Regulatory Affairs Project Manager H/F Real Staffing

The Project Manager will interact with and influence internal RA and external stakeholders. The PM will make launch data commitments to businesses and manage stakeholder expectations with regard to program deliverables during the program. The program in scope is related to labelling changes (Legal Entities and branding). This person will serve as a champion of product lifecycle management processes, recognizing how program results impact the overall success of the organization. The PM will also develop core team and project management capabilities across the organization.



Essential Duties and Responsibilities:

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Accountable for core team performance, program schedule and execution.
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Leads team in defining program strategies, developing goals, and orchestrating team appraisal process.
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Provides clear direction on product lifecycle management requirements to meet expectations of external customers and business stakeholders.
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Interacts through program updates and reviews with all functions and levels of management, ensuring effective ongoing communications across teams and stakeholders.
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Ensures identification and communication of program/project risks, development of risk plan and proactive management of risk response strategies.
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Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes.
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Maximizes business results through continuous improvement in the organization's ability to execute programs from identification through implementation.



Knowledge, skills, and/or abilities required:

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Strong business acumen.
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Role model of Vital Behaviors and Leadership Essentials.
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Expertise in all aspects of program management.
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Experience working in a drug-regulated environment.
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Familiarity with Marketing Authorization transfer and labelling changes.
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Project management certification preferred.



Education and/or Experience:

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MBA/MS or Bachelor's degree (or equivalent).
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5+ years of project management experience.
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Demonstrated success leading multi-site, global or enterprise-wide programs in the pharmaceutical or medical device industry.