Associate, Regulatory Affairs Submission Management (Hybrid)

Responsibilities

• Acts as RA Submissions support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables.
• 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
• 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 guidances including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. Facilitates team reviews.
• 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:
• o Supervision required
• o Receives project assignments from manager but has responsibility for managing own projects with oversight
• o Reviews project progress with manager on a regular basis with direction provided by manager
• o May assist with onboarding staff.

Requirements

• Bachelor's Degree
• 2+ years of pharmaceutical or industry related experience
• NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education
• Publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.
• Drug development experience
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• 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.
• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disa

Benefits

Additional Information

The Associate, Regulatory Affairs Submission Management, manages low to medium impact 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 very knowledgeable in their discipline expert and in regulatory affairs submission management.

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