Director of Global Regulatory Strategy and Development

2 days ago


Boston, Massachusetts, United States Planet Pharma Full time
About the Role

We are seeking a highly skilled and experienced Director of Global Regulatory Strategy and Development to join our team at Planet Pharma. As a key member of our regulatory affairs team, you will play a critical role in developing and implementing global and US regulatory strategies for our unique and technologically complex products serving patients with rare diseases and unmet medical needs.

Key Responsibilities
  • Develop and direct innovative and effective regulatory strategies in support of specific projects, and across projects in the company portfolio.
  • Serve as global or US Strategy lead on assigned programs, acting as submission sub-team lead for US submissions and core member of Regulatory Subteam (RST) for assigned programs.
  • Provide advice on regulatory issues for both marketed and pipeline products, actively collaborating with management, Global Regulatory Lead, and cross-functional colleagues within the company.
  • Accountable for preparation and execution of regional aspects of the regulatory global strategy, including setting direction for junior staff to execute regional regulatory tasks according to strategy.
  • Represent the company as point contact for FDA and lead company delegation for regulatory authority meetings.
  • Lead US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, new marketing authorization applications, etc.
  • Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.
  • Provide support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
  • Ensure exemplary behavior, ethics, and transparency within the company and with regulatory agencies.
Requirements
  • Strong knowledge of US drug development and regulatory policy, excellent scientific and business judgment.
  • Experience providing US strategic regulatory advice for the global development of products through all stages of development, including pre-approval and marketed compounds.
  • Experience with leading major submissions and FDA meetings.
  • Ability to manage complex issues and coordinate multiple projects simultaneously.
  • Ability to build intra-team relationships and collaborate in a global team environment at all levels of the organization.
  • Strong interpersonal, and written/verbal communication skills.
  • Proven track record practicing sound judgment as it relates to risk assessment.
  • Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GMPs, GLPs, and GCPs; solid understanding of where to seek and how to interpret regulatory information.
  • Bachelor's Degree in a related discipline.
  • 5-7 years of experience.


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