Leading the Regulatory Affairs and Compliance functions, this role will generate the preparation of submissions to obtain and maintain approvals for commercially distributing products within the US. Provide leadership and direct activities to ensure compliance with U.S. regulatory requirements.
The key to this role will be a deep understanding of the US Food and Drug Administration (FDA), regulatory processes and expectations.
Job Responsibilities:
The Director will ensure the appropriate licensing, marketing and legal compliance of all appropriate medical products in order to control the safety and efficacy of the products.
Work closely with the Ascend team to define and execute on the optimal regulatory submissions and approval pathway.
Ensure Ascend's products comply with the regulations of all applicable regulatory agencies.
Stay current and apprised of changing U.S. legislation, guidelines and customer practices.
Develop and write clear processes for Regulatory approvals.
Oversee submissions of license variations and renewals.
Monitor and set timelines for license variations and renewal approvals.
Work with marketing to approve commercial literature and language.
Review company practices and provide advice on changes to systems.
Keep abreast of new or developments in various regulations and advise senior management as necessary.
Supervise the creation of Ascend's SOPs.
Oversee the compliance training and educational programs for employees
Design and conduct health care compliance auditing program including audits of Sales Reps and our speaker program
Upon completion of audits, recommend resolution of compliance issues and ensure integrity of the compliance program
Consult with management on potential compliance risk areas
Conduct internal investigations, as necessary, and document investigation steps, findings, and remedial actions
Minimum qualification:
10 - 15 years of experience in the area of U.S. regulatory affairs (both submissions and compliance) at pharmaceutical or medical device companies.
Minimum of B.S. degree in a scientific discipline or engineering required.
Advanced degree preferred.
Ability to manage all budgetary responsibilities
Ability to travel domestically and internationally to up to 30% or more of the time
Other Job Specific Skills:
Good working knowledge of U.S. FDA, regulations and standards.
Excellent interpersonal, communication (written and oral), teamwork, leadership, organizational and negotiating skills.
RA certification (by Regulatory Affairs Professional Society) is a plus.
Familiar with manufacturing techniques, project management and formal continuous process improvement techniques.
Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including the Anti-Kickback Statute, False Claims Act, FCPA, PhRMA Code, OIG Guidance, FDA Regulatory Guidelines, FCPA, Federal Sunshine act, state marketing disclosure laws, and state price reporting statutes