Job Abstract

The Associate Director of Regulatory Innovation supports regulatory objectives for Allergan Aesthetics products including coordination, management of global submissions. Directs and supports development of the regulatory strategy with a focus on Clinical Outcome Assessment (COA) tools including digital and submission activities for device regulatory approvals in a variety of counties including EU, US, Japan, and China. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support Allergan Aesthetics at Regulatory Authority/Notified Body meetings as well as industry meetings. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations and regulatory guidance as well as all company policies and procedures.  

Responsibilities include:  

• Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through life cycle management of the medical product.


• Authors and s upports regulatory submissions, regulatory operations, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of Declaration of Conformity as applicable. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues.


• Provides regulatory policy, intelligence interpretation and strategy (e.g., Pharma and Medical Device Regulation) for medical products to support global regulatory plans.


• Coordinates across the Allergan Aesthetics portfolio with the regulatory teams of each portfolio to provide consistent strategies for broad regulatory issues such as digital health t echnology and clinical outcome assessments


• Acts as a key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements. Participates in and contributes to industry and professional meetings to maintain competency on regulatory policy issues.?


• Provides leadership, remains accessible and coaches employees when needed; maintains high levels of work and employee accountability.


• Supports and develops global regulatory teams to meet company objectives .  



 
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