Director, Regulatory Strategy - FDA Products

DESCRIPTION

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

The Director of Regulatory Strategy for FDA Products will develop and execute regulatory strategies that drive business innovation while ensuring regulatory compliance. This role will provide leadership and guidance for regulatory submissions, health authority interactions, new product development, and existing product maintenance as well as oversee routine regulatory operations. The ideal candidate will combine strong regulatory knowledge with hands-on experience to ensure regulatory compliance over the full life cycle of a diverse portfolio of healthcare and consumer regulated drug, device, and cosmetics under FDA jurisdiction.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Contributions

• 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
• Regulation and Guidance:
• 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

Cross-Functional Support

• Collaboration: 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
• Problem Solving: 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

Operational Excellence

• 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

Mentorship and Collaboration

• Provide guidance and support to junior regulatory staff where applicable, sharing expertise and best practices
• Foster collaborative relationships internally and with external partners/sponsors

PERFORMANCE MEASUREMENTS

• Achievement: Consistent delivery of complete, accurate and on-time high-quality regulatory strategies and project deliverables
• Ownership: Independent and proactive management of assigned projects to ensure complete, accurate and timely completion
• Collaboration: Effective teamwork and communication across functions to achieve shared objectives
• Innovation: Introduction of creative solutions and contributions to process improvements and new product ideas
• Business Acumen: Effective balancing of compliance risk with commercial goals

QUALIFICATIONS:

EDUCATION/CERTIFICATION

• BS, MS, PhD, or PharmD degree in life sciences or pharmacy; RAC certification a plus

REQUIRED KNOWLEDGE

• 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

EXPERIENCE REQUIRED

• 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

DESIRABLES

• Experience in combination Drug + Device products a plus
• Experience in Cosmetics and OTC Monograph drugs a plus

SKILLS/ABILITIES

• 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

WORKING CONDITIONS

• Environment: Corporate office with on-site R&D laboratories
• Work Schedule: Hybrid (4-days/week onsite, 1-day/week remote)

SALARY RANGE

• $170,000 - $200,000 annually

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

• 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

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.