Regulatory Affairs Specialist
Edison-New Brunswick Metro Area, NJ
Under the direction of their supervisor, this individual will be responsible for managing BLA applications and providing US regulatory support for marketed vaccine products, contributing US Regulatory strategies as a member of applicable Global Regulatory Teams.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
Contributes to the development and oversees the successful implementation of regulatory strategies for assigned products, including submission and maintenance activities related to BLA applications.
Leads and/or participates on multi-disciplinary matrixed project teams that work to project deadlines while adhering to regulatory requirements for products and/or projects.
Consults with management to develop and communicate robust product-specific regulatory strategies to mitigate risk; works in conjunction with brand team management and global regulatory lead to provide advice and risk/benefit analysis to maximize value to stakeholders.
Serves as primary contact with FDA, manages FDA relationships ensuring communications are documented; establishes and maintains strong collaborative relationships with Legal, Medical, Marketing, Supply Chain, and Compliance.
Manages and participates in the development, monitoring and updating of standards and processes related to biologics regulations.
Knowledge and understanding of complex medical and scientific subject matter.
Ability to work well within cross-functional teams.
Can demonstrate solid oral communication and writing skills.
Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.
Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
Develops collaborative relationships to facilitate the accomplishment of work goals.
In conjunction with their supervisor, generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.
Can build networks to obtain cooperation.
Unquestionable ethics, professional integrity and personal values consistent with the company values.
Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well.
Deals with people in an honest and forthright manner representing information and data accurately.
Bachelor s degree from an accredited four-year college or university
Area of specialization: Life Sciences