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.
We are seeking a Director/Senior Director of Regulatory Affairs to lead global Regulatory Science and strategy for Neumora’s growing pipeline of novel preclinical and development compounds to treat neuropsychiatric and neurodegenerative diseases. In this role, we are looking for an experienced leader to drive thoughtful, innovative regulatory strategies to deliver on our mission to bring meaningful precision medicines to patients with brain diseases. You will work closely with cross-functional core team members, including data science, digital health technology, and the senior management team to develop and implement regulatory science related to nonclinical and clinical development, technical operations/CMC, medical affairs and early commercial planning, draft labeling and regulatory writing, and serve as Neumora’s primary liaison with the FDA.
- Serve as the global regulatory strategy lead, leveraging a network of external consultants and CROs, to develop, derisk and influence cutting edge strategic regulatory and development approaches in anticipation of the evolving regulatory and neuroscience landscape worldwide.
- Establish and maintain strong relationships with FDA and global health authorities. Act as a credible, influential, and respected corporate spokesperson for interactions and negotiations to support new INDs through approval of marketing applications, readiness for commercial activities.
- Ensure high-quality and timely regulatory submissions in compliance with all applicable regulatory requirements, in partnership with Neumora SMEs, external Regulatory PM/Medical Writing/Operations team members, and Neumora Regulatory Operations Lead.
- Develop strong and productive working relationships with key stakeholders throughout the company; Communicate effectively to ensure clear understanding of relevant regulatory science and compliance. Work closely with Chief Quality Officer and Chief Legal Officer to ensure compliance with worldwide regulatory requirements.
- BA/BS Degree required, preferably in health/life sciences or a related field.
- A minimum of 10 years in the bio/pharmaceutical industry and extensive experience in Regulatory Science and RA strategy, product and dossier lifecycle management, and interactions with Health Authorities; leadership of IND/CTA and NDA/MAA preparation preferred.
- Experience working in CNS therapeutic area and directly with the FDA Office of Neuroscience required (Division of Psychiatry and/or Division of Neurology I/II preferred)
- Thorough understanding of the regulatory environment in US and Europe and relevant drug development regulations and guidelines
- Ability to think creatively and develop creative solutions
- Excellent English verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to the internal and external stakeholders
- Able and willing to travel as needed
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: $201,335 - $266,259
To the fullest extent permitted by applicable law, this offer, and your employment with the Company, is conditioned upon your being fully vaccinated against COVID-19 (in accordance with current CDC guidelines), and your submission of documented proof thereof, as of your start date. The Company will comply with applicable law regarding the reasonable accommodation of individuals who are not fully vaccinated against COVID-19 because of a disability and/or sincerely held religious belief.
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.