Manager, Regulatory Affairs
W2 Contract
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:
- Bachelor's Degree in a relevant field and 3+ 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.
- Exceptional team player with excellent interpersonal and communication skills.
- Detail-oriented with strong organizational skills and high-quality standards.
- Knowledge of EU EMA pharmaceutical regulations and guidance is preferred
- Direct experience with IND/NDA filings is preferred
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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