Bayside Solutions · 2 days ago
Sr. Manager / Associate Director, Regulatory Affairs US Lead
Santa Clara, CA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$195K/yr - $215K/yr
5+ years expBayside Solutions is seeking a dynamic and experienced Sr Manager / Associate Director of Regulatory Affairs. The role is responsible for ensuring the execution of the regional regulatory strategy in line with the global registration strategy of a project, providing regulatory support from proof of concept to post-approval for projects within the company's portfolio.
Information TechnologyStaffing AgencyTelecommunicationsVirtual Reality
Responsibilities
Primarily functions as a US-Regulatory Leader and is responsible for ensuring the execution of the regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL)
Provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company's portfolio
Depending on the candidate's skill set, may also be assigned as a Global Regulatory Leader (GRL) with full regulatory responsibility for one or more earlier stages
Leads and coordinates local project team members in developing a strategy for applicable documents/activities
Ensures the quality and content of submissions to Health Authorities
Depending on skill set and as deemed appropriate by the GRL, may lead regional Health Authority meetings and liaise with local Health Authority and company governance boards for assigned projects
Depending on the skill set and as deemed appropriate by the GRL, may be the document owner of briefing books to Health Authorities
Assist with the development of the global regulatory functional plan through the research, review, and interpretation of related product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling
Experience reviewing nonclinical, clinical, and CMC documentation (e.g., nonclinical study reports, clinical protocols/study reports, Investigator Brochures, CMC information/data) and contribute to content as needed
This position has a moderate-high level of autonomy with growth opportunities. Able to work in a Fast-paced environment, handling multiple demands is preferred
Qualification
Required
Advanced scientific degree (i.e., PhD, MD, PharmD) or master's degree with at least 5 years of drug development experience
Experience in Oncology is a great plus
Knowledge of Global regulatory procedures and practices, and awareness of evolving regulatory reform initiatives, is desirable
Demonstrated deep knowledge of the integrated drug development process and regulatory/business strategies
Strong written, spoken, and presentation communication
Demonstrated attention to detail
Travel expected (10%)
Preferred
Global Experience is a plus
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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