Manager, Regulatory Affairs Submission Management

Purpose:

The Manager, Regulatory Affairs Submission Management, manages high impact, complex submission projects involving multiple cross-functional regulatory submission teams. 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 discipline expert and resource in regulatory affairs submission management.

Responsibilities:

• Independently manages high 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 primary RA Submissions interface with project teams providing guidance and communication of established submission processes, standards and technical specifications. Plans and negotiates submission project scope, publishing timelines and deliverables.
• Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.
• Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks
• May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support. Facilitates the creation or procurement of submission content deliverables such as cover letters and forms   Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
• Facilitates team reviews and ensures detailed quality reviews of published output are completed per current standards to ensure compliance with Regulatory Standards and Health Authority guidance including verification of content, bookmarks, hypertext links and tables of content in complex submissions.
• Actively 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. Creates, implements, and finalizes internal process and standards documents relating to publishing and publishing deliverables.
• Suggests and implements process improvements. May recommend changes to software and business processes to support changes in regulations that support complex submissions. May lead or participate on internal project teams to update business software.
• Position accountability/scope:
  • Minimal supervision required
  • Receives project assignments from manager but has responsibility for managing own projects
  • Reviews project progress with manager on a regular basis with direction provided on follow-up
  • Provides estimates of activities with budgetary impact.
  • Trains, mentors and may supervise the work of less experienced staff

Qualifications:

• Required Education: Bachelor’s degree  Note: Years of experience may also compensate for lower education.
• Preferred Education: PMP and RAC certificates a plus
• Required Experience: Six years pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.
• 1-2 years in cross functional project management
• NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.

 

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our short-term incentive programs. 

  This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.