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 timelines. They are accountable for 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. Periodically assess QMS against key regulations (e.g., GLP/GCP/GMP) and drive mitigation actions. Assess, revise, and maintain contracts, certifications, and other required agreements.

Compliance:
Ensure company policies, procedures, and practices comply with regulatory requirements. Review new business opportunities (expansion, contracts, etc.) to identify regulatory and quality requirements for implementation and the related effort/resources.

Documentation and Audits:
Oversee the preparation and submission of regulatory documents to health authorities or client notifications. Review audit responses for compliance with 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. Assess risk and determine actions required for HA notifications and other country-specific requirements. Continue to serve as Management Appointee for approval of Material Transfer Agreements 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. Support 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:
Stay current on global policies and guidelines related to regulatory requirements. Communicate potential changes and impacts proactively to internal stakeholders.

Training:
Deploy training programs to continually reduce the risk of non-compliance with regulatory guidelines. Provide regulatory intelligence and assessments to ELT, as well as general training to LC personnel regarding regulatory requirements.

Additional Duties:
Perform 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 and 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.

Required Skills

Proven leadership and supervisory ability.

Strong strategic thinking and problem-solving skills.

Strong analytical skills and ability to work effectively with the CQO as a strategic partner.

Ability to travel as needed.

Global work experience across cultures and time zones.

Ability to meet established timelines, processes, and procedures.

Excellent attention to detail.

Strong planning and problem-solving skills.

Self-motivated; able to work independently and collaboratively.

Adaptable to changing environments and requirements.

Ability to make quick, well-reasoned decisions.

Excellent organizational, time management, communication, multitasking, interpersonal, and listening skills.

Business acumen to drive a quality culture while meeting business goals.

Proficiency in Microsoft Word, Excel, and database software.

Join our team and discover how your work can impact patients’ lives around the world!

Some of the Perks Our LabConnectors Love

Financial security (base pay, 401k match, and possible annual bonus eligibility)

Health benefits beginning on date of hire

PTO plan, plus 11 paid company holidays and 1 day to volunteer in your community

Short- and long-term disability, life insurance, and AD&D

A culture that celebrates our differences

Career growth opportunities globally

A friendly, collaborative work environment guided by the values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always

We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate based on race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters

LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with the General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website at https://www.labconnect.com/

If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email [email protected]
or call +1 (423) 722-3155.

Learn more here