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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Director Global Regulatory Lead Early Clinical Development


Reference:SCA014111 Location: Cork
Qualification:DegreeExperience:10+ Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Clinical Research, Regulatory Affairs Consultant, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Specialist

Senior Director Global Regulatory Lead Early Clinical Development
Our client, a global pharma company, are currently recruiting for a Senior Director Global Regulatory Lead Early Clinical Development to joint their team on a permanent basis. As Senior Director Global Regulatory Lead Early Clinical Development you will be the regulatory regional lead for assigned molecules in development. You will be responsible for driving the regulatory strategy for development in the US and Canada from discovery through the start of registration studies. You will partner with other global regulatory scientists to develop and execute global regulatory strategy outside the US and Canada. As Senior Director Global Regulatory Lead Early Clinical Development you will be expected to take reasoned risks and leverage innovative regulatory strategies that can accelerate the development of assigned molecules. This is a very exciting to join a company with a very strong product portfolio and pipeline. This role offers hybrid working.

Responsibilities

  • Provide leadership by developing and executing innovative regulatory strategies
  • Work independently in a role that demonstrates organizational influence within and across functions. For example, influences cross-functional teams on clinical development strategy and trial design
  • Acts as direct liaison with FDA and Health Canada
  • Execute high quality communications with regulators and internal customers to articulate and ensure understanding of the regulatory strategy and complex issues
  • Actively seek to deepen regulatory knowledge through constant learning
  • Readily shares information and regulatory knowledge with others
  • Engage in, influence, and shape external environment initiatives related to portfolio assets
Requirements:
  • Bachelor's degree in scientific area and at least 10 years of industry-related experience in regulatory affairs and/or drug development OR Advanced scientific degree (e.g., PhD, PharmD) with at least 8 years of industry-related experience in regulatory affairs and/or drug development
  • Knowledge of FDA and Health Canada procedures and practices and awareness of evolving regulatory initiatives desirable
  • Demonstrated deep knowledge of the drug development process
  • Demonstrated ability to assess and manage risk in a highly regulated environment
  • Demonstrated strong written, spoken and presentation communication skills
  • Demonstrated ability to negotiate and influence
  • Demonstrated attention to detail
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal s
For more information please contact Sinéad Cullen on +353879500821 or [email protected]