Director, Regulatory Affairs

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!

**No calls or emails from third-party vendors or agencies will be accepted.**

POSITION PURPOSE

To support and maintain PDI's strategic business objectives through product registrations, registration maintenance, supplements for drug and EPA regulated products in the United States and Canada. Will ensure full regulatory compliance with applicable Guidelines, Federal and State regulations regarding products, labeling, advertising and promotional materials, registration and listings, and relevant policies, and practices.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

The primary role of the Director, Regulatory Affairs, is to lead the Drug and EPA regulated product cycle management. He/ she will map and lead the execution of the optimal and contingent regulatory pathways for all stages of the product lifecycle for domestic and international distribution.

LEADERSHIP & MENTORING

• Lead, direct and influence the PDI Regulatory team to support and develop regulatory strategy for new products to grow and expand the PDI business and product line.
• Lead and influence internal cross functional teams to ensure the necessary scientific data, Product claims, collaterals, and documentation are available in a timely manner to support regulatory filings.
• Convey critical knowledge, especially relating to assigned products, to alleviate or reduce regulatory impacts and risk.
• Train and mentor direct reports and Regulatory Affairs Associates to support their development and growth.
• Represent regulatory affairs in cross functional teams to provide timely and accurate regulatory guidance.

DATA ENTRY & INTEGRITY:

• Prepare and review Regulatory protocols and reports for non-clinical, clinical, and toxicological studies
• Lead the Regulatory activities for drug development: from pre-IND planning, IND submission including CTAs through DMF/NDA/MAA submission, approval and commercialization
• Lead the Regulatory activities for EPA regulated products: from pre-planning, submission including EPA & state approvals and commercialization

REPORTING & ANALYSIS:

• Conduct effective budgeting analysis and forecasting to support robust Regulatory organization and short-term, medium-term and long-term projects
• Provide project management for multiple Regulatory pathways, including optimal and contingent paths.
• Develop departmental metrics to measure and improve effectiveness.

CLIENT ENGAGEMENT:

• Help drive innovation by developing relationships with Regulatory Authorities to understand how to maximize our investments through the regulatory process
• Develop and maintain strong, collaborative internal partnerships (e.g., R&D, Quality, Legal, Marketing, Operations, Clinical Affairs) to facilitate workflow and information sharing.
• Lead the expansion of visibility of the Regulatory Affairs Team to effect positive culture change throughout the Enterprise.

TECHNICAL EXPERTISE:

• Industry expertise in domestic and international regulations, including FDA, EPA, EMA, ICH, Health Canada as well as expert understanding of trends and Agency direction.
• Scientific expertise in the non-clinical, clinical, toxicological, EPA, FDA and operational (CMC) areas.
• Proficiency with electronic submissions/ Regulatory filing systems. (EPA & FDA)
• Develop, influence, and implement regulatory strategies to obtain approval for new or modified products and to support existing product lifecycle and registrations.
• Plan, coordinate and maintain existing IND, NDA and 510(K)s registrations including Supplement (CBE, CBE-30, PAS) & Annual Reports and prepare 510(k) filings for new products
• Maintain compliance with all regulatory requirements for products that fall under FDA & EPA jurisdictions.
• Interact with and influence regulatory agencies to obtain timely approval of in process applications by providing timely and accurate answers to deficiencies or questions.
• Ensure project and submission timelines are met by establishing meetings, tracking documentation status, planning publishing, anticipating delays, and mitigating risk
• Facilitate favorable regulatory outcomes through establishing appropriate internal and external meetings, advising on appropriate data generation, negotiation of requirements, labeling and risk mitigation strategies.

REGULATORY COMPLIANCE/INTELLIGENCE

• Participate in Trade Associations and influence Regulatory Agenda to protect PDI's interest and products.
• Maintain strong knowledge of current Guidance and regulations related to Drugs and Medical Devices, in addition to general regulatory knowledge.
• Perform impact assessment for new requirements and implement compliance plan.
• Experience with eCTD submissions and eCTD format is desirable.
• Ensure that product labeling, claims, and advertising materials follow applicable country laws and regulations.
• Support pharmacovigilance activities by reviewing adverse events to determine reporting obligation.
• Support Quality activities, including internal and external audits, and by reviewing CAPAs, OOS and Nonconformance.
• Review Change Controls and perform impact assessment to identify any regulatory actions.
• Implement process improvement projects, including writing new SOPs and Work Instructions.
• Review new raw materials to ensure compliance with all applicable requirements, including, FDA's OTC monographs, CA Prop 65, Canada DSL, and Hotlist.
• Review and approve technical documents (e.g., stability protocols, product specifications) and safety reports (APRs and PBRERs) to ensure accuracy and compliance with applicable requirements.

SPECIAL PROJECTS:

• Analyze Organization for capabilities in accordance with Strategic Plan
• Participate in Agency Inspections and audits
• Develop, implement, and review Policies and Procedures for Regulatory Affairs processes and tasks.

PERFORMANCE MEASUREMENTS

• Successful mapping of Regulatory pathways for active projects
• Agency approval of submissions - single cycle
• Effective budget analysis and execution
• Employee development and engagement
• Team Development
• Lead cross-functional teams

QUALIFICATIONS

EDUCATION/CERTIFICATION

• A minimum of a BA/BS within a scientific discipline is required.
• Advanced/ terminal degree such as MS, PhD or PharmD is a plus.

REQUIRED KNOWLEDGE

• Proficiency in electronic submissions/ electronic filing systems, Microsoft Office/ Lync, SharePoint required.

EXPERIENCE REQUIRED

• 10-plus years of applicable experience in the regulatory affairs environment
• At least 5 years of management experience leading professionals.
• A strong background in pharmaceutical product Quality management.
• A strong background in EPA regulated product Quality management.

SKILLS/ABILITIES

• Expertise to strategize, execute, develop and improve regulatory systems for compliance and efficiency
• Ability to react calmly, thoroughly and quickly in urgent situations.
• Leadership that is inspirational and collaborative

WORKING CONDITIONS

• No hazardous or significantly unpleasant conditions.

SALARY RANGE

• $180,000 - $190,000 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.