Regulatory Operations Senior Manager
4 weeks ago
We are currently seeking a Senior Manager of Regulatory Operations. Within the role you will:
Develop and execute novel drug regulatory strategy
Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines
Establish sound regulatory advice/position on key development issues, and communicate same to the respective stakeholders
Provide a high-level review of client programs and develop strategic plans for clinical, analytical, and process development
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
Initiate, author, and/or collaborate on SOP’s, work instructions and Work Flows for the regulatory operations function. e.g. electronic Common Technical Document (eCTD) Investigational and Marketing Applications, and post-marketing compliance maintenance submissions in the United States, Europe, and RoW
Author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and associated messaging
Work closely with the development team to ensure overall regulatory strategy, regulatory CMC strategy, and labeling strategy for Pharmaceutical/Biological products are aligned
Be the point of contact between the company and the regulatory agency – serve as the regulatory liaison
Help strategize a road map for EU expansion: MAA planning (Type of submissions – DCP, CP, NP, MRP, Country(ies) selection for MAA and for being CMS vs. RMS and Inputs to set up EU QPPV Office
Desirable Skills and Experience
10 – 15 years’ experience working in a regulated, life science environment
Good interpersonal skills
Experience in defining organizational strategy, process and change management, KPIs and metrics, resource forecasting
Extensive knowledge of global submission standards, including but not limited to FDA, HC, EMA, ICH, eCTD and industry trends for dossier preparation (IND/CTA/NDA/MAA/NDA) and regulatory change management and operations.
Knowledge on RoW markets is a plus
Experience in medical device regulations is a plus
Knowledge of eCTD publishing systems, TRS toolbox, and related tools
Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
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