PDI · 13 hours ago
Director, Regulatory Strategy - FDA Products
Woodcliff Lake, New Jersey, United States
Full-time
Hybrid
Director/Executive
$170K/yr - $200K/yr
10+ years expPDI is a company dedicated to providing innovative products and resources to prevent infection transmission and promote health. They are seeking a Director of Regulatory Strategy for FDA Products to lead regulatory strategies for new product development and ensure compliance with FDA regulations throughout the product life cycle.
Medical DeviceEducationHealthcareHealth CareMedicalTraining
Responsibilities
Lead FDA Products Regulatory team in developing and executing regulatory strategies for new product development, business development & licensing opportunities, and post-marketing changes to ensure successful commercialization across product life cycle
Prepare, submit and maintain new IND/NDA, and 510(k) marketing authorization applications
Develop and maintain strong relationships with FDA project managers
Represent Regulatory Affairs in cross-functional new product development (NPD) teams
Develop and maintain strong, collaborative partnerships with R&D, Clinical, Quality, Legal Marketing, Operations and Project Management
Prepare regulatory pathway options, identify project risks and support project teams in risk mitigation strategies
Identify, communicate and provide support to R&D, Clinical, Quality and other functions in interpretation and application of relevant guidance and regulation
Lead and influence cross-functional teams to ensure technical data and information is accurate, complete and on-time to meet submission timelines
Review and approve technical documents (protocol, reports, specifications) to ensure complete, accurate and in compliance with relevant regulations
Review change controls to assess reportability
Author and review regulatory documents for IND, NDA, and 510(k) submissions
Prepare, submit and maintain ARs for FDA IND and NDA drug products
Support Pharmacovigilance in assessing reporting requirements for AEs, review and submit PADERs and PBRERs
Maintain complete and accurate IND, NDA, 510(k) chronology logs and documentation
Collaborate with cross-functional team in the review and approval of labeling, advertising and promotional material
Monitor trends, emerging regulations, guidance, and best practices related to product development and compliance
Translate regulatory intelligence and trends into proactive, actionable guidance
Represent PDI at industry meetings
Ensure products meet all relevant Federal regulations and reporting requirements for U.S. and CA
Train, mentor, and oversee 1 direct report
Assist in Agency inspections and audits as necessary
Work closely with multidisciplinary teams, including R&D, Clinical, Operations, and Quality functions to integrate regulatory requirements into the overall drug development strategy, align regulatory submissions with development and operational plans, and ensure project timelines are met
Generate hypotheses and investigative strategies to address product development or compliance challenges
Participate in health authority interactions (FDA, Health Canada) by preparing meeting materials and response strategies
Maintain and strengthen regulatory documentation, templates, and SOPs to support consistent, high-quality regulatory assessments and strategies
Partner with cross-functional colleagues to identify process improvements and leverage tools that enhance efficiency and accuracy in development and maintenance projects
Provide guidance and support to junior regulatory staff where applicable, sharing expertise and best practices
Foster collaborative relationships internally and with external partners/sponsors
Qualification
Required
BS, MS, PhD, or PharmD degree in life sciences or pharmacy; RAC certification a plus
Significant knowledge and working experience in drug development, submissions and FDA interactions
Significant knowledge of 21 CFR 312/314, 21 CFR 820, cGMPs, QSRs, FDA Guidance and best practices in drug and device development and maintenance
10 -12 years of FDA regulatory experience in drug and medical device development and approval/clearance processes
Demonstrated experience in developing and executing regulatory strategies for new drugs and medical devices
Demonstrated experience in obtaining approval for new drugs via the IND/ NDA pathway
Demonstrated experience in obtaining clearance for 510(k) medical devices
Experience preparing and leading meetings with FDA
Strong organizational skills with attention to detail, quality, and timelines
Excellent written and verbal communication skills; ability to work in cross-functional teams
Excellent organizational, prioritization abilities, tracking and follow-up skills
Ability to complete projects on time and handle multiple parallel projects in a fast-paced environment
Good analytical and problem-solving abilities, communication and interpersonal, and record keeping skills
Strong attention to detail
Ability to handle multiple tasks / projects simultaneously and bring them to completion on time
Self-starter with ability to think and act independently and to make sound decisions
Fast learner with a flexible style and the ability to adjust to changing business priorities
Ability to interface with internal and external contacts at all levels
Great flexibility and ability to work well with shifting priorities
Preferred
Experience in combination Drug + Device products a plus
Experience in Cosmetics and OTC Monograph drugs a plus
Benefits
Medical, behavioral & prescription drug coverage
Health Savings Account (HSA)
Dental
Vision
401(k) savings plan with company match and profit sharing
Basic and supplemental Life and AD&D insurance
Flexible Spending Accounts (FSAs)
Short & long-term disability
Employee Assistance Program (EAP)
Health Advocacy Program
Legal services
Critical illness
Hospital indemnity
Accident coverage
ID theft and fraud protection
Pet insurance
Employee discounts
Sick & safe leave
Vacation
Company & floating holidays
Paid parental leave
Summer hours
Flex place/flex time options
Company
PDI
PDI is dedicated to leading the fight against preventable infections in healthcare, foodservice and our communities.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Tony Cerasuolo
Chief Financial Officer
Diane Powell
Executive Assistant to CEO
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