• Collaborates to define, develop and lead Marketed Products 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 product life cycle management of assigned program
• Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs
• Stays current with regulations / guidances in Growth and Emerging Markets for impact on drug development plans, registration and life-cycle management to maximize the positive outcomes of 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 and life cycle management
• Assures ongoing efforts towards fulfilment of 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 consultants and Business Partners
• Evaluates new business development opportunities for Growth and Emerging Markets and / or participates on due diligence teams
• Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required. Interacts directly with HA, as required.
• Partner 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

• Bachelor\\\'s degree in a scientific discipline; BA accepted based on experience. Advance degree preferred
• Min 4 years of experience in regulatory affairs within the pharmaceutical industry in development and/or post-marketing phases
• Knowledge of regulations and guidances governing drugs and biologics in development and life-cycle management for growth and emerging markets; and US and EU (relevant to role), including interaction with Health Authorities
• Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies
• Experience managing relationships with external vendors and/or contractors is also preferred
• Willingness to travel to various meetings, including overnight trips

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