Job Description

About AbbVie
AbbVies 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 peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens 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.

Abbvie has an exciting opportunity in Regulatory Information Management for a Senior Manager to join our International Regulatory Affairs team to provide assigned European leadership, oversight, data governance and ensure execution of strategy/objectives for the growing and evolving RIM function.

You will lead assigned European projects and take an ownership role in design, roll-out and maintenance of Regulatory Information Management systems and processes through collaboration with stakeholders from the assigned country/regional Regulatory Affairs, R&D;, as well as R&D; IT organizations.

You will also support the administration of an authoritative source for regulatory information ensuring the appropriate elements are captured and maintained. Increase the utilization of Regulatory information through stakeholder engagement using advanced reporting and analytics of RIM data.

KEY DUTIES AND RESPONSIBILITIES

* Responsible for assigned leadership of European RIM organization. Responsible for overseeing activities related to RIM resources, budget, management of assigned activities, analysis of submission and registration information, and metrics reporting.
* Support regulatory information management activities within the Europe region, focusing on key systems and processes, including the RIM system (BRIDGE), the Artwork Management System (The Hub) and XEVMPD/IDMP. Additionally, engages in the execution of International RIM obligations, when necessary.
* Oversee the eArchiving process for the European RIM team which may also involve the eArchiving for other international regions.
* Responsible for maintenance and development of European SOPs, Work Instructions, etc. related to Regulatory Information Management. Identify and initiate on-going continuous process improvement opportunities with stakeholders responsible for RIM data consumption. Educate stakeholders regarding the process and data requirements needed to successfully maintain and capitalize on a RIM system.
* Define, monitor, interpret and convey key performance indicators/metrics for critical Regulatory Affairs processes and output for the European region. Support the initiation and deployment of forecasting, budgeting and maintenance of ex-US health authority fees using reporting systems to ensure compliance with International requirements.
* Lead support of assigned European Regulatory RIM objectives, ensuring accurate, complete and timely capture and submission of regulatory information in support of regulatory planning, tracking and reporting needs.
* Build and maintain relationships with Regulatory and other staff within and outside of the region to ensure effective communication and efficient implementation of regulatory information management standards and processes
* Monitor emerging health authority regulations and programs impacting RIM and other designated RA systems. Interact with industry groups to identify regulatory trends and policy that could impact current systems and processes and develop strategies to ensure compliance with new requirements.
* Support the initiation and deployment of forecasting, collection and maintenance of ex-US health authority fees using reporting systems to ensure compliance with International requirements.
* Implement, maintain and interpret Key performance indicators/metrics for critical European Regulatory Affairs processes and regional output. Lead local initiatives to integrate Regulatory information and records for acquired assets, products or organizations.

Qualifications
Education and Experience

* Graduate (preferably in a Life Science or IT related discipline), or equivalent/relevant experience.
* Experience of Regulatory Information Management systems.
* Understanding of emerging regulations such as XEVMPD, IDMP and UDI
* Knowledge and understanding of regional regulations and guidance and ICH guidelines pertaining to Regulatory Affairs and / or Regulatory Operations including IND, NDA, MAA, CTA etc.
* Familiarity with European Procedures (Centralised, Decentralised and Mutual Recognition)
* Some knowledge and experience of all submission types (MAAs, Variations, Renewals, CTAs, DSURs etc)

Essential Skills and Abilities

* Excellent verbal and written communication skills
* Ability to interpret and summarize information from multiple sources including regulations, health authority guidances, and internal documents
* Ability to multitask and prioritize under moderate workload with some supervision
* Computer literate with proficiency in MS Office applications and MS Project
* Proficiency in document management systems and/or ability to quickly learn new systems and technologies
* Exercise independent judgment
* Sense of personal responsibility and accountability
* Understanding of drug development processes
* Ability to manage and mentor junior team members
* Ability to supervise external consultants

Travel
Yes, 25 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.