Senior Regulatory Affairs Manager

Veristat•California, CA

2d•$125,000 - $160,000

About The Position

The Senior Regulatory Affairs Manager manages assigned regulatory and cross-functional projects and provides strategic and operational support to Veristat clients in regulatory decision-making, healthcare product filings, and product maintenance. The role provides consultation to clients, translating regulatory requirements into practical applications that support clinical trials and regulatory submissions. The manager works with project teams, advises on regulatory agency interactions, manages agency communications, supports submission preparation, and builds strong client relationships.

Requirements

Bachelor’s degree in a related field.
Six to eight years of regulatory affairs experience in a clinical research organization and/or pharmaceutical setting, or demonstrated ability to function at this level.
Proven track record of global regulatory submissions.
Thorough knowledge of ICH guidelines and regulatory guidelines in relevant territories, as well as drug development, clinical trials, and clinical research.
Excellent written and oral communication skills, including grammatical and technical writing skills.
Familiarity with drug development, agency interactions, study designs, and regulatory requirements applicable to clinical trials.
Demonstrated ability to develop and foster positive client relationships.
Demonstrated ability to lead by example and provide technical leadership to staff.
Skilled in Microsoft Word and Microsoft Excel, with the ability to learn new applications.
Excellent interpersonal, communication, and organizational skills, and the ability to work independently and in a team environment.

Nice To Haves

Advanced scientific degree, such as a PhD or master’s degree.
For the Senior Manager Regulatory Affairs CMC specialization: familiarity with manufacturing, specifications, analytical testing, and overall regulatory CMC requirements.

Responsibilities

Manage assigned regulatory and cross-functional projects.
Provide strategic and operational support to clients in regulatory decision-making, product filings, and product maintenance.
Consult with clients and translate regulatory requirements into practical applications for clinical trials and regulatory submissions.
Work with project teams and advise on regulatory agency interactions.
Manage communications with regulatory agencies.
Support the preparation of regulatory submissions.
Build and maintain strong client relationships.
Provide technical leadership to staff and lead by example.