Bayside Solutions · 14 hours ago
Senior Manager, Regulatory Affairs
San Mateo County, CA
Contract
Onsite
Senior Level
$177K/yr - $198K/yr
5+ years expBayside Solutions is seeking a Senior Manager of Regulatory Affairs to provide regulatory advice and manage various Regulatory Affairs activities. The role involves obtaining and maintaining National Health Authority approvals and conducting regulatory research to support company decision-making.
Information TechnologyStaffing AgencyTelecommunicationsVirtual Reality
No H1B
Responsibilities
Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content
Correspond and collaborate with our colleagues and departments to achieve alignment
Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams
Perform regulatory research to inform business strategy. Assess and communicate risks
Assure that there are no significant interruptions to the business due to regulatory compliance issues
Collaborates across the organization at all levels, across functional groups, and with executive management
Develop regulatory strategies to inform associated budgets, tools, and specialized support. necessary for efficient operations
Establish collaborative and effective relationships with colleagues in Clinical, Clinical Operations, and Clinical Research Organizations to ensure cross-functional alignment and team effectiveness
Qualification
Required
Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience
Strong working knowledge of US FDA Pharmaceutical regulations and guidance
Proven track record of successful submissions within a regulatory environment
Exceptionally strong team player with excellent interpersonal and communication skills
Detail-oriented with strong organizational skills and high-quality standards
Preferred
Knowledge of EU EMA and Rest Of The World Pharmaceutical regulations and guidance preferred
Direct experience with IND/NDA filings
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
Company data provided by crunchbase