Senior Manager, Regulatory Affairs

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

Job summary

Bayside Solutions seeks a Sr. Manager of Regulatory Affairs to oversee the regional regulatory strategy in line with the global plan.

You will collaborate with the Global Regulatory Leader to drive PoC through post-approval activities, leading local teams and shaping regulatory documents for Health Authorities. The role requires strong communication, deep regulatory knowledge, and the ability to navigate a fast-paced environment with 10% travel.

Qualifications

• Advanced scientific degree (PhD/MD/PharmD) or master’s with at least 5 years of drug development experience.
• Experience in Oncology is a great plus.
• Global regulatory procedures and practices knowledge desirable.
• Strong written, spoken, and presentation communication.
• Travel expected (10%).

Responsibilities

• Lead US regulatory strategy aligned with the global registration plan.
• Provide regulatory support from PoC through post-approval for projects.
• May serve as Global Regulatory Leader (GRL) with full regulatory responsibility.
• Lead local project teams in developing strategies for documents/activities.
• Ensure quality and content of submissions to Health Authorities.

Skills

Regulatory leadership

Global regulatory strategy

Drug development

FDA interactions

Health Authority liaison

Regulatory submissions

Documentation strategy

Briefing book ownership

Cross-functional leadership

Attention to detail

Travel

Education

PhD/MD/PharmD or Master’s with 5+ years drug development

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