Senior Manager, Regulatory Affairs

Salary Range: $176,800 - $197,600 per year

Location: Redwood City, CA - Onsite Role

Job Summary:

The Senior Manager of Regulatory Affairs 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, 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.

Requirements and Qualifications:

• 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 Qualifications:

• Knowledge of EU EMA and Rest Of The World Pharmaceutical regulations and guidance preferred.
• Direct experience with IND/NDA filings.

Desired Skills and Experience

Regulatory Affairs leadership, regulatory strategy development, regulatory document planning and submission, global regulatory submissions, National Health Authority interactions, FDA pharmaceutical regulations, EMA and international pharmaceutical regulations, IND and NDA filings, clinical regulatory submissions, preclinical regulatory submissions, CMC regulatory content, regulatory intelligence and research, regulatory risk assessment and communication, regulatory compliance management, cross-functional team leadership, study team and submission team participation, collaboration with Clinical and Clinical Operations, CRO collaboration, executive-level stakeholder collaboration, regulatory project management, business strategy support, budget and resource planning, regulatory correspondence, organizational and documentation excellence, strong interpersonal and communication skills, quality and detail-oriented regulatory oversight

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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