Senior Director, Regulatory Affairs
At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline.
Neumora was listed as #1 on BioSpace’s NextGen Bio “Class of 2023,” top life sciences startups to watch!
We are seeking a highly motivated Senior Director, Regulatory Affairs, reporting to the VP of Regulatory Affairs, who will lead and oversee development plans incorporating regulatory strategies designed to maximize chances of successful and expedient registration for assigned programs. The Senior Director will represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early through late-stage development programs.
- Manage clinical development program planning to anticipate changes in regulatory environment and approval requirements.
- Monitor current and proposed regulatory issues. Provide risk assessments and recommendations for various regulatory scenarios.
- Work with external vendors to plan, prepare, submit, and maintain CTAs in Europe, LATAM, Asia-Pacific, and other regions.
- Critically review nonclinical, chemistry, manufacturing and controls, and clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance. Provides regulatory strategic guidance on documents and submission plans to align with study and company objectives.
- Interact directly with regulatory agencies; manages agency interactions.
- Ensure submissions to regulatory health authorities are complete, organized, of high quality, and compliant with applicable regional regulations.
- May assist with due diligence to support business development opportunities.
- Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimization and efficiency commensurate with departmental growth.
- Provide leadership within the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations.
- B.S./M.S. degree in a scientific discipline or related field.
- Minimum of 10 years of Pharmaceutical Regulatory Affairs experience.
- Thorough knowledge of the drug development process, drug laws, and global regulations and requirements is required.
- Experience supporting development stage programs (Phase 1-3).
- Experience with submission of license applications and management of commercial product(s) highly desirable.
- Ability to work in a hybrid environment and with distributed teams; startup/small company experience preferred.
- Self-starter who can independently lead assigned projects.
- Experience in central nervous system disease research a plus.
- Strong analytical skills, problem solving ability, and presentation skills.
- Excellent communication and interpersonal skills to enable engaging and influencing diverse stakeholders from a variety of professional backgrounds.
Company benefits include:
- Medical, dental, vision, and life insurance
- 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
- New hire stock options
- Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down
- Leave of Absence: Paid family leave, paid short- and long-term disability
- Discretionary year-end bonus
The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $250,000- $265,000
Neumora Therapeutics, Inc. is a clinical-stage biotechnology company pioneering precision medicines for brain diseases through the integration of data science and neuroscience. Neumora is redefining neuroscience research and development with a data-driven precision neuroscience platform to cut through brain disease heterogeneity to match the right patient populations to targeted therapeutics. Neumora is relentless in its commitment to discovering, developing and commercializing targeted therapies for people living with brain diseases.
Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.