Wilmington, DE - Regulatory Submission Associate

JOB DESCRIPTION:

• Compile and publish assigned regulatory submissions
• Coordinate printing and distribution of those submissions to all concerned markets within agreed timeframes
• Manage the associated submission and product life-cycle regulatory status information

RESPONSIBILITIES:

• Effectively communicate submission format requirements to the submission team
• Collect necessary information and requirements from the submission team
• Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools
• Manage assigned regulatory status information for assigned markets
• Ensure printing and distribution of regulatory submissions, paper and electronic, to all concerned markets, as required
• Analyze submissions, track and record life-cycle information in accordance with standards
• Perform searches on submission life-cycle information, as required
• Take responsibility for and ensure regulatory submissions meet all mandatory health authority validation requirements
• Participate on project teams (e.g., skill work, standards, or harmonization)
• Participate on SMG working teams
• Seek advice in and share best practices within SMG
• The Job Holder has a responsibility to comply with, or be aware of (as appropriate) all relevant policies and cross-functional procedures

INTERNAL AND EXTERNAL CONTACTS/ CUSTOMERS: 

• Global Regulatory Leads (GRLs)
• Other R&D functions (Clinical, Safety Assessment)
• Operations (CMC post approval)
• Marketing Companies
• Health Authorities

REQUIREMENTS:

• University degree or relevant equivalent experience
•  Basic knowledge of information management and document management
• Technical orientation, attention to detail
• Good written and verbal communication skills

PREFERED BACKGROUND:

• Basic knowledge of the drug development process, product life-cycle, and contents/formatting of regulatory submissions
• General understanding of other functions
• Knowledge of submission compilation, publishing, approval information processes, tools and standards

SUBMIT RESUME to Resume@ABOUT-Consulting.com

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