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Senior Director, Regulatory Affairs & Lab Operations

Location: Boca Raton
Posted on: September 12, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

Represent company 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 company Laboratories that will position company 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 company and Gottingen laboratories to ensure efficient and effective operations to deliver testing that meets the needs of company.

Direct the definition and implementation of the regulatory strategy and policy for company , 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 company facilities.

Provides consultation to other company 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.

Doctoral degree in Biological Sciences or related health sciences preferred

15+ years of progressively responsible experience in an FDA regulated industry, or with the FDA, including some lab and GMP experience

Direct supervisory experience (both professional staff and line personnel)

Keywords: CSL LIMITED, Boca Raton , Senior Director, Regulatory Affairs & Lab Operations, Other , Boca Raton, Florida

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