Responsible for managing regulatory activities that support department and company projects and programs. Develops and ensures implementation of strategies and tactics for earliest possible approvals of drug and device filings and applications. Provides regulatory guidance and leadership to company and partner-sponsored project/program teams. Manages internal staff and external resources to ensure quality and timeliness of submissions. Coordinates, prepares, edits and submits responses to regulatory authorities. Serves as principal regulatory contact with corporate partner programs and for the Company at partnered meetings with regulatory agencies; primary regulatory representative to US and ex-US regulatory agencies for routine interactions. May select, develop, and evaluate personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives as well as an understanding of the business. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans and performance requirements. Has primary responsibility for coordinating the preparation of drafts, edits, review and submission of regulatory dossiers in support of investigational and new device and/or drug applications, and post-approval submissions, for US and ROW (e.g., 510(K), IDE, IND, NDA, CTD, CTA, IMPD, MAA, Drug/ Device Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc.). Works with project teams and department management to develop regulatory strategies, identify regulatory risks, and enable earliest possible approval. Ensures that submissions meet format and content requirements applicable to specific health authority regulatory requirements (i.e., US, ICH, and ROW). Provides input on, and reviews specifications, methods, SOPs, protocols, reports, labeling, and etc. for regulatory compliance. Provides direction and requirements to internal staff to ensure high quality output and timely project completion. Ensures that documentation for all projects is maintained and kept current. Identifies Regulatory Affairs' SOP needs and discusses with department. Drafts and reviews Regulatory Affairs' SOPs. Participates in, and provides regulatory guidance, strategy and leadership to working teams (both internal and partnered programs), Project Teams (Core), and Company Management. Serves as principle regulatory contact with corporate partner programs, and contract manufacturers. Develops and maintains timelines for department initiatives and corporate goals. Manages timelines for regulatory submissions. Functions as primary contact for project related interactions with US and Ex-US regulatory agencies for partner and internal programs. Solves problems of significant levels of complexity following established company policies and procedures; informs management of impacts. Works independently to complete assigned projects; keeps management informed on progress. Negotiates, interacts and supervises the activities of contract organizations and consultants in the preparation of regulatory submissions as necessary. Appropriately advises department, project teams and company on issues related to regulatory strategy; identifies areas of concern in regard to developing regulations. Provides input on Regulatory Affairs department activities, including but not limited to; staffing requirements, budget proposal and tracking, regulatory SOPs, training requirements, documentation retention policy and implementation, and etc. May be responsible for conducting performance reviews and providing feedback and coaching to direct reports.