Senior Manager, 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 Manager, Regulatory Affairs, reporting to the VP of Regulatory Affairs, who will support regulatory activities from early development through NDA for assigned programs, while ensuring compliance with all global regulatory standards and guidelines.
- Develop and/or execute regulatory strategies and assigned projects to support global clinical development, approval, and commercialization.
- In conjunction with the Regulatory Lead, provide regulatory support and contribute to the development and implementation of regulatory strategies to support the approval and commercialization of assigned products in compliance with applicable Health Authority requirements, including the identification of gaps or risks and opportunities to expedite development through innovative pathways.
- Collaborate cross-functionally with internal teams and subject matter experts to provide regulatory guidance and support throughout the product lifecycle and to prepare regulatory submissions (e.g., meeting requests, briefing documents, IND/CTA filings, marketing applications, designation requests, etc.).
- Oversee content development, organization, and coordination of cross functional regulatory submissions (e.g., INDs, CTAs, NDAs).
- Learn and maintain detailed knowledge of the evolving global regulatory landscape relevant for assigned programs including expedited programs. Assess the impact of new regulations/guidance on internal programs and communicate relevant changes to internal stakeholders.
- Contribute to regulatory department initiatives to optimize procedures and working practices.
- BS or MS degree in a scientific discipline or related field.
- Minimum of 5 years of experience in the pharmaceutical or biotechnology industry including at least 3 years of experience within the Regulatory Affairs function.
- Regulatory experience with INDs and/or CTAs. Life cycle experience a plus.
- Experience in preparing documents for regulatory submissions including IND/CTA, NDA/MAA.
- Knowledge and understanding of US and international regulations and ICH guidelines related to pharmaceutical development.
- Experience supporting the development and implementation of regulatory strategies.
- Experience assisting with the development of briefing documents and interfacing with regulatory agencies desirable.
- Strong interpersonal skills and the ability to collaborate effectively with various technical area experts.
- Excellent communication and interpersonal skills to enable engaging and influencing diverse stake holders 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: $148,785- $162,750
Neumora Therapeutics is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of multiple clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases.
Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from 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.