Regulatory Affairs Associate

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

As an individual contributor, the Regulatory Affairs Associate, Global Submission Support, will combine regulatory, business, and scientific knowledge to provide support with regulatory submissions, agency responses and internal queries for AbbVie global product portfolio. Duties include managing end-to-end process for obtaining legalized documents and regulatory samples required by health authorities, maintaining data in various systems and tools, working with cross-functional partners and project teams, and communicating with external organizations, companies, and vendors. This individual is recognized as very knowledgeable in their discipline and in regulatory affairs submission support for emerging markets. 

• Serves as primary point of contact with Affiliate Regulatory team for country/region specific document and sample requests to support local regulatory submission activities for new product registrations or to maintain existing product registrations. 
• Assembles information, submits applications, and serves as point of contact for Health Authorities and other government agencies, embassies and consulates to obtain and complete affiliate document requests. Documents may include Certificates of Pharmaceutical Products (CPPs), Certificates of Foreign Government (CFGs) and others. 
• Collaborates with internal teams across AbbVie sites and with Third-Party Manufacturers (TPMs) to obtain documents such as GMP Certificates and Manufacturing Licenses. 
• Communicates and coordinates with external vendors to ensure legalization of documents in accordance with specific country requirements. 
• Manages end-to-end processes of procuring regulatory samples in compliance with established procedures, pa