| Global Regulatory Lead, Neuroscience-100% Remote at Remote, Remote, USA |
| Email: [email protected] |
| Hello Friends, I Hope you are doing well. This is Surya from Humac Inc. , Please check the following job description, and if you are interested, or know someone who might be interested, please share your updated resume to reach you. Role: Global Regulatory Lead, Neuroscience Division : Drug Development / Global Regulatory Sciences Functional Area Description: Global Regulatory Strategy Location: Parkway, NJ ( 100% Remote) Job Description: NDA or sNDA experience including labeling negotiation, leading FDA meetings, experience working in psychiatry development of broader neuroscience, understanding of the US FDA, Global Regulatory Team model. Position Summary / Objective Leadership responsibility for global regulatory strategy within a development team (DT) and/or Global Regulatory Team. Position Responsibilities Leadership responsibility for global regulatory strategy within a development team (DT). Serve as team lead or co-lead of marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers. Support the preparation of, and participate in / lead (as appropriate), key Health Authorities (HA) interactions. Assure consistent positions on common issues are presented to the FDA and global HA. Review and approve content of responses to queries from HAs. Prepare content for regulatory strategic documentation and Regulatory Project Reviews. Align regulatory plans with commercial and development plans Develop target labeling and co-lead the cross-functional labeling team. Ensure consistent positions are presented in responses to global health authority (HA) queries. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans. Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs, etc. Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines. Degree Requirements Solid scientific background, Ph.D., M.D., PharmD, MS, or BS -- Best Regards, Sai Surya Teja US IT Recruiter Humac Inc. P: (623)-748-4074 E: [email protected] | W: www.humacinc.com LinkedIn: linkedin.com/in/sai-surya-1b22a721b Phoenix, AZ 85027 Keywords: information technology microsoft Arizona Colorado New Jersey Global Regulatory Lead, Neuroscience-100% Remote [email protected] |
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| Thu Aug 01 18:55:00 UTC 2024 |