US Regulatory Affairs Lead – NDA/ANDA Strategy & Compliance

Randstad Switzerland; Ticino; On-site; CHF 180,000 - 240,000; Full time

Job summary

Randstad Switzerland is recruiting a Regulatory Affairs Manager (US Market) for a global pharmaceutical client. You will shape regulatory strategy, lead US submissions, and ensure compliance across development programs and post‑approval activities.

The role requires a strong background in NDA/ANDA/505(b)(2), INDs, and FDA interactions, with at least 10 years in Regulatory Affairs and fluent English. Based in Southern Switzerland with responsibilities spanning the US regulatory landscape.

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Chemistry, Biology, or related field.
• An advanced degree (Master's, PharmD, or Ph.D.) preferred.
• 10+ years of Regulatory Affairs experience with US-focused projects (NDA, ANDA, 505(b)(2), IND, iPSP, and formal FDA meetings).
• Fluent English, written and spoken.

Responsibilities

• Define and execute regulatory strategies for the US market and lead NDA/ANDA/IND submissions.
• Oversee regulatory due diligence for licensing opportunities with risk, timelines, and probability of technical/regulatory success.
• Manage post-approval lifecycle activities including annual reports and PADERs.
• Provide strategic guidance on CMC and labeling changes per FDA guidelines.
• Maintain submission plans and ensure regulatory compliance across programs.
• Stay up-to-date with US FDA regulations and mentor the RA team.

Skills

Regulatory strategy

US regulatory submissions

FDA interactions

Lifecycle management

Cross-functional collaboration

English proficiency

Education

Bachelor’s degree in a scientific discipline

Advanced degree (Master's, PharmD, or Ph.D.) preferred

Job description

Randstad Switzerland is recruiting a Regulatory Affairs Manager (US Market) for a global pharmaceutical client. You will shape regulatory strategy, lead US submissions, and ensure compliance across development programs and post‑approval activities.

The role requires a strong background in NDA/ANDA/505(b)(2), INDs, and FDA interactions, with at least 10 years in Regulatory Affairs and fluent English. Based in Southern Switzerland with responsibilities spanning the US regulatory landscape.