Manager/Senior Manager, Regulatory Operations and Systems

Position Description:

Manages the publishing, transmittal, and archiving of regulatory correspondence and submissions in both electronic (eCTD) and hard-copy formats, in compliance with current and emerging regulatory requirements. Also manages the technological systems and processes of Regulatory Affairs and supports the management of global labeling, as appropriate.

Essential Functions:

Assigns and manages the Regulatory Operations teams responsible for publishing and archiving regulatory submissions and correspondence.

Trains, mentors, and develops Regulatory Operations staff.

Ensures compliance of submissions with all applicable regulations, guidances, SOPs, and internal document specifications for regulatory submissions, including eCTD, SPL/PLR, and ESG.

Serves as the authority and provides guidance and training to submission authors and publishing staff on the planning, preparation, processes, and timelines for regulatory submissions.

Resolves project team issues related to the timelines and processes for regulatory submissions publishing.

Provides expertise to project teams regarding electronic (eCTD) submissions and submission technical issues.

Determines the need for contract publishing services (both vendors and temporary staff) as well as the expertise required; oversees the selection and management of external vendors and in-house temporary staff.

Manages the development, writing, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation.

Manages the regulatory archives, electronic files, and communications databases.

Interprets and applies new and revised regulatory guidance for the format and transmittal of electronic submissions and labeling.

Serves as Cubist’s primary point of contact with regulatory authorities regarding technology issues.

Evaluates, implements, tests, and administers regulatory computer systems, including publishing, transmittal, and archival technologies for electronic regulatory documentation.

Creates functional specifications for regulatory computer applications based on regulatory business processes and user needs; assesses validation requirements in cooperation with IT and approves validation and user documentation.

Coordinates with IT staff and with vendors as needed to resolve technology problems encountered by users of regulatory systems.

Supports global filing and labeling activities as appropriate.
Required Skills:

Education: Bachelor's degree in a relevant discipline

Expertise in CTD/eCTD format and regulatory submission requirements

Fluency in document publishing tools (e.g., Microsoft Office and Adobe Acrobat), as well as expertise in the use of document management and eCTD publishing systems

Knowledge of technologies and processes (e.g., installation, validation) to support document management and electronic publishing a plus

Familiarity with global submissions and/or US or global labeling a plus

Demonstrated leadership skills in the management of individuals and as the submissions publishing expert on project teams

Demonstrated organizational and project management skills

Excellent oral and written communication skills

Required Experience:

5 to 8 years’ experience in document management and publishing functions within the pharmaceutical/biotechnology industry

Work Environment: Office environment; extensive computer use; occasional travel

Physical Demands: N/A

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job Location
Lexington, MA, US

Position Type
Full-Time/Regular

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