Director, Regulatory Affairs
BioSpace, Franklin Park, NJ, United States
Overview
Tris Pharma, Inc. is a privately-owned US biopharmaceutical company focused on development and commercialization of medicines in ADHD, spectrum disorders, anxiety, pain and addiction. We license products in US and ex-US markets and maintain a pipeline spanning neuroscience and other therapeutic categories. We seek to hire an experienced Regulatory Affairs Director in Monmouth Junction, NJ to support a 505(b)(1) New Chemical Entity (NCE) NDA for a late-stage biotech program. The role is hands-on and execution-focused, with responsibility for day-to-day NDA submission management and delivery. The candidate will function as the Regulatory Affairs Lead's operational right-hand, owning NDA module preparation, driving cross-functional execution, and ensuring high-quality, on-time NDA submission. This role suits regulatory professionals who thrive in lean biotech environments, are comfortable with ambiguity, and can balance strategic input with tactical execution. 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, and response planning to information requests. 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, and 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: Act 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
Bachelor’s degree in science or a related discipline (Advanced degree preferred) and minimum 10 years Regulatory Affairs experience in pharmaceutical/biotechnology or related industry with increasing technical and strategic responsibility. Current hands-on experience supporting or leading 505(b)(1) NCE NDA submissions. Proven experience authoring, reviewing and managing NDA modules (not strategy-only). Strong working knowledge of FDA regulations, guidance and eCTD requirements. Ability to operate effectively in a small biotech setting with limited infrastructure. Experience interacting with FDA’s Analgesia/Pain Division (DAAAP or successor) preferred. Background in pain, CNS or controlled substance programs preferred.
Work Arrangements
Hybrid work environment; candidates should be able to work the majority of the week in our NJ office. Compensation and Benefits
Anticipated salary range: $200k to $245k per year. Base salary offered is contingent on candidate’s education and experience relative to requirements and industry standards. Additional benefits include medical, dental, vision, Rx insurance, 401(k) 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. We encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ+ and other diverse groups. Tris Pharma, Inc. is an Equal Opportunity Employer.
#J-18808-Ljbffr
Tris Pharma, Inc. is a privately-owned US biopharmaceutical company focused on development and commercialization of medicines in ADHD, spectrum disorders, anxiety, pain and addiction. We license products in US and ex-US markets and maintain a pipeline spanning neuroscience and other therapeutic categories. We seek to hire an experienced Regulatory Affairs Director in Monmouth Junction, NJ to support a 505(b)(1) New Chemical Entity (NCE) NDA for a late-stage biotech program. The role is hands-on and execution-focused, with responsibility for day-to-day NDA submission management and delivery. The candidate will function as the Regulatory Affairs Lead's operational right-hand, owning NDA module preparation, driving cross-functional execution, and ensuring high-quality, on-time NDA submission. This role suits regulatory professionals who thrive in lean biotech environments, are comfortable with ambiguity, and can balance strategic input with tactical execution. 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, and response planning to information requests. 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, and 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: Act 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
Bachelor’s degree in science or a related discipline (Advanced degree preferred) and minimum 10 years Regulatory Affairs experience in pharmaceutical/biotechnology or related industry with increasing technical and strategic responsibility. Current hands-on experience supporting or leading 505(b)(1) NCE NDA submissions. Proven experience authoring, reviewing and managing NDA modules (not strategy-only). Strong working knowledge of FDA regulations, guidance and eCTD requirements. Ability to operate effectively in a small biotech setting with limited infrastructure. Experience interacting with FDA’s Analgesia/Pain Division (DAAAP or successor) preferred. Background in pain, CNS or controlled substance programs preferred.
Work Arrangements
Hybrid work environment; candidates should be able to work the majority of the week in our NJ office. Compensation and Benefits
Anticipated salary range: $200k to $245k per year. Base salary offered is contingent on candidate’s education and experience relative to requirements and industry standards. Additional benefits include medical, dental, vision, Rx insurance, 401(k) 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. We encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ+ and other diverse groups. Tris Pharma, Inc. is an Equal Opportunity Employer.
#J-18808-Ljbffr