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Manager of Regulatory Submissions

Company: Atlas Search
Location: Dayton
Posted on: January 16, 2022

Job Description:

We are currently partnered with a growing biotech that is seeking a Quality Assurance Documentation Specialist to join their team. This role is responsible for providing administrative and study operational support to the clinical study teams. This is a great opportunity to join a team that is currently working on advancement of difficult to treat and often life threatening infections by developing innovative therapies

Responsibilities:

Lead and manage the submission dossier project management / coordination and work with team members to identify critical path of submission
Maintain the regulatory affairs submission calendar, and reports on key submission milestones to stakeholders, as applicable.
Assist with hands-on daily submission compilation and publishing activities associated with preparation of various dossier types.
Identify resources and provide guidance for process updates to due changing regulations that impact submission strategies and technologies, SEND, CDISC, Validator Software, etc. This includes but is not limited to identifying the validation checks needed to ensure compliance with eCTD Specifications for world-wide regulatory agencies.
Identify risks and opportunities and address as needed, focusing on customer satisfaction requirements by supporting best practices, Working Procedures and SOPs.

Requirements:

Minimum of a BA/BS
5+ years of regulatory experience within industry

Keywords: Atlas Search, Trenton , Manager of Regulatory Submissions, Executive , Dayton, New Jersey

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