We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations. For assigned projects, the Senior Manager of Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing, distribution, and archiving of health authority submissions.  The Senior Manager will oversee the activities of external publishing staff contracted to publish and dispatch health authority submissions.

Job Duties and Responsibilities

• Overseeing the external Submission Managers with defining submission outlines, content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed.
• Manages the external submission Managers to ensure the accurate and timely management of the tracking, compiling, publishing, quality checking, dispatching and archiving of Health Authority submissions.  As needed, prepares and dispatches OPDP submissions. Oversees the activities of external publishing staff contracted to publish and dispatch health authority submissions.
• Facilitates submission preparation via completion of forms and creation of cover letters.
• Represents Regulatory Operations on project teams for matters relating to electronic (and paper) submissions.
• Overseeing the external Submission Managers to ensure accurate Printing, distributing, and archiving all incoming and outgoing communications with FDA and international counterpart agencies.
• Leads in the implementation, validation, and operation of eCTD and electronic document management systems and other publishing and submissions technology projects.
• Leads the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities. As needed, trains colleagues and project teams.
• Understands evolving Health Authority (HA) standards and procedures for regulatory submissions. Guides and trains project teams on new requirements, along with proposals for implementation.
• Coordinating and consulting with other departments on the content, review, and assembly of regulatory documentation.  Ensure consistency, completeness, and adherence to standards for all regulatory submissions.
• Assisting in the creation of regulatory project plans and timelines for multiple projects or developmental programs. Maintaining project timelines and providing updates to senior management.
• Leads the training of appropriate R&D staff in the application of various standards and technologies including templates, document management practices, eCTD publishing, and other tools used within the group.

Key Core Competencies

• Requires a detail-oriented self-starter with excellent organizational, planning, and follow-up skills, as well as communication, teamwork, and interpersonal skills.
• Ability to meet tight competing deadlines, juggle multiple priorities and multi-task.
• Extensive knowledge of regulatory submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software.
• Thorough understanding of FDA and other health agency regulations and guidance’s governing submission content and format.

Education and Experience

• High School (Bachelor’s degree preferred)
• Minimum 8 years (w/o Master’s) or 6 – 8 years (with Master’s) years of relevant experience in biotech or pharmaceutical industry
• 7+ years’ experience in a fast-paced, high-volume document production environment (e.g., documentation, publications, electronic publishing) or clinical environment, preferably in the biotechnology/ pharmaceutical industry or another health care industry.

The base salary range for this role is $126,600 to $155,000.  Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.