Basking Ridge, NJ
Industry: Pharmaceuticals & Biotech•
8 - 10 years
Posted 61 days ago
This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad hoc member to the Global Project Team for late stage projects. This position manages multiple biological developmental and post marketing projects with supervision, including 3rd party developments.
This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (e.g., IND, IMPD, IB) and marketing applications/supplements & variations (e.g., NDA, BLA, MAA).
This position authors regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this position acts as the company liaison with the Health Authority (e.g., US FDA and EU EMA) for assigned projects with support, on CMC matters.
This position supports Health Authority Meetings (e.g., preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing book, to training and preparing the technical team, to authoring and finalizing the meeting minutes.
This position develops awareness of global requirements through support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence, regulatory authority inspections).
Additionally, this position has direct interaction with research laboratory members, the Contract Sales Organization (CSO), Labeling members and Clinical members. This position works with non-standard problems of some complexity. This position makes decisions with consultation.
Education and Experience: