Senior Manager

This role’s primary responsibility is to partner with Regulatory Affairs leaders (in each therapy area) to obtain and maintain regulatory filings and registrations for domestic and international regions. The Sr. Manager will coordinate activities with internal team members and external parties (e.g., regulatory bodies; vendors; consultants) to maintain up-to-date information on regulatory requirements and product submissions. This position will be onsite in Menlo Park, CA, typically 3 days per week.

Responsibilities:

• Manages most aspects of company regulatory interface with domestic and international health authorities
• Manages the development and deployment of the regulatory program that ensures aggressive product approval
• Manages and may generate regulatory submission documents for new products or changes to existing health authorities’ filings, including domestic and international submissions and registration
• Manages the submissions of clinical study submissions
• Determines governmental regulations affecting company processes and assures the processes are complete and accurate to ensure company compliance
• Partners with various teams throughout organization (Clinical Operations, R&D, Quality, etc.) on projects
• Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations
• Provides guidance with localization and labeling requirements
• Manages regulatory reporting 

Preferred Skills, Qualifications and Technical Proficiencies:

• 5 + years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries
• Strong analytical and problem-solving skills
• Strong written and verbal communication skills, including the ability to interact effectively and to influence
• Strong attention to detail
• Customer focused and adaptable, with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations
• High functioning as both a team player and individual contributor

Preferred Education and Experience:

• Bachelor’s or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline

The pay range that the Company reasonably expects to pay for this headquarters-based position is $180,000 - $210,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.