We're looking for a candidate to fill this position in an
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
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
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
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
15+ years of progressively responsible experience in an FDA
regulated industry, or with the FDA, including some lab and GMP
Direct supervisory experience (both professional staff and line