Global Regulatory Affairs

• Develop regulatory strategies for preclinical through Phase IV programs
• Develop, write, compile and review regulatory documents including: IND, NDA, BLA, ANDA, IDE, PMA, 510(k), CTA, IMPD, CTD, MAA and DMF
• Review submissions for verification of compliance with applicable guidelines and for potential refusal-to-file issues
• Provide support for meetings with regulatory authorities: includes preparation of briefing documents, attending meetings and interaction with regulatory authorities on behalf of clients
• Interpretation of ICH, FDA and European Medicines Agency (EMA) regulations and guidance
• Preparation and submission of annual reports and maintenance of regulatory submissions