Manager, Regulatory Affairs Strategy - Immunology & Inflammation

Job description

The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. A typical day might include the following: Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure Assist in coordination and preparation for Agency meetings and associated briefing document preparation Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/m...