Aptuit is a company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators, offering a modern business strategy aimed at revolutionizing the entire process, from drug discovery through commercialization.

We are currently seeking a Manager for our Consulting division, to be based in our facility at Kansas City, MO. The Manager will provide management support to the Principal Consultant, Regulatory. Provides support on regulatory projects for clients and guidance on regulatory affairs issues to the Aptuit Consulting team and Aptuit operational staff. Assumes responsibility for assigned regulatory projects and leads project teams and manages staff and other resources to assure quality, completeness, accuracy, and timeliness. Interacts with regulatory authorities verbally and in writing as required by the project. Works collaboratively with the Aptuit Consulting team to assure the quality, completeness, and timeliness of regulatory documents and dossiers. A College degree in scientific or technical discipline with supervisory or managerial experience; advanced degree preferred.

Minimum of 6 years of experience managing preparation and submission of regulatory documents and dossiers as well as maintaining the submissions, e.g., INDs, CTAs, NDAs, CTDs, SPAs, Regulatory Meeting Information Packages, etc.; managing preparation of electronic submissions in eCTD format a plus.

Proven experience interacting with regulatory authorities in the form of verbal and written communications.

Demonstrated knowledge of current pharmaceutical regulations and guidance documents and the ability to interpret and apply them strategically.

Demonstrated skills in problem solving, analysis, project management, staff management, and interpersonal skills.

Good proficiency in computer skills, particularly using Microsoft Word and Adobe Acrobat.

Experience performing QA/QC reviews of regulatory documents.

Excellent verbal and written communication skills.

Sound organizational skills and ability to prioritize and manage multiple projects

Excellent attention-to-detail.

Able to work well independently as well as in a team environment.

To apply for this role please e-mail your cv stating the position applied for to CareersUS@aptuit.com

Aptuit offers a very comprehensive and competitive benefits program.
We are an Equal Opportunity Employer M/F/D/V