Director, GRA GPS Early Development Lead

United States of AmericaR-0550642012 CSL Behring L.L.C.

Job Description

-Accountable for global regulatory development strategies for all assigned projects, typically in pre-clinical or Phase I of development. 

- In collaboration with GRA regional partners, work to envelope regional regulatory input into global regulatory strategies for development programs and oversee critical deliverables in alignment with commercial expectations. Ensure these strategies are accurate, balanced and consistent with project objective, including:

  • Advising on the need to seek external expertise
  • Ensure global regulatory strategies are updated for stage gate evaluations
  • Ensure global regulatory strategies are consolidated within GRA reflecting “one voice”

-Responsible to provide the strategic regulatory interface with Senior Scientific, Clinical R&D, Global Clinical Safety & Pharmacovigilance (GCSP), Project Management and Commercial Management. This includes fostering and maintaining a good relationship with internal stakeholders.

-Propose and develop/refine, implement and maintain global regulatory processes for the continued success of the function.

- Presents and informs senior management on regulatory strategies and key issues.

Experience and Requirements:

A bachelor degree in a scientific or related field, such as pharmacy, biology, chemistry, pharmacology,  or other related life science is required.  An advanced degree is preferred (MS, PhD or MD, DVM).

  • Minimum of 15 years’ experience in the biotech or pharmaceutical industry, with at least 9 years in Regulatory Affairs
  • Experience in working within a matrix environment and can demonstrate setting clear direction, holding people accountable and fostering a collaborative team environment.
  • Candidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (EU, US, Japan)
  • Experience working in Regulatory Affairs in a global environment across two or more geographic areas (preferentially US and EU).
  • Relevant experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies.
  • Demonstrated experience in working with multiple stakeholders.