Regulatory Manager

Execruit; Milwaukee (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

Execruit in Milwaukee, Wisconsin is seeking a regulatory affairs professional with expertise in compliance and project management. The role requires a Master's degree in life sciences or pharmacy and experience in key regulatory functions. Candidates should have successfully managed product launches in Switzerland and possess strong communication skills, especially in English and German. The position involves guiding regulatory submissions and managing relationships with health authorities in Switzerland and the EU.

Qualifications

• Experience in a key regulatory function in the Swiss affiliate of a pharmaceutical company.
• Knowledge of international regulatory requirements.
• Experience with launches of generics and/or NCEs in regulatory affairs.

Responsibilities

• Provide strategic guidance on regulatory requirements and submissions.
• Actively manage relationships with regulatory agencies.
• Manage Swiss National dossier filings and contribute to centralized dossier preparation.

Skills

Regulatory compliance expertise

Project management

Client communication

Fluent in English and German

Education

Master degree in life sciences or pharmacy

Job description

Key Responsibilities

• Provide strategic guidance on regulatory requirements and submissions, first in Switzerland, but later also in the EU
• Actively manage relationships with Swissmedic, EMEA and potentially other regulatory agencies
• Navigate the Swiss Regulatory Ecosystem, including being connected to professional working groups
• Diretcly manage Swiss National dossier filings & other EU filings and contribute to centralized dossier preparation
• Offer expert advice on new product applications and lifecycle maintenance
• Lead small-scale projects or work streams, ensuring client satisfaction and project success
• Collaborate with cross-functional teams to deliver high-quality regulatory solutions with ambitious timing requirements

Your Profile

• Master degree in life sciences, pharmacy studies or related areas.
• Must have worked in a key regulatory function in the Swiss affiliate of a pharmaceutical company for several years, having had a QP/RP responsibility to Swissmedic is an advantage.
• Has successfully managed at least 1-2 launches of generics and/or NCEs in regulatory affairs in Swiss Market, practical launch experience through EMEA centralised procedure is a strong advantage
• Existing network to Swissmedic, BfArM, and other EU national Health Authorities is a strong advantage
• In-depth knowledge of international regulatory requirements
• Strong understanding of EU regulatory landscape
• Excellent project management and client communication skills
• Ability to work independently and as part of a team
• Proactive problem-solver with keen attention to detail
• Fluent English and German speaker (required)