Regulatory Operations Senior Manager

4 weeks ago

Princeton, United States CareerBuilder Full time

Job Description
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
* Strong project management skills
* Good interpersonal skills
* Business development 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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