Senior Regulatory Affairs Specialist

Beacon Hill was founded to set a new standard in search, career placement and flexible staffing. This is a fully on-site role in St. Louis, MO. Local candidates are strongly preferred. The Senior Regulatory Affairs Specialist's responsibilities encompass the support of US FDA applications (NDAs, ANDAs, DMFs) and support of Regulatory activities including but not limited to: Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements Review, assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site Where appropriate, act as the CMC regulatory lead to cross-functional teams and other personnel on health authority requirements and preparation of information/technical data needed for support of post-approval changes Author/compile/submit post-approval change supplements Author/review updates to marketed product labeling Maintain regulatory knowledge of current guidelines and regulations Maintain current regulatory databases and produce various reports as needed Utilize and support electronic document management system Provides mentorship for entry-level and intermediate-level regulatory associates Essential Functions Authoring, organization, and preparation of electronic (eCTD) regulatory filings; also includes peer review of filings Understand, identify potential regulatory risks and recommend strategies based on current FDA/health authority requirements Manage multiple priorities Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession Process, interpret and provide recommendations for complex, unusual issues Critically review documentation for regulatory submissions and provide input for necessary revisions Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA,EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.). Requirements Bachelor Degree in scientific discipline required or equivalent work experience. 5 or more years of Regulatory experience or related field. RAC certification preferred. Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required. Project leadership or supervisory experience is preferred. Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally. Excellent written and oral communication skills. Use of software system to manage change controls. Strong background using Microsoft Office tools and Adobe Acrobat. Travel Time Required - up to 10% (May vary depending on region/site). Working Conditions: Standard office environment. Willingness to work in a team-based environment. Close attention to detail required. May be required to sit or stand for long periods of 8+ hours a day while performing duties. The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime, weekend work and holiday work is sometimes required. Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply. California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Company Profile: Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs. Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting Benefits Information: Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings. Beacon Hill. Employing the Future #J-18808-Ljbffr Beacon Hill Staffing Group, LLC