Global Strategic Sourcing & Procurement Associate Director, Clinical Outsourcing
Boston, MA, United States
28630- Global Regulatory Strategy Director, Boston, MA 5 Months
Sigma Systems is seeking a Global Regulatory Strategy Director
Director, Global Regulatory Strategy
Responsibilities:
Developing and directing innovative and effective regulatory strategies in support of specific projects, and across projects in the Client portfolio.
Serving as global or US Strategy lead on assigned programs. Acting as submission sub-team lead for US submissions and is core member of Regulatory Subteam (RST) for assigned programs.
Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Client (i.e., commercial, research, clinical development medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
Accountable for preparation and execution of regional aspects of the regulatory global strategy. Can include setting direction for junior staff to execute regional regulatory tasks according to strategy.
Representing Client as point contact FDA and leading Client delegation for regulatory authority meetings.
Leading US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, new marketing authorisation applications, etc.
Monitoring the development of new regulatory requirements or guidance documents and advising product teams of the impact on the business or development programs. Providing support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
Ensuring exemplary behavior, ethics and transparency within the company and with regulatory agencies.
Requirements:
Bachelor's Degree in a related discipline
5-7 years experience
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
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