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.

Develop and direct a Boston-based Regulatory Affairs business and provide regulatory guidance to Aptuit Consulting and Aptuit operational staff. Provide management and strategic planning support to the Managing Directors and or practice leaders. Directs regulatory projects, leads project teams, and manages staff and other resources to assure quality, completeness, accuracy, and timeliness. Develops and implements regulatory strategies as required by project. Interacts with clients to assess their needs and to ensure their needs are met. Interacts with regulatory authorities verbally and in writing as well as participates in face-to-face regulatory authority meetings as required by the project. Identifies and pursues new regulatory business opportunities, meets with potential clients to assess their needs, issues proposals, and assists with development of marketing and presentation materials. Maintains expertise on all new and/or updated applicable industry, ICH, and regulatory standards, regulations, and guidelines with respect to regulatory requirements. Oversee development and updates to Aptuit Consulting standard operating practices, policies, and procedures. Works collaboratively with all Aptuit Consulting team members. As the business expands, this person may recruit, hire, manage, and mentor other regulatory staff.

College degree in scientific or technical discipline with proven regulatory management, organizational development, and strategic planning experience in a CRO or consulting capacity; advanced degree preferred.

Minimum of 15 years of experience managing preparation and submission of regulatory documents and dossiers as well as maintaining submissions, e.g., INDs, CTAs, NDAs, CTDs, SPAs, Regulatory Meeting Information Packages, etc.; managing preparation of electronic submissions in eCTD format a plus. Minimum of 8 years of experience in senior level regulatory affairs positions.

In-depth knowledge of drug development process and core strength in nonclinical, clinical, or CMC development.

Extensive experience developing and implementing regulatory strategies.

Proven experience interacting with regulatory authorities in the form of verbal and written communications as well as face-to-face meetings.

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

Ability to manage, motivate, and develop a team of regulatory affairs professionals.

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.

Excellent verbal and written communication skills.

Sound organizational skills and ability to prioritize and manage multiple projects in a dynamic environment.

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