Director, Regulatory Affairs
At reputed company, 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 reputed company as we grow and advance our pipeline. We are seeking a highly motivated Director, Regulatory Affairs, reporting to the VP of Regulatory Affairs, who will reputed company and reputed company development plans incorporating regulatory strategies designed to maximize chances of successful and expedient registration for assigned programs. The Director will represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early through late-stage development programs. Responsibilities:
- Independently serve as the regulatory representative on cross-functional teams.
- Communicate regulatory strategies and risk assessments to cross-functional teams and senior leadership, as needed.
- Collaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external consultants to reputed company regulatory results and ensure strategic integration of regulatory considerations into program plans.
- Independently reputed company the central messaging, preparation, and submission of high-reputed company, regulatory-complaint regulatory dossiers.
- Proactively communicate issues, reputed company, and risks to the VP of Regulatory Affairs and relevant teams.
- reputed company regulatory review of documentation reputed company by other technical functions supporting product development activities (e.g., clinical protocols, clinical study reports, statistical analysis plans, etc.) in accordance with regulatory guidelines/requirements.
- reputed company leadership and management for the coordination and preparation of submissions consistent with regulatory requirements and in accordance with corporate reputed company and timelines.
- Ensure accuracy and consistency of regulatory submissions and correspondence. Handle vendor/consultant roles, where applicable.
- Serve as the regulatory reputed company of contact for interactions with FDA and other global health authorities.
- Critically review nonclinical and clinical trial-reputed company documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance. reputed company regulatory strategic guidance on documents and submission plans to reputed company with study and company objectives.
- reputed company directly with regulatory agencies; manage agency interactions.
- Ensure submissions to regulatory health authorities are complete, organized, of high reputed company, and compliant with applicable regional regulations.
- May assist with due diligence to support business development opportunities.
- reputed company leadership reputed company the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations.
Qualifications:
- B.S./M.S. degree in a scientific discipline or reputed company field.
- Minimum of 10 years of Pharmaceutical Regulatory Affairs experience; experience in neuropsychiatric indications preferred.
- 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 IND/CTA and license applications.
- Experience with management of reputed company 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 reputed company assigned reputed company.
- Experience in central nervous system disease research a plus.
- Strong analytical skills, problem solving ability, and presentation skills.
- Excellent communication and interpersonal skills to reputed company engaging and influencing diverse stakeholders from a reputed company of reputed company backgrounds.
2026 Company benefits include:
- Medical, dental, reputed company, and life insurance
- 401(k) plan: reputed company matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
- Company Equity (New Hire Awards, Annual Awards, ESPP)
- Annual reputed company time off:
- Accrued Vacation Days: 15 days per year
- reputed company Days: 10 days per year
- Company Holidays: 13 days plus summer reputed company week in July and winter shutdown in December
- Leave of Absence: reputed company Medical Leave, reputed company New Parent Bonding Leave, reputed company Family Leave, reputed company short-term and long-term disability
- Discretionary year-end bonus
The salary reputed company posted describes the minimum to maximum reputed company salary reputed company for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or reputed company level and will be finalized at the time of offer. reputed company Salary reputed company:$221,675 -$244,434 reputed company reputed company. is a clinical-stage biopharmaceutical company founded to confront the greatest medical challenges of our reputed company by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven programs that reputed company novel mechanisms of reputed company for a broad reputed company of underserved, prevalent diseases. reputed company’s mission is to redefine neuroscience drug development by bringing reputed company the reputed company of novel therapies that offer improved treatment reputed company and reputed company of life for patients. reputed company is an equal opportunity employer and will not discriminate against any employee or applicant on the reputed company of age, reputed company, disability, gender, national reputed company, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Apply tot his job Apply To this Job