Associate Director, Regulatory Affairs

Mind Medicine; United States; Remote; USD 144,000 - 176,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a Regulatory Affairs expert to drive the development and approval of groundbreaking treatments for brain health disorders. This pivotal role involves leading NDA submissions, managing regulatory projects, and fostering relationships with regulatory agencies. The ideal candidate will have extensive experience in drug development, particularly in psychiatry and neurology, and possess strong communication skills to navigate complex regulatory landscapes. Join a dynamic team dedicated to improving patient outcomes and making a significant impact in the field of mental health.

Benefits

100% Paid Health Benefits

401(k) with Company Match

Flexible Time Off

Generous Parental Leave

Fun Fringe Perks

Qualifications

• 8+ years of experience in bio/pharmaceutical drug development.
• Deep regulatory experience with NDA submissions and phase 3 trials.

Responsibilities

• Lead NDA submission initiatives and regulatory project management.
• Collaborate with internal teams and regulatory agencies.

Skills

Regulatory Affairs

Drug Development

FDA Interaction

Project Management

Communication Skills

Education

Bachelor's Degree in a Relevant Scientific Area

Advanced Degree (Preferred)

Job description

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.

Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.

Reporting to the Executive Director, Regulatory Affairs, this critical position will be responsible for assisting with the development and implementation of strategic and operational regulatory plans for the current and future indications for MindMed’s development assets and any future marketed products. The incumbent will play a critical role in maintaining MindMed’s investigational applications (IND, CTA), as well as the filing and approval of MindMed’s marketing applications (NDA, MAA). The individual will also play an important role in maintaining effective communication and constructive working relationships with both internal and external collaborators and regulatory authorities. The individual will also have the ability to contribute to building the organization as the Company grows, further advancing their leadership position.

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

Required Qualifications

• 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
• Psychiatry, Neurology, and Pain development experience, with a significant level of interaction with the relevant FDA review divisions highly preferred
• Experience working with the FDA is required. Global regulatory clinical trial experience and regulatory CMC experience are highly preferred
• 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
• Broad experience in a small company environment is a plus
• Ability to travel up to 25%

The starting base pay range for this position is $144,579.00 - $175,809.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 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!

Apply for this job

*

indicates a required field

First Name *

Last Name *

Preferred First Name

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Education

Degree * Select...

Select...

LinkedIn Profile

Website

Do you now, or will you in the future, require sponsorship to work in the US? * Select...