"Alerted.org

General Description:

The Senior Director, Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive regulatory strategies to ensure compliance with global health authorities. This role involves leading and overseeing all aspects of regulatory and clinical quality event investigations, quality management reporting, and regulatory audits and inspections.

The ideal candidate will have extensive experience managing investigations, serious breach evaluations, and directing regulatory inspections and responses. This individual will be responsible for developing and optimizing technology to support regulatory and clinical quality events, CAPA, and planned deviations, including the reporting of trends and metrics across the development pipeline.

The Senior Director will guide and support the timely review of quality events, summaries for inclusion in appropriate submissions, metrics for management review, and inspection readiness activities.

Essential Functions of the job:

+ Ensure the organization adheres to all relevant laws, regulations, and guidelines, keeping abreast of changes in regulations and standards that may affect the organization and advising on necessary adjustments to policies or practices.

+ Develop and implement compliance strategies, analyze data and information to identify compliance issues and trends. This includes conducting risk assessments and internal audits.

+ Drive the implementation of new processes with clinical quality, compliance, study teams, and cross-functional SMEs to ensure appropriate and timely documentation of quality event management, including CAPA plans, notification to management, and serious breach reporting.

+ Lead the development of new/improved processes within Veeva to optimize reporting and oversight of Quality Events, evaluate and enhance the tools used for Quality Events and Planned Deviations

+ Oversee the reporting of Quality Events and Planned Deviations for regulatory submissions, Inspection Readiness, and Inspection teams, as necessary.

+ Develop and implement internal regulatory compliance processes and procedures to ensure compliance.

+ Maintain accurate records of compliance activities, and correspondence with regulatory authorities, and prepare reports for leadership and internal stakeholders.

+ Provide training to employees on compliance matters and communicate regulatory changes.

+ Guide and mentor individuals involved in the reporting and processing of quality events supporting GCP quality and compliance.

Knowledge, Skills, and Experience:

+ Bachelor’s degree required.

+ 12+ years’ experience in positions of increasing responsibility in Regulatory Compliance and/or clinical (GCP) quality assurance

+ Experience leading complex quality investigations and planned deviations.

+ Experience with vendor audits, and internal process audits.

+ Proven experience in the preparation and facilitation of regulatory audits and inspections.

+ **Strong Knowledge of Regulations:**  In-depth understanding of relevant laws, regulations, and industry standards. ICH-E6 GCP, US FDA, EMA and Global regulations and guidance documents supporting clinical quality and compliance.

+ **Analytical Skills:**  Ability to analyze data and information to identify compliance issues. Demonstrate experience interpreting regulations into real-world applications.

+ Leader who can anticipate issues and bottlenecks and resolve issues effectively with minimal oversight.

+ **Communication Skills:**  Ability to communicate effectively with various stakeholders, including management and regulatory agencies. Ability to communicate effectively with people in diverse and different settings.

+ **Organizational Skills:**  Ability to manage multiple tasks and projects effectively. Well organized, detail oriented, and able to prioritize and manage multiple projects at one time.

+ **Software Proficiency:**  Proficiency in relevant software and systems, such as compliance management platforms

+ **Problem Solving:**  Addressing compliance issues and developing solutions.

+ **Attention to Detail:**  Ability to pay close attention to detail and ensure accuracy.

Supervisory Responsibilities:

+ Yes

Computer Skills:

Working knowledge of:

+ Microsoft Office and Adobe systems

+ Document management systems (Veeva Vault, OpenText, SharePoint, etc.)

+ Regulatory Information management systems (Veeva Vault, Liquent InSight, etc.)

+ Collaboration Tools (SharePoint, etc.)

Other Qualifications:

+ Excellent written and visual communication skills

+ Excellent presentation and facilitation skills

+ Working knowledge of regulations, processes and industry standards that govern regulated systems, records retention, and computer validation quality assurance for the management of regulatory-focused content, throughout the product lifecycle stages, SDLC methodologies and CFR Part 11 and Annex 11 compliance.

+ Knowledge of drug development and submission requirements

+ Demonstrated ability to facilitate, lead and manage the establishment of procedures. Able to work in a fast-paced environment and effectively manage workload and deliverables under pressure.

+ Able to work in a fast-paced environment and effectively manage workload and deliverables under pressure.

**Travel:** <35%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.