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