Bayside Solutions · 5 days ago
Director / Sr Director of Regulatory Affairs Lead
Palo Alto, CA
Full-time
Hybrid
Director/Executive
$240K/yr - $270K/yr
10+ years expBayside Solutions is 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. This role leads the Global Regulatory Team and serves as the primary regulatory interface with the product development team, ensuring compliance with global regulatory requirements.
Information TechnologyStaffing AgencyTelecommunicationsVirtual Reality
Responsibilities
Leads the GRT to the development of creative global strategies in line with applicable laws. 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
Qualification
Required
Advanced scientific degree (i.e., PhD, MD, PharmD) or master's degree
At least 10 years of drug development experience
10+ years' experience in pharmaceutical regulatory activities
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%)
Preferred
GRL experience in Oncology is a great plus
Global regulatory affairs strategy
Global Regulatory Team leadership
Regulatory submissions and approvals (US FDA, EMA, Japan PMDA, Australia TGA, Health Canada)
Oncology regulatory strategy
Company
Bayside Solutions
Bayside Solutions is a staffing and recruiting company offering IT, telecom, and scientific staffing services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
B
Bob Klotz
Founder
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