<p>The Position</p> <p>Reporting to the Executive Director, CMC regulatory, this position will provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development products. This will include the preparation or authoring of CMC regulatory investigational, commercial and post approval submissions, participation in the preparation and execution of health authority interactions, assessing the impact of new regulations, etc. The position will also provide direction and strategical guidance on the interpretation and implementation of global CMC regulations to various sub teams.</p> <p>Responsibilities</p> <ul> <li>Prepare and review submission-ready CMC sections for INDs, CTAs, IND annual reports, IMPD, NDA and MAA applications </li><li>As a member of the project teams, provide CMC regulatory guidance for global development and registration programs (e.g. INDs, CTAs, NDAs and MAAs) </li><li>Assess and communicate CMC regulatory requirements to ensure all development activities are conducted in compliance with applicable regulations and guidelines </li><li>Manage and ensure compliance with all reporting requirements, including annual and periodic reports </li><li>Provide regulatory support and guidance to various departments, programs, and teams with a strong emphasis on frequent interactions with technical teams </li><li>Representing the Regulatory Affairs CMC function on assigned cross-functional project teams. </li><li>Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals </li><li>Research and analyze regulatory information and maintain current regulatory knowledge </li></ul> <p>Requirements:</p> <ul> <li>B.S. in biochemistry, chemistry, biology or related pharmaceutical field </li><li>Minimum of 5 years CMC regulatory affairs experience (or equivalent) </li><li>Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development </li><li>Ability to manage complex projects and timelines in a collaborative matrix team environment </li><li>Excellent analytical skills </li><li>Ability to communicate effectively (verbal and written) to multiple levels in the organization with strong negotiation skills </li><li>Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors </li><li>Demonstrated ability to excel in smaller entrepreneurial organizations </li></ul>