Public affairs Jobs in Riverside ca

Regulatory Affairs Manager

W2 Contract

Salary Range : $145,600 - $166,400 per year

Location : Redwood City, CA - Hybrid Role

Job Summary :

As a Regulatory Affairs manager, you will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making.

Duties and Responsibilities :

• Manage planning, preparing, coordinating, and submitting regulatory documents to global National Health Authorities. Submissions may include Clinical, Preclinical, or CMC content.
• Correspond and collaborate with 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 business due to regulatory compliance issues.
• Collaborate across the organization at all levels, functional groups, and with executive management.
• Develop regulatory strategies to inform associated budgets, tools, and specialized support for efficient operations.

Requirements and Qualifications :

Desired Skills and Experience

Regulatory Affairs, FDA, regulatory submissions, drug development, EU EMA, IND / NDA

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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