US Regulatory Affairs Lead: NDA/ANDA Strategy & Compliance

Randstad Switzerland; Ticino; Sur place; CHF 150 000 - 230 000; Plein temps

Résumé du poste

Randstad Switzerland is recruiting an experienced Regulatory Affairs Manager (US Market) for a global pharmaceutical company headquartered in Southern Switzerland. The role oversees regulatory strategy, submissions, and lifecycle management for the US market, ensuring FDA compliance and strong cross-functional collaboration.

Responsibilities include NDA/ANDA/505(b)(2) submissions, FDA interactions, and ongoing regulatory intelligence to support development and in-line products.

Qualifications

• Bachelor’s degree in a scientific field is required.
• Advanced degree (Masters, PharmD or PhD) is preferred.
• Strong English communication and leadership capabilities.

Responsabilités

• Define and execute regulatory strategies for the US market for NDA/ANDA/505(b)(2).
• Lead regulatory submissions and interactions with the US FDA (INDs, iPSPs, meetings).
• Oversee development programs, due diligence, and licensing assessments.
• Manage lifecycle activities: post-approval changes, annual reports, and labeling.
• Provide regulatory intelligence and mentor RA team members.

Connaissances

US regulatory strategy

Regulatory submissions

Regulatory due diligence

Life cycle management

Regulatory intelligence

Formation

Bachelor's degree in a scientific discipline

Master's/PhD preferred

Description du poste

Randstad Switzerland is recruiting an experienced Regulatory Affairs Manager (US Market) for a global pharmaceutical company headquartered in Southern Switzerland. The role oversees regulatory strategy, submissions, and lifecycle management for the US market, ensuring FDA compliance and strong cross-functional collaboration.

Responsibilities include NDA/ANDA/505(b)(2) submissions, FDA interactions, and ongoing regulatory intelligence to support development and in-line products.