Responsible for supporting the Regulatory Affairs Department across a number of company-sponsored projects. Under supervision, has primary responsibility for assembling regulatory dossiers for review by senior regulatory affairs management. 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 extremely complex problems in which analysis of data require an evaluation of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. Under the direction of senior regulatory affairs staff, compiles and prepares regulatory submissions for Company and partner sponsored global regulatory submissions, including 510(K), IDE, IND, NDA, CTD, CTA, IMPD, MAA, Drug/Device Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc.. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Reviews methods, SOPs, protocols, reports for regulatory compliance and reports findings to senior regulatory affairs staff. Maintains formal and one-one training to become familiar with relevant laws, regulations and guidelines governing drug or device development and approval. Reviews Federal Register for relevant information covering new government policies and guidelines for distribution to the Regulatory Affairs Department. Under the direction of senior regulatory affairs staff, prepares departmental special reports, white papers, etc.. Maintains regulatory submissions and correspondence for Company sponsored projects, and all company related sections for partner sponsored projects. Under the direction of senior regulatory affairs staff, maintains state Drug and Device Manufacturing licenses and monitors status of California Board of Pharmacy exempt certificates. Under the direction of senior regulatory affairs staff, develops timelines for submissions. Follows general instructions to complete projects. Organizes workday to complete mid-term assignments. Supports other projects as needed, which will include but not be limited to performing research and compiling materials to develop regulatory strategies. May supervise the activities of junior regulatory affairs staff.