Director, Regulatory Affairs

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

Our science and technology make us unique, but our team members set us apart; they’re the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

We have an opening in our Monmouth Junction, NJ offices for an experienced Regulatory Affairs Director to support a 505(b)(1) New Chemical Entity (NCE) NDA for a late-stage biotech program. The individual contributor role is highly hands-on and execution-focused with responsibility for day-to-day NDA submission management and delivery. You will function as operational right-hand to the Regulatory Affairs Lead, owning NDA module preparation activities, driving cross-functional execution, and ensuring high-quality, on-time NDA submission.

This role is well-suited for a regulatory professional who thrives in lean biotech environments, is comfortable working with ambiguity and can seamlessly shift between strategy input and tactical execution.

Key Responsibilities

NDA Strategy Execution

• Support Regulatory Affairs Lead in implementing regulatory strategy for 505(b)(1) NCE NDA
• Provide pragmatic, experience-based regulatory input informed by recent FDA interactions and division expectations, particularly in analgesia/pain
• Contribute to FDA meeting preparation (mid and/or late-cycle) including briefing documents, questions, response planning to IRs, etc.
  
  
  

Hands-On NDA Submission Management

• Day-to-day driver of NDA submission activities, managing timelines, dependencies and deliverables
• Lead and/or directly support preparation, integration, review of NDA Modules 1–5
• Ensure submission content is clear, consistent, inspection-ready (manage communications with QA) and aligned with FDA expectations
  
  
  

Cross-Functional Leadership in a Lean Environment

• Acts as Regulatory execution point alongside Regulatory Lead across Clinical, CMC, Nonclinical, Biostatistics, Medical Writing, Labeling and external partners
• Drives content planning and readiness, proactively identifying risks and proposing solutions
• Provides oversight of technical publishing, QC activities and final eCTD submission assembly
  
  
  

Review, Quality, FDA Interactions

• Perform detailed regulatory reviews ensuring compliance with FDA regulations, guidance and internal standards
• Support responses to FDA information requests during filing review and post-submission
• Assist with labeling development and negotiation support, as appropriate for program stage.
• Support documentation and team preparation/practice for potential Advisory Committee Meetings
  
  
  

Requirements

Required Qualifications

• Bachelors degree in science or a related discipline (Advanced degree PREFERRED) and minimum 10 years Regulatory Affairs experience in the pharmaceutical, biotechnology or related industry in positions of increasing technical and strategic responsibility REQUIRED
• Current hands-on experience supporting or leading 505(b)(1) NCE NDA submissions REQUIRED
• Proven experience authoring, reviewing and managing NDA modules (not strategy-only) REQUIRED
• Strong working knowledge of FDA regulations, guidance and eCTD requirements REQUIRED
• Ability to operate effectively in a small biotech setting with limited infrastructure REQUIRED
• Experience interacting with FDAs Analgesia/Pain Division (DAAAP or successor) PREFERRED
• Background in pain, CNS or controlled substance programs PREFERRED
  
  
  

Work Arrangements: We are a HYBRID work environment requiring candidates to be able to work majority of week in our NJ office.

Anticipated salary range: $200 to $245K/yr. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.