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Organisation:
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Senior Associate/Specialist, Regulatory Affairs Submission Management, manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams.
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 medium to 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 Submission Operations interface with project teams providing guidance and communication of established submission processes and standards. Provides input to project scope, especially as it impacts 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 moderately 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 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 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 creation, and 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 team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
- Position accountability/scope:
- Some supervision required
- Receives project assignments from manager but has responsibility for managing own projects with some oversight
- Reviews project progress with manager on a regular basis with direction provided by manager
- Trains, and mentors less experienced staff.
Qualifications
- Bachelor’s Scientific degree
- Note: 3-5 Years of experience.
- 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.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email [email protected].
