Manager Regulatory Affairs (m/f/d)

Responsibilities 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. 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. Manages, trains, provides direction, strategic guidance and solutions to projects, mentors team members, to support 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. Qualifications Bachelor’s degree in a scientific discipline; BA accepted based on experience, advance degree preferred. Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and/or post-marketing phase. 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 (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. Generally strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Experience managing relationships with external vendors and/or contractors is also preferred. Additional Information International environment. Career growth opportunities. #J-18808-Ljbffr