Senior Manager, Regulatory Affairs

Bayside Solutions; Palo Alto (CA); On-site; USD 170,000 - 190,000; Full time

Job summary

A leading solutions provider is looking for an experienced Sr. Manager of Regulatory Affairs in Palo Alto, California. This role is central to executing regional regulatory strategies and requires a strong background in drug development. The ideal candidate will hold an advanced scientific degree and have at least 5 years of experience, including familiarity with oncology. Responsibilities encompass providing regulatory support, ensuring quality submissions, and leading local project teams. Strong communication and attention to detail are crucial for success in this fast-paced environment.

Qualifications

• Minimum 5 years of drug development experience required.
• Oncology experience preferred.
• Strong verbal and written communication skills essential.

Responsibilities

• Lead the regional regulatory strategy in collaboration with the GRL.
• Provide regulatory support for projects across their lifecycle.
• Ensure quality and content of submissions to relevant authorities.
• Coordinate local project team members in strategy development.

Skills

US Regulatory Affairs Leadership

Global Regulatory Strategy Execution

Drug Development Lifecycle Support

Regulatory Submissions to Health Authorities

FDA and Global Health Authority Interactions

Attention to Detail

Cross-Functional Team Leadership

Strong Scientific and Technical Writing

Education

Advanced scientific degree (PhD, MD, PharmD) or master's degree

Job description

Salary Range

$170,000 - $190,000 per year

Job Summary

We are seeking a dynamic and experienced Sr. Manager 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 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. Leads and coordinates local project team members in developing a strategy for applicable documents/activities.

Duties and 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 contributing 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.

Requirements and Qualifications

• 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.
• Global Experience is a 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.
• Global Experience is a plus.
• Strong written, spoken, and presentation communication.
• Demonstrated attention to detail.
• Travel expected (10%).

Desired Skills and Experience

US Regulatory Affairs Leadership, Global Regulatory Strategy Execution, Drug Development Lifecycle Support (PoC to Post-Approval), Regulatory Submissions to Health Authorities, FDA and Global Health Authority Interactions, Global Regulatory Leader (GRL) Experience, Regional and Global Registration Strategy, Regulatory Strategy Development, Cross-Functional Team Leadership, Regulatory Document Strategy and Planning, Briefing Book Authorship and Ownership, Health Authority Meeting Leadership, Regulatory Governance and Agency Liaison, Regulatory Intelligence and Guidance Interpretation, Product Labeling Strategy, Nonclinical Documentation Review, Clinical Documentation Review, CMC Documentation Review, IND/NDA/BLA Support, Integrated Drug Development Knowledge, Oncology Drug Development Experience, Global Regulatory Procedures and Practices, Regulatory Compliance and Quality Oversight, Advisory Committee Research and Analysis, Strong Scientific and Technical Writing, Executive and Regulatory Presentations, Stakeholder Communication, Attention to Detail, Project Autonomy, Fast-Paced Multitasking Environment

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