Associate Director / Director, Regulatory Systems

Larimar Therapeutics • Bala Cynwyd, PA

423d

About The Position

The Associate Director/Director of Regulatory Systems at Larimar Therapeutics Inc. is responsible for the implementation, validation, and management of regulatory systems. This role involves ensuring that these systems align with Regulatory Affairs requirements and collaborating with various stakeholders to address system issues and recommend process improvements. The position supports submission publishing and regulatory operations activities, contributing to the company's mission of developing treatments for rare diseases.

Requirements

• Minimum of a 4-year undergraduate degree.
• 8 - 10+ years of experience in a Regulatory Affairs system support role in the pharmaceutical industry.
• Understanding of GxP systems and quality principles.
• Ability to research global regulatory guidance and technical initiatives to assist in the development and execution of regulatory system strategies.
• Knowledge of eCTD structure, components, and basic regulatory operations in support of regulatory submissions.
• Experience with preparation (authoring and review) of documents for health authority submissions, including investigational new drug amendments and clinical trial submissions.
• Excellent communication, time management, and project management skills.
• Continuous quality improvement mindset and attention to detail.
• Ability to adapt to changing priorities and objectives in a fast-paced environment.

Responsibilities

• Implementation and validation of regulatory systems, including vendor management in collaboration with Quality operations and Information Technology.
• Administration of regulatory systems, including maintenance, user management, training, and issue escalation and resolution.
• Developing and maintaining standard operating procedures (SOPs) and work instructions (WIs) relevant to the use of regulatory systems.
• Ensuring compliance with SOPs and WIs, addressing deviations, and developing corrective and preventative actions related to regulatory systems.
• Providing support, training, and direction to end users.
• Delivering regulatory systems projects on time and on budget while ensuring day-to-day support meets business expectations.
• Assisting in developing the regulatory information management landscape and related roadmap.
• Designing, implementing, and disseminating standard, validated, and ad-hoc reports to meet compliance requirements.
• Managing the development of training materials, quick reference guides, and other reference documents to facilitate systems use.
• Managing change request development for regulatory systems and ensuring appropriate communication and business change management.
• Monitoring the development of new regulatory requirements or guidance regarding regulatory systems and recommending system changes as appropriate.
• Leading upgrades and maintenance of regulatory systems, including validation activities.
• Communicating system status and maintenance activities and liaising with IT and vendors for support.

Benefits

• Incentive stock options
• Comprehensive benefits plan including 401K
• Flexible PTO policy

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 11-50 employees