Director, Regulatory Affairs Strategy (1127537)

Location: Warren, NJ

Salary: $180,000.00 USD Annually - $210,000.00 USD Annually

Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for executing the company’s regulatory strategy across the development and commercial product portfolio. This individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones.

Responsibilities

• Executes the defined regulatory strategy across the product portfolio.
• Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives.
• Represents Regulatory Affairs within project teams and provides regulatory guidance to R&D, Clinical, Quality and Operations teams, as appropriate.
• Provides guidance to teams and peers to solve problems, achieve goals and meet company defined timelines.
• Provides clear communications of regulatory risk(s) associated with development activities.
• Provides regulatory guidance and recommendations in support of company goals.
• Must exercise judgment within defined procedures and policies to determine appropriate regulatory direction and communicate to
• Serves as primary point of contact with FDA project manager for assigned projects.
• With minimal supervision, leads the preparation of responses to Health Authorities (US and Global).
• Liaises and orchestrates meetings with cross functional
• Participates in product team meetings (development and marketed products).
• Ensures product team activities align with defined regulatory strategy
• Reviews technical documents for submission in new INDs, NDAs and provides guidance to the technical development
• Authors and prepares original INDs/NDAs and amendments for submission to Regulatory
• Manages day-to-day regulatory activities for assigned projects.
• Prepares both major and routine submissions to regulatory applications.
  
  

Qualifications

• Minimum of a bachelor’s degree in a science-related discipline; RAC certification is a plus
• Global regulatory experience in ICH regions and Canada is a plus.
• 10 to 15 years of relevant regulatory experience in pharmaceutical pharmaceutical/biotechnology experience, with extensive knowledge of all aspects of the drug development
• Must demonstrate recognized leadership qualities in previous roles.
• Strong project management skills is a plus.
• Strong knowledge of current US and global regulations/guidelines
• Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands from a variety of R&D, Clinical, QA, Marketing, and Operations team
• Proven ability to communicate with executive management and external thought leaders.
• Demonstrated identification of key regulatory risks.
• Must be well organized, detail-oriented, and can multi-task and manage changing priority
  
  

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Contact: arawat@judge.com

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