Associate Director, Regulatory Affairs

Summary

Join MindMed, a clinical-stage biopharmaceutical company, as a Regulatory Affairs professional. You will contribute to the development and implementation of regulatory plans for current and future products, managing INDs, CTAs, NDAs, and MAAs. Responsibilities include acting as a key contributor on NDA submission initiatives, managing regulatory projects, developing regulatory strategies, participating in FDA meetings, and interacting with regulatory agencies. You will advise teams on broader development issues and monitor changes in the regulatory environment. This role requires a Bachelor's degree in a relevant scientific area, 8+ years of bio/pharmaceutical experience in drug development with regulatory affairs focus, and experience working with the FDA. MindMed offers competitive benefits including 100% paid health benefits, a 401(k) program, flexible time off, and generous parental leave.

Requirements

• Bachelors degree in a relevant scientific area, with advanced degree preferred
• 8+ years of bio/pharmaceutical experience in drug development with progressively increasing responsibilities in regulatory affairs
• Experience working with the FDA is required
• Deep regulatory experience is essential, including experience with developing broad plans for phase 3 pivotal trials and product registration and NDA regulatory experience in a relevant FDA review division
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company
• Attention to detail and quality are critical to success
• Able to command respect from peers and capable of highly independent work as well as being a team player and role model
• Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company
• Proven ability to manage multiple projects, identify and resolve issues
• Ability to travel up to 25%

Responsibilities

• Act as a key contributor on NDA submission-related initiatives, including document creation, label development and FDA Advisory Committee preparations
• Manage and lead regulatory projects as needed, providing strategic leadership and operational excellence
• Contribute to the development of appropriate regulatory strategies for projects at all stages of development, in collaboration with cross-functional members in areas such as medical, CMC, preclinical and project management
• Participate in FDA meetings for assigned projects, including the preparation of briefing materials, team preparation, meeting execution and follow-up communication of outcomes to MindMed stakeholders
• Interact with regulatory agencies with intelligence, diplomacy, and a tone that conveys collaboration and partnership. Develop and maintain strong relationships with regulatory agency staff
• Utilize development expertise to advise teams on broader development issues. Provide a big picture, unbiased perspective in all development discussions, seeking approvable development packages capable of commercial success
• Collaborate with third party regulatory and regulatory CMC consultants, and CRO’s to supplement expertise and operational capacity
• Serve as the subject matter expert on regulations, guidance documents, contemporary regulatory practices and relevant regulatory precedence to guide the overall development plans accordingly
• Proactively monitor changes in the regulatory environment and provide recommendations to R&D staff on how to address them appropriately, including modifications to development plans

Preferred Qualifications

• Psychiatry, Neurology, and Pain development experience, with a significant level of interaction with the relevant FDA review divisions highly preferred
• Global regulatory clinical trial experience and regulatory CMC experience are highly preferred
• Broad experience in a small company environment is a plus

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!