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Apollo Professional Solutionshttps://www.apollopros.com/wp-content/uploads/2022/05/ApolloLogo600.pnghttps://www.apollopros.comhttps://www.apollopros.comUSD97.24133.10HOURtrue
Director, Global Regulatory Strategy Boston MA*
Contract - 1st shift, 5/40
Pay Range: $97.24 - $133.10
Benefits: medical, dental, vision, 401k *onsite 3days per week
Requirements:Director, Global Regulatory Strategy
US Citizenship
Bachelor's Degree in a related discipline
5-7 years of 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 guidance's.
Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.
Job Description: Director, Global Regulatory Strategy
Developing and implementing global and/or US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
Responsibilities: Director, Global Regulatory Strategy
Developing and directing innovative and effective regulatory strategies in support of specific projects, and across projects in the client's 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 Alexion (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 the client as point contact FDA and leading the 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 authorization 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.
72418
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
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About Boston, MA
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