Director, Regulatory Affairs - Quality & Regulatory Systems

Overview

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.


Role Overview:

The Director, Regulatory Affairs will lead the strategic development and implementation of regulatory strategies and frameworks to ensure compliance with global regulations. The individual is recognized as a key advisor and resource in regulatory intelligence, processes and compliance.

This position is responsible for coordinating operational aspects of implementing Regulatory strategy and intelligence into LC business that will contribute to managing Regulatory Affairs and ensuring global Regulatory Compliance.

This leadership role plans, prepares, and monitors regulatory documents and/or quality documents and communications ensuring conformance with global regulatory requirements, client expectations, guidelines, internal standards and timeline. They are accountable in ensuring LC complies with applicable global and local HA requirements and standards.
General responsibilities include but are not limited to:

Responsibilities:

• Regulatory Strategy: Develop and implement competitive and effective global regulatory strategies for products and services, including clinical, nonclinical, and CMC aspects. Periodic assessment of QMS against key regulations (e.g GLP/GCP/GMP) and driving mitigation actions. Assess, revise and maintain contracts, certifications and other required agreements.
• Compliance: Ensure company policies, procedures, and practices comply with regulatory requirements. Reviews new business opportunities (expansion, contracts etc) to identify the regulatory and quality requirements for implementation and related effort/resources.
• Documentation and Audits: Oversee the preparation and submission of regulatory documents to health authorities or client notifications. Reviews audit responses for compliance to regulations where needed. Support Client and/or vendor audits when needed.
• Agency/client Interaction: Serve as the primary liaison with regulatory agencies or clients (where impacted), including leading meetings and negotiations. Assesses risk and provides actions required towards HA notifications and other requirements on critical issues, trade and country specific requirements. Continue to serve as Management appointee for approval of Material transfer agreement and Data privacy agreements
• Risk Management: Identify potential risks associated with regulatory strategies and propose mitigation plans. Embed QRM (quality risk management) into programs, policies, and initiatives and report on it. Supports Quality issue resolution in QMS to ensure compliance.
• Continuous Improvement: Support continuous improvement efforts across the company helping LabConnect adapt to changing market expectations and maintain a competitive edge. Create, monitor and report on Regulatory intelligence, including new regulations and their impact on LC activities. Initiate changes to LC QMS where needed. Lead and implement higher Quality standards to establish LC as best in class.
• Subject Matter Expert: Keep abreast of global policies and guidelines as they relate to regulatory policies and communicate potential changes and impacts proactively to internal stakeholders.
• Training: Deploy training programs to continually reduce the risk of non-compliance with regulatory guidelines. Develop and provide regulatory intel and assessments to ELT as well as general training to LC personnel related to regulatory requirements.
• Performs other related duties and tasks as necessary or as assigned, including audits, client presentations and QE reviews

Education and Qualifications:
• Education: Bachelor's degree in a relevant field; advanced degree preferred. Central lab services experience, Biotech/Pharma experience required.
• Experience: 10+ years of progressive experience in quality and regulatory affairs within the biotechnology/pharmaceutical industry. Thorough knowledge of GCP. GLP, GDP global standards and regulations required. Must have global regulatory experience with submissions/approvals/licensure and industry standards
• Certifications: RAC (Regulatory Affairs Certification) or equivalent preferred.