Regulatory Affairs Senior Regional Manager

Salary depends on experience
Posted on 02/18/18
King Of Prussia, PA
8 - 10 years experience
Medical Devices & Diagnostics
Salary depends on experience
Posted on 02/18/18

Job Description

Serve as Regulatory Regional Senior Manager NA, Development Products for allocated product portfolio

  • Develop regional regulatory strategies considering regional requirements, scheduling and priority setting
  • Ensure all regulatory activities are in alignment with the strategic direction of the GRAST-DP
  • Contribute to a GRA Strategy Document for complex projects and provide review of regional regulatory strategies
  • Participate in GRASTs, and as applicable provide regulatory guidance on regional, regulatory procedures and HA requirements
  • Contributes to the compilation of high quality documentation for submissions in the region ensuring content and format requirements are met
  • Lead the preparation and contribution of briefing packages for assigned projects
  • Communicate submission dates and approval dates to stakeholders, as applicable
  • Ensures timing of submissions are met with agreed upon timelines
  • Serve as Health Authority contact for all assigned projects
  • Lead HA authority meetings from a regulatory perspective for assigned projects
  • Develop and maintain effective working relationships with regional regulatory agencies demonstrated by high quality communication and effective use of negotiation skills to achieve positive outcomes for CSL Behring
  • Support the GRL/product specialist for the strategy, planning and preparation of response for complex scientific questions requiring product expertise and contacting internal stakeholders
  • Independently provide responses to simple, routine requests not requiring product expertise or input from otherinternal stakeholders
  • Monitor current and proposed regulatory requirements to provide applicable regulatory advice to project teams to ensure HA compliance while meeting business objectives
  • Mentor Regional Managers and /or Regulatory Specialists

Education

A degree in a scientific background, preferably with a post graduate qualification.

Certification/Degree in Drug Regulatory Affairs advantageous.

Experience

  • Seven to 10 years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience.
  • Extensive experience with drug development and strong working experience with CBER requirements
  • Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (relevant) regional Regulatory Authorities.
  • Understanding of the principles of GMP, GCP and GLP.
  • Strategic and tactical thinking ability, complemented by a “hands on” operational approach and business planning orientation.
  • Ability to identify the ‘big picture’ and opportunities/major issues and link day to day tasks with long term goals.
  • Demonstrated ability to deal with rapid change.
  • Demonstrated sound judgment and flexible approach to managing situations.
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