Regulatory Affairs Manager (US Market)

Randstad Switzerland; Ticino; On-site; CHF 150,000 - 230,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

US regulatory strategy

Regulatory submissions

Regulatory due diligence

Life cycle management

Regulatory intelligence

Education

Bachelor's degree in a scientific discipline

Master's/PhD preferred

Job description

Our client is a well-established, global pharmaceutical company with over a century of history, specializing in high-quality therapies across key areas such as anesthesia, analgesia, and acute care. Headquartered in Southern Switzerland, the company focuses on continuous innovation to improve drug formulation, safety, and patient outcomes worldwide.

To support their international expansion, we are seeking an experienced Regulatory Affairs Manager dedicated to leading strategy and compliance for the US Market.

Position Summary

Reporting directly to Corporate Functions, the Regulatory Affairs Manager (US Market) will be responsible for the strategic development, planning, and operational execution of Regulatory Affairs priorities for both new development programs and in-line products in the United States, in full compliance with US FDA regulations.

Key Responsibilities

• US Regulatory Strategy & Submissions: Define and execute regulatory strategies for the US market. Provide strategic oversight and hands-on support for NDAs (with a primary focus on 505(b)(2)), ANDAs, INDs, iPSPs, and formal meeting interactions with the US FDA.
• Development Programs & Due Diligence: Oversee early- and late-stage development initiatives, conducting regulatory due diligence for licensing-in opportunities, including critical assessments of regulatory pathways, risks, timelines, and probability of technical/regulatory success.
• Life Cycle Management & In-Line Support: Partner with the Area Project Manager to manage post-approval submissions, annual reports, PADERs, and regulatory reviews for advertising/promotional materials.
• CMC & Labeling Changes: Provide strategic direction and guidance for implementing CMC and labeling changes affecting US registrations (including classification and execution of CBE, CBE-30, and PAS filings under current FDA guidelines).
• Maintenance & Compliance: Maintain post-approval change submission plans in coordination with project management to ensure timely execution and compliance.
• Regulatory Intelligence: Stay up-to-date with evolving US pharmaceutical legislation, guidelines, and FDA policies, serving as an internal subject matter expert to mentor and foster growth within the broader RA team.

Qualifications and Skills Required

• Education: Bachelor’s degree in a scientific discipline (Pharmacy, Pharmaceutical Chemistry, Biology, or related field); an advanced degree (Master's, PharmD, or Ph.D.) is preferred.
• Experience: Minimum of 10 years of progressive experience in Regulatory Affairs, with a strong, hands-on background in US-focused projects (NDA, ANDA, 505(b)(2), IND, iPSP, and formal FDA meetings).
• US Regulatory Expertise: In-depth knowledge of US FDA regulatory requirements governing both drug development and full post-approval life cycle management for generic and new pharmaceuticals.
• Languages: Full professional proficiency in written and spoken English is required.

Soft Skills & Management:

• Proven ability to work autonomously, prioritize tasks, and manage complex projects with minimal supervision.
• Team player with excellent communication skills: Proven ability to collaborate effectively with cross-functional and multi-site teams
• Exceptional organizational skills and keen attention to detail.
• Demonstrated track record of coordinating multiple cross-functional initiatives in an international environment.