USA/Remote

Key Responsibilities:

• Provide strategy for rapid and timely approval of new products and regulatory support for clinical products globally–early identification of regulatory challenges throughout clinical development.

• Assist in planning, writing, and reviewing Health Authority document submissions.

• Provide recommendations based on US and international (including EU and Asia) regulatory policies, standards and expectations to ensure a fair balance of business and regulatory risk.

• Know, understand, incorporate and comply with all applicable laws and regulations relating to business activities.

• Design and drive Quality Assurance systems and processes to assure regulatory compliance for disposition and releasing of drug substances and drug products, managing regulatory inspections, handling drug complaints, leading investigations to resolve Quality issues and conducting document change control.

• Design and oversee the execution of cGXP and SOP training programs.

• Provide regulatory strategy for manufacturing/design transfer activities.

• Provide leadership and guidance on the latest requirements, standards and trends within the company and industry. The individual evaluates changes for regulatory impact and develops policies and requirements for Regulatory systems in order to minimize compliance risk.

• Interact with regulatory agency personnel in regard to current approvals and any proposed changes to regulations. Proactively influence regulatory policies and implement processes to ensure Company maintains market status. The individual will be an active member of industry associations.

• Develop and mentor Regulatory and Quality personnel and future Regulatory/Quality leaders, and manage the department budget.

• Oversee Quality to assist in management of external inspections/assessments of facilities.

• Serve as the Regulatory and Quality representative on project teams and manage relationships with counterparts within Service Provider organizations.

Requirements:

• A minimum of a B.A./B.S. within a technical related discipline is required. M.S., M.E., Ph.D. or M.D. is a plus.

• At least 15 years relevant / regulated industry experience is required.

• Leadership experience is required, including line management of multiple levels of reporting. Compliance, auditing experience is a plus. Pharmaceutical experience required. Experience working in liver disease, gastrointestinal disease and/or metabolic disorders is a plus. Experience working with professional and trade associations is a plus.

• Ability to lead cross-company and cross-franchise teams to meet common business objectives.

• Ability to manage and resolve complex domestic and international regulatory issues.

• Ability to utilize regulatory and quality experience to create and execute worldwide vision and strategies.

• Ability to apply superior technical writing skills to job duties and tasks.

• Ability to effectively communicate using both oral and written communication skills.

• Ability to prioritize and handle multiple projects simultaneously.

Ability to apply high level of ethics.

Contact

careers@hightidetx.com