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Regulatory Affairs Manager (M/F/D)
Tasks:
Defines, develops and leads GEM strategies to maximize regulatory success towards achievement of program objectives
Independently manages, plans and executes all aspects for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general prduct lifecycle management of assigned program
Stays current with regulations / guidances in Growth and Emerging Markets for impact on drug development plans, registration and life-cycle management to maximize positive outcome on the regulatory applications and maintain registration compliance
Provides regulatory expertise on Marketed Products in GEM for multiple projects, focused on non-clinical and clinical aspects of registration and / or post-marketing compliance
Assures ongoing efforts towards fulfillment on international product approval conditions for late stage programs
Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional teams, company´s consultant and Business Partners
Evaluates new business development opportunities for Growth and Emerging Markets and / or participates on die diligence teams
Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required
Represents GEM RA in Health Authority meetings
Effectively communicates and manages meeting outcome and next steps, as required
Manages, trains, provides direction, strategic guidance and solutions to projects, mentors team members, to suppot scope of project work
Partners with the regional/Loc market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans
Responsible for demonstrating leadership behaviour
Qualification:
Bachelor´s degree in a scientific discipline; BA accepted based on experience
Considerable experience within the pharmaceutical industry and including direct experience in regualtory affairs in development and / or post-marketing phases
4 years of directly related regulatory experience is desirable
Solid regulatory experience, including knowledge of regulations and guidances governing drugs and biologics in development and life-cycle management for growth and emerging markets; and US and EU, including interaction with Health Authorities
Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies
Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
Generally strong and independent skills in regulatory strategy such as understanding broad concepts within regultory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership
Effective manager who is able to bring working teams together for common objectives
Experience managing relationships with external vendors and/or contractors is also preferred
Requirements:
Start: 19.02.2025
Duration: 6 months
Capacity: 5 days per week
Location: Zurich Metropolitan Area
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