We are seeking an Associate Regulatory Affairs for our North America business. The incumbent will be responsible for maintenance and tracking of regulatory documentation and information pertaining to life cycle management activities; assisting in review of CMC documents for supplements, ANDAs, NDAs, DMFs as needed.
Responsibilities:
- Provide Inputs/review of post approval Changes (Supplements PAS/CBE-30/CBE-0 & Annual Reports) for ANDAs and ensure timeliness and quality of compilation, publishing and submission of post approval changes
- Support with assigned review of CMC documents for assigned new and LCM products
- Support to internal stakeholders and customers on data requests by coordinating with India RA teams and other internal stakeholders
- Assist with due diligence / divestment and gap analysis in consultation with Team Lead
- Review and closure of change notifications (CRNs)/change controls in consultation with Team Lead for under review and launched products
- Providing launch support w.r.t regulatory decisions in consultation with Team Lead
- Facilitate interaction with USFDA to seek clarity around the issues identified during development, review and launch
- Assist with forms and documentation signoff as assigned by Team Lead; handle CDER portal submissions/FOI requests
- Regulatory folder maintenance/archival for assigned products
- Assist and track Establishment Registration, Facility Self-identification, Annual GDUFA fee program, PDUFA Program Fee, Facility Fee
- Assist with Annual volume reporting and Drug Listing for both Drug Substances and Drug Products as per GDUFA
- Regulatory SOP and training activities on an as needed basis