Responsible for managing CMC regulatory activities that support the develeopment of company proprietary products and partnered programs. Develops and ensures implementation of CMC regulatory strategies and tactics for earliest possible approvals of INDs/CTAs for drugs to start clinical trials and generation of CMC data to meet requlatory reuirements for NDA/MAA filings and approvals. 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 primary CMC regulatory contact to respond to reagulatory agency questions on proprietary products. Also serves as principal Company regulatory CMC contact on partner programs and at partnered meetings with regulatory agencies. 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.

Has primary responsibility for coordinating the strategy, preparation of drafts, edits, review and submission of the CMC section regulatory dossiers in support of the development of new drug products and partnered programs in the US and ex-US countries (e.g., IND, NDA, CTD, CTA, IMPD, MAA, Drug Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc.). Works with project teams and department management to develop regulatory strategies, to proactively identify and address regulatory risks, and enable earliest possible approval of INDs/CTAs for start-up of clinical trials and generation of CMC data for NDA/MAA filings and approvals. Ensures that submissions meet format and content requirements applicable to specific health authority regulatory requirements (i.e., US, EU , ICH, and ROW). Functions as primary CMC regulatory contact for project related interactions with US and Ex-US regulatory agencies for partner and internal programs. Serves as principle CMC regulatory contact with partnered programs, and contract manufacturers. 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. 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' SOPs needs; 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. Develops, maintains, and manages timelines for regulatory submissions, and department initiatives to support company goals. 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 regards 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.