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Senior Director, Regulatory Affairs & Lab Operations

Company: CSL Behring
Location: Boca Raton
Posted on: September 11, 2020

Job Description:

With operations in 35+ nations and - 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus. CSL Behring--is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma--, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!GENERAL SUMMARYThis position is responsible for leading and directing strategy for regulatory compliance for all CSL Plasma Inc. (CPI) operations, in the US and Europe.Authorized Official for contact with FDAServe as liaison/representative for company's submission to regulatory agenciesCollaborate with Regulatory Affairs efforts within the CSL Plasma Group and CSL Corporate to ensure regulatory requirements and the impact provide clear direction for the organizationLead and direct strategy for laboratory operations located I Knoxville, TN/US and Gottingen Laboratory in GermanyRESPONSIBILITIESRepresent CPI as an Authorized Official or responsible person in interactions with regulatory agencies worldwide. Directly interface with regulatory authorities as needed on issues.-- Maintain a positive relationship with all regulatory officcalls and respond to all inquiries in a timely fashion.-- Accompany and negotiate with European and other foreign health authorities during Center and laboratory audits, and conslult with FDA inspectors as needed.-- Serve as liaison/represnetative for company's submissions (BLA, PAS, CBE) to regulatory agencies.Lead the development of strategic and tactical objectives, plans and programs for Regulatory Affairs and CPI Laboratories that will position CPI as the industry leader in these areas.-- Advise senior management concerning regulatory requirements and the impact on project status and company compliance.-- Participate with new development teams to identify and evaluate new business opportunities.Responsible for the direction and leadership to the CPI Knoxville and Gottingen laboratories to ensure efficient and effective operations to deliver testing that meets the needs of CSL.Direct the definition and implementation of the regulatory strategy and policy for CPI, in order to meet company objectives and to ensure product manufacturing and development plans are scientifically sound and comply with federal, state and international regulatory authorities, and customer specifications in all CPI facilities.Provides consultation to other CPI departments for the development and implementation of business processes that impact regulatory compliance.--Senior Director (or delegate) review and approve of all Standard Operating Procedures (SOPs), including revisions to SOPs, procedures and training materials ensuring they comply with all governing agencies.Ensures that regulatory policies and procedures are written and implemented in accordance with all applicable international (GHA), federal (FDA, CLIA, OSHA), state, local and industry (ISO, QPP) regulations and requirements.--Directly responsible for the development and improvement of programs, policies and procedures that meet or exceed the requirements of all regulatory bodies and are designed and implemented to assure maximum efficiency and meet or exceed the expectations of all stakeholders.Maintain current knowledge of regulations, review laws and the Federal Register, and attend seminars and FDA hearings maintaining specific knowledge/licensure or certification a requirement of this position for Labs or organization in general.-- Maintain current knowledge of regulations.Maintain clean efficient work environment and ensure sufficient operating supplies and forms are available.-- Comply with all Health, Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures.-- Conduct routine internal procedures and documentation audits, as applicable.-- Promote safety in all actions.--Manage staff, including selection, training, development, coaching and termination.-- Appraise employee performance and provide feedback and counseling to staff, when necessary.-- Develop succession plans and oversee career development of immediate staff.-- Develop and manage to annual budgets designed to meet or exceed objectives by continuous review of performance against KPIs.--JOB SPECIFICATIONSEducationBachelor's degree requiredDoctoral degree in Biological Sciences or related health sciences preferredExperience15+ years of progressively responsible experience in an FDA regulated industry, or with the FDA, including some lab and GMP experienceDirect supervisory experience (both professional staff and line personnel)Project management experienceAdditional Comments--Strong technical background, familiarity with cGMP, FDA, CLIA, OSHA and EU regulations related to Biologics and pharmaceutical manufacturingWorking ConditionsUnderstands opposing points of view on highly complex issues and negotiates different viewpointsAbility to make decisions which have significant impact on the immediate work unit and monitor impact outside immediate work unitAbility to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentationsOccasionally exposed to hazardous chemicals, extreme temperatures and to blood borne pathogensOvernight travel required up to 30% of the timeFast paced environment with frequent interruptions#CBWorker Type:EmployeeWorker Sub Type:ExecutiveFull time

Keywords: CSL Behring, Boca Raton , Senior Director, Regulatory Affairs & Lab Operations, Executive , Boca Raton, Florida

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