For our client, an international pharmaceutical company, we are looking for a Regulatory Affairs Manager, Market Products Development, Growth and Emerging Markets (GEM). General Information: Start date: ASAPEnd date: 15.08.2025 Workplace: Zurich Department: Global Regulatory Affairs Workload: 100%Remote/Home Office: Possible About the job: As a Regulatory Affairs Manager, you will define, develop, and lead Global Emerging Markets (GEM) strategies to maximize regulatory success, strengthen the product development plan, enable patient access, and achieve appropriate pricing and reimbursement in alignment with program objectives. This includes managing all aspects of submission processes and ensuring timely approval of investigational applications, marketing applications, and life-cycle management activities. Tasks & Responsibilities: Define, develop, and lead Marketed Products GEM (Global Emerging Markets) strategies to achieve program objectives and maximize regulatory success. Manage, plan, and execute all regulatory activities, including investigation applications, marketing applications, variations, post-approval reporting, and life-cycle management for assigned programs. Communicate regulatory strategies, submission plans, timelines, and impact assessments of regulatory trends and changes to key stakeholders. Stay current on regulations and guidelines in Growth and Emerging Markets (GEM) to assess their impact on drug development, registration, and life-cycle management. Provide regulatory expertise on marketed products in GEM, focusing on non-clinical and clinical aspects of registration and post-marketing compliance. Ensure fulfillment of international product approval conditions for late-stage programs and maintain compliance with registration requirements. Build strong relationships with Local Regulatory Leads, Regional and Global Regulatory Teams, cross-functional teams, and external consultants. Lead or support preparation for Health Authority (HA) meetings, represent the company as required, and ensure effective follow-up on outcomes. Collaborate with regional market access and local regulatory colleagues to align market access and reimbursement strategies with regulatory plans. Must-haves: Bachelor’s degree in a scientific discipline; advanced degree preferred. BA accepted based on experience. Considerable experience in the pharmaceutical industry, including 4+ years of direct regulatory affairs experience in development and/or post-marketing phases. Solid regulatory experience, with knowledge of regulations and guidances for drugs and biologics in development and life-cycle management for growth and emerging markets, US, and EU; including interaction with Health Authorities. Preferred experience managing major regulatory filings and contributing to regulatory and/or development strategies. Ability to interpret complex scientific issues across multiple projects related to regulatory requirements and strategy. Strong communication, timeline management, and negotiation skills, with experience in regulatory strategy and risk mitigation. Proven ability to work independently and collaborate effectively within global teams and with senior leadership. Effective manager with experience bringing cross-functional teams together to achieve common objectives. Willingness to travel to various meetings, including overnight trips. If this sounds like the perfect opportunity for you, we’d love to hear from you! Submit your CV today and be part of a leading pharmaceutical company driving healthcare innovation.
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