Associate Director of Regulatory Affairs

JOB LOCATION/SCHEDULE: 

Monday – Friday / On-Site / Irving, TX

COMPANY OVERVIEW: At Alliance Clinical Network we’re people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research. We bring our energy and our passion to improving patient lives every day.

SUMMARY: The Associate Director of Regulatory Affairs is responsible for managing the efficient execution of all regulatory functions across multiple clinical trials, providing strategic direction, resource allocation, and leadership to the regulatory team. The Associate Director will play a pivotal role in ensuring compliance with regulatory requirements and in supporting the timely execution of study deliverables.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Comply with all company policies, procedures, and conduct.
• Strictly adhere to confidentiality and compliance standards.
• Lead, mentor, and manage a team of regulatory associates to ensure high-quality regulatory support for clinical trials. Provide guidance on regulatory processes, workload management, and performance optimization.
• Provide strategic direction, set performance goals, and foster a collaborative team environment.
• Oversee and allocate resources effectively across trials to meet regulatory submission deadlines and project needs, ensuring that the team is adequately staffed and equipped to handle workload fluctuations.
• Develop and implement regulatory strategies in line with local, regional, and international regulations, ensuring compliance with GCP, FDA, EMA, and other relevant authorities.
• Oversee the preparation, review, and submission of essential regulatory documents such as INDs, CTAs, amendments, annual reports, and responses to regulatory agency queries.
• Collaborate with clinical operations, project management, and quality teams to align regulatory activities with study timelines and objectives, proactively addressing potential bottlenecks.
• Identify training needs and develop programs to enhance the regulatory associates' knowledge, skills, and competencies in regulatory affairs.
• Continuously assess and improve regulatory processes to optimize efficiency, quality, and compliance, implementing best practices where necessary.
• Stay updated on regulatory changes and trends in the clinical research landscape to inform decision-making and strategic planning.
• Identify and mitigate regulatory risks associated with clinical trials, ensuring proactive measures are in place to address potential compliance issues.
• Meet assigned targets, goals and completion deadlines.
• Utilize analytical, problem solving and critical thinking.

QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and EXPERIENCE:

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field (Master’s degree preferred).
• Minimum of 8 years of experience in regulatory affairs within the clinical research industry, with at least 3 years in a leadership management role.
• Strong understanding of clinical trial processes, GCP, FDA regulations, and electronic data capture technologies.
• Experience managing teams and cross-functional collaboration, with a proven ability to lead and motivate site staff in a fast-paced environment.
• Excellent communication, project management, and problem-solving skills.
• Knowledge of financial principles and experience working with study budgets is highly desirable.
• Strong attention to detail.
• Must be able to prioritize competing demands.
• Must possess excellent verbal and written communication skills.
• A proven ability to multi-task in a rapidly changing environment.

 BENEFITS:

• 401 (k) Retirement Plan
• Medical, Dental, and Vision Insurance
• Paid Time Off (PTO)
• Floating Holidays

• And more!