Associate Director Regulatory Affairs
Camden Metro Area, NJ
- PhD preferred - Scientific Discipline
- At least 5 years of regulatory experience including advanced hands on training in NDA submissions for FDA Approval
- Expertise in ICH , FDA and EU and other major regulatory systems
- Experience with various types of US submissions - solid dosage forms preferred.
- Experience working and communicating with the FDA, including coordinating and managing meetings for
- Familiarity with clinical trials
- Module 1 documents for US NDA, sNDA labeling supplements, etc.
- Remain current on Regulatory Intelligence, new guidance documents
- Contribute the US regulatory perspective as required
- Collaborate closely with external partners for regulatory considerations, strategy and key regulatory documents