Senior Manager Regulatory Affairs (Contract)

Key Responsibilities

• Serve as the Regulatory Affairs representative for Phase 1 to Phase 3 trials, ensuring regulatory activities are evaluated, prioritized and executed to meet global regulatory requirements.
• Serve as the Regulatory Affairs representative on assigned study teams and assure the progress of studies by addressing regulatory related queries in support of regulatory approvals.
• Lead preparation, review and submission of INDs/CTAs, amendments, review and approval of investigator document packages and manage other regulatory activities of the assigned studies as needed.
• Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for Phase 1 to 3 trials.
• Interact with Contract Research Organization (CRO) Regulatory Affairs counterpart.
• Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.

Qualifications

• Education: Bachelor’s or advanced degree in scientific discipline, with a minimum of 5 years of experience working in drug development in the biopharmaceutical industry and at least 3 years of experience in Regulatory Affairs; immunology or rare disease/orphan drug development experience desirable.
• Knowledge/Skills/Abilities: Direct experience with pharmaceutical global regulatory submissions and contributing to major regulatory filing(s) such as IND/CTA, working knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices, demonstrated experience in successfully leading assigned activities within cross-functional teams, excellent verbal and written communication skills, collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions, ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others, prior management experience a plus.

Responsibilities

The responsibilities may require a work schedule that may include working outside of “normal” work hours, to meet business demands.

Pay

The salary range for this position is $165,000 USD to $195,000 USD annually paid hourly per contract. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

Benefits

• Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
• Other Benefits Include:
• Health insurance premiums paid at 90% for employee, 80% for dependents
• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with yummy snacks and drinks!