Sr. Regualtory Affairs Specialist
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.
A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 8 years related industry experience is required. A minimum of 4 years hands-on Regulatory Affairs experience is required. Must be able to demonstrate excellent organizational, planning and follow-up skills. Excellent word processing, scientific writing, oral presentation and graphic documentation skills are required. Must be able to demonstrate a good attention to details and be goal-oriented, and quality conscientious. Strong computer skills in Word, Excel and Adobe Acrobat, with a working knowledge of electronic publishing/file management systems are an asset. Ability to use the Internet for research applications is required. Expected to demonstrate a good understanding of current US regulatory requirements, guidelines and regulations. Strong oral and written communication skills are required. Must be able to adapt to changing priorities and manage multiple tasks.