Senior Specialist, Regulatory Affairs Submission Management

企業概要

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

求人内容

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 Management 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.

資格

Trains, and mentors less experienced 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

その他の情報

GradeはG16を予定していますが、経験値によりG14でのオファーとなる場合があります。

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。