approval submission activities incl. submissions of ANDAs, Supplements & Annual Reports in eCTD format; prepare/review CMC submission documents from regulatory perspective to meet scientific & technical requirements for acceptability & approvability by FDA; review quality documentation for regulatory submissions & inspections; review product complaints, adverse event reports & prepare documentation/submissions to appropriate regulatory agencies as necessary; propose/develop new chemical or intermediate specifications or modify existing specifications to meet FDA requirements; establish/ maintain procedures for work instructions, & other forms as needed to meet quality system requirements; draft/develop appropriate label documentation & labeling formats in support of new ANDAs; review/revise current labels and labeling of approved products in compliance with the RLDs; maintain current knowledge base of existing and emerging regulations, standards or guidance documents. 

     REQ.:  Master’s Degree or foreign educ. equiv. in Pharmaceutical Sciences, Pharmacy or Chemistry & 2 years of pharmaceutical experience in pharmaceutical QA/AC and/ or Regulatory & solid oral dosage forms is required.  Experience with regulatory submission/ approval process, writing regulatory documents & technical reports for regulatory submissions is also required. 

     APPLY:  Resumes may be uploaded via our website by visiting www.cadista.com & clicking on “Join Our Team”.  Jubilant Cadista Pharmaceuticals Inc., 207 Kiley Dr., Salisbury, Maryland 21801.