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
A degree in a scientific background, preferably with a post graduate qualification.
Certification/Degree in Drug Regulatory Affairs advantageous.
- 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.