Director / Sr Director of Regulatory Affairs Lead
Bayside Solutions, Santa Clara, California, us, 95053
Overview
Director / Sr Director of Regulatory Affairs Lead
Salary Range:
$240,000 - $270,000 per year
Job Summary: We are seeking a dynamic and experienced Director/ Sr Director of Regulatory Affairs to be responsible for developing and implementing global strategies to secure and maintain market approval for product(s) globally (US, EMA, Japan, Australia, Canada). This role leads the Global Regulatory Team. Serves as the primary regulatory interface with the product development team and supporting functions. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates leadership behaviors to build a cohesive team environment. Must have a solid understanding of drug development, regulatory requirements, and develop and implement accelerated submission strategies.
Responsibilities
Leads the GRT to the development of creative global strategies in line with applicable laws and regulations to achieve business objectives for the development and marketing of products.
Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory agency requests.
Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
Prepares and maintains regulatory risk assessment and mitigation strategy and communicates the plan to relevant stakeholders.
Acts independently and collaborates with the GRA Head. May participate in or lead regulatory and Company initiatives.
Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives as agreed with the senior management.
Requirements and Qualifications
Advanced scientific degree (i.e., PhD, MD, PharmD) or master's degree, with at least 10 years of drug development experience. GRL experience in Oncology is a great plus.
Required Experience: 10+ years' experience in pharmaceutical regulatory activities, with experience as a lead regulatory strategist in two or more major regions in addition to the US, such as the EU.
Strong global drug development foundation with business acumen.
Travel expected (10%)
Desired Skills and Experience Global regulatory affairs strategy, Global Regulatory Team leadership, Regulatory submissions and approvals (US FDA, EMA, Japan PMDA, Australia TGA, Health Canada), Global drug development, Regulatory policy and strategy development, Accelerated submission strategies, Market authorization lifecycle management, Regulatory risk assessment and mitigation, Cross-functional leadership and stakeholder management, Regulatory dossier development and review, Agency interactions and negotiations, Responses to regulatory agency requests, Compliance with global regulatory requirements, Regulatory intelligence and legislative analysis, Influence on regulatory guidance and policy, Oncology regulatory strategy, Lead regulatory strategist experience, Business acumen in drug development, Strategic decision-making, Program and operational planning, Executive-level communication, Global product development support
Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.
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Salary Range:
$240,000 - $270,000 per year
Job Summary: We are seeking a dynamic and experienced Director/ Sr Director of Regulatory Affairs to be responsible for developing and implementing global strategies to secure and maintain market approval for product(s) globally (US, EMA, Japan, Australia, Canada). This role leads the Global Regulatory Team. Serves as the primary regulatory interface with the product development team and supporting functions. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates leadership behaviors to build a cohesive team environment. Must have a solid understanding of drug development, regulatory requirements, and develop and implement accelerated submission strategies.
Responsibilities
Leads the GRT to the development of creative global strategies in line with applicable laws and regulations to achieve business objectives for the development and marketing of products.
Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory agency requests.
Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
Prepares and maintains regulatory risk assessment and mitigation strategy and communicates the plan to relevant stakeholders.
Acts independently and collaborates with the GRA Head. May participate in or lead regulatory and Company initiatives.
Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives as agreed with the senior management.
Requirements and Qualifications
Advanced scientific degree (i.e., PhD, MD, PharmD) or master's degree, with at least 10 years of drug development experience. GRL experience in Oncology is a great plus.
Required Experience: 10+ years' experience in pharmaceutical regulatory activities, with experience as a lead regulatory strategist in two or more major regions in addition to the US, such as the EU.
Strong global drug development foundation with business acumen.
Travel expected (10%)
Desired Skills and Experience Global regulatory affairs strategy, Global Regulatory Team leadership, Regulatory submissions and approvals (US FDA, EMA, Japan PMDA, Australia TGA, Health Canada), Global drug development, Regulatory policy and strategy development, Accelerated submission strategies, Market authorization lifecycle management, Regulatory risk assessment and mitigation, Cross-functional leadership and stakeholder management, Regulatory dossier development and review, Agency interactions and negotiations, Responses to regulatory agency requests, Compliance with global regulatory requirements, Regulatory intelligence and legislative analysis, Influence on regulatory guidance and policy, Oncology regulatory strategy, Lead regulatory strategist experience, Business acumen in drug development, Strategic decision-making, Program and operational planning, Executive-level communication, Global product development support
Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.
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