Regulatory Affairs Manager

Aptar is a leader in the development and manufacture of dosing, delivery, closure, and protection systems for the pharmaceutical and consumer industries. With 3 Business Segments, Pharma, Beauty and Closures, Aptar has a turnover of $3.5 billion worldwide.

Within the Pharma segment, the 3 divisions (RX/Prescription, Injectable, CHC) develop and produce plastic components with nearly $1.5 billion in turnover is present in the Channel with several production sites and also operates abroad (EU, Asia).

THE APPOINTMENT

The Manager Regulatory Affairs, Pharma US will manage and execute the US regulatory affairs for Aptar Pharma across the 3 divisions (mainly RX in short term) to strengthen Aptar Pharma leadership in drug delivery systems and clearly position Aptar Pharma as a solution provider.

Key Responsibilities

• Define the regulatory strategies for US market activities (routine, R&D, product development).
• Ensure the relationship/meetings with FDA
• Ensure that the documentation produced by Aptar Pharma for regulators and customers is in full compliance with current global regulation related to Drug Delivery Systems /Devices (e.g. DMF, customer files, Combination Product documents, medical devices, materials compliance etc)
• Further develop and maintain the relationship with FDA regulatory body
• Closely work with the divisions RA Managers and their teams
• Closely monitor regulatory trends and anticipate changes at US level with potential to impact Aptar Pharma: continue develop Regulatory Intelligence Management system (RIM)
• Establish & maintain a suitable network of Subject Matter Experts (SMEs)
• Ensure the update of the regulatory database
• Ensure that regulatory requirements are appropriately considered and taken into account in product development
• Manage local regulatory resources if needed  
• Attend relevant regulatory conferences

THE CANDIDATE

Desired Skills and Experience

• Post graduate degree in Regulatory Science, Pharmaceutics or Chemistry
• Experience in Regulatory affairs in Pharma ideally in RX, INJ, CHC and relationships with manufacturing sites (8-12 years)
• Knowledge of regulatory affairs Plasturgy and Pharma regulations
• Good leadership skills
• Easily build relationships and rapport
• Strategic and operational capabilities
• Ability to exchange with FDA regulatory authority
• Experience of management is a plus
• French language is a plus

Office locations for the role

• Congers Site/Aptar – USA  
• Remote work is possible (US Eastern Coast is required)