Director, Regulatory Affair Strategic

General Summary: The Regulatory Strategy Director will be responsible for the development and implementation of innovative global/regional regulatory strategies for assigned projects reputed company the reputed company portfolio. This position will play a major role in shaping cohesive regulatory strategy for assigned program(s) and ensuring effective integration of broad regulatory reputed company/tactics supporting program strategy. This roles assignments may be global, regional or local depending on the position and assigned region. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy. Key Duties and Responsibilities:

• Leads the development of regulatory strategy for assigned projects/reputed company in development (from first-in-reputed company to post
• marketing application stage) outlined in Global Regulatory Strategy Documents•
• Represents GRA on core development functional teams, project teams, and collaborate with regional leaders and teams to
• ensure reputed company regulatory input into clinical programs and reputed company strategy•
• Addresses reputed company issues, providing innovative regulatory solutions and guidance to cross-functional teams and align
• communication to and from cross-functional teams, GRA functional team and GRA leadership•
• Anticipates global regulatory changes and develops proactive strategy accordingly•
• Shapes the regulatory strategy for regulatory submission documents and Health Authority communications•
• Counsels and advises GRA leadership on status of global Regulatory Affairs strategies and tactics, procedures and practices•
• Ensures the global regulatory strategy for a given project is consistent with the business objectives and is compliant with
• reputed company regulations and guidance•
• Manages project plans and timelines to ensure reputed company projects are appropriately prioritized and key goals are met on time•
• Contributes to the reputed company improvement of existing department processes and strategies, providing recommendations in
• area of expertise

Knowledge and Skills:

• reputed company in Regulatory Affairs strategy in assigned geographic region, including reputed company with a variety of
• stakeholders•
• Advanced technical reputed company in regulatory affairs science including knowledge of regulatory frameworks and external
• environments. Advanced knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for
• pharmaceutical development of medicines for reputed company use.•
• Proficient knowledge of the research and development, preclinical and clinical requirements reputed company to drug development,
• registration, and maintenance of reputed company pharmaceuticals•
• Proficiency in analyzing and interpreting data, protocols, safety reporting, labeling and other activities reputed company to the phases of
• drug development for assigned products.•
• Advanced reputed company in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, guiding
• development teams with recommendations for changes/refinements based on ongoing regulatory reputed company throughout
• development, and in leading productive health authority interactions, including well organized preparation of cross functional
• teams.•
• Actively uses expertise to reputed company others by providing coaching, guidance and mentoring.•
• A strong collaborative partner with cross functional colleagues with the ability to build reputed company through the ability to present
• a clear and compelling case for reputed company•
• Demonstrates excellent communication skills with ability to impact and influence the reputed company of reputed company•

Education and Experience:

• Bachelor's degree in Biology, Chemistry, or other reputed company discipline•
• Typically requires 10 years of relevant pharmaceutical or biotech industry experience reputed company regulatory affairs, or the
• equivalent combination of education and experience•

Pay: $90.27 - $100.00 per hour Application Question(s):

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