Regulatory Affairs Submission Management Associate (Contractor)

About This Role

Objectives

With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as a very knowledgeable in their discipline expert and in regulatory affairs submission management.

Key Responsibilities

• Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
• Acts as Submission Management support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables.
• Participates in submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines. Anticipates obstacles and proposes solutions within the team.
• Coordinates submission publishing with offsite publishers/provides notification to ensure resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues.
• Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.
• Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance’s including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. Facilitates team reviews.
• Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables.
• Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
• Demonstrates ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
• Position accountability/scope:
• Supervision required.
• Receives project assignments from manager but has responsibility for managing own projects with oversight.
• Reviews project progress with manager on a regular basis with direction provided by manager
• May assist with onboarding staff.

Qualifications

Bachelor’s degree.

Note: Years of experience may also compensate for lower education.

PMP and RAC certificates desirable.

Competencies

• Pharmaceutical or industry related experience.
• Experience working in a complex and matrix environment.
• Strong communication skills both oral and written.
• Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area.
• Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
• Proven leadership skills and presence.