Associate Director/Director - Regulatory

Regulatory Lexington, Massachusetts


Description

 

Associate Director/Director, Regulatory

Please place Kaleido ID# Here 

Kaleido Biosciences is a clinical-stage healthcare company with a differentiated, chemistry-driven approach to leveraging the potential of the microbiome organ to treat disease and improve human health. The Company’s Microbiome Metabolic Therapies (MMT™) are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the organ’s existing microbes. Kaleido is advancing a broad pipeline of MMT candidates to address a variety of diseases and conditions with significant unmet patient needs. The Company’s human-centric discovery and development offers the potential to be faster and more cost-efficient than traditional drug development. We also have an exceptional team that is committed to scientific innovation, transforming lives and building a strong culture.

 

Overview:

        Kaleido is seeking a highly motivated Regulatory Affairs Manager/Associate Director with broad responsibility across multiple products in development. He/She will evaluate regulatory requirements, and author, and facilitate compilation of information necessary for global regulatory submissions to ensure timely and accurate filings to secure approvals of clinical trial applications.  The ideal candidate will provide strategic regulatory guidance to cross functional teams as well as serve as the regulatory representative providing general support to clinical development teams on specific programs. This is a newly created role is intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in preclinical and clinical stages of novel drug development.  You will have the opportunity to broaden your regulatory expertise and work with dedicated, driven colleagues at a growing company to develop therapies that target the microbiome to treat disease and improve human health. 

 

 

 

Summary of Key Responsibilities:

  • Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs including liaising with vendors and CROs as needed.
  • Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
  • Contribute to the development and implementation of regulatory strategy.
  • Lead initiatives for project and timeline management in support of regulatory objectives and projects.
  • Works with project teams regarding the development and execution of regulatory strategy through the clinical development processes, with guidance from the Regulatory Sr. Director.
  • Author high-quality regulatory submission content to support global clinical development, registration, and product life cycle management (INDs, IMPDs, DMFs, ANDAs, NDA/BLA, QOS, etc.)
  • Manage regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments on deviations, CAPAs, change controls, etc.
  • Regulatory agency meeting support including meeting preparation and briefing document creation.
  • Review external communications materials for compliance
  • Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).
  • Actively participate/lead regulatory CMC infrastructure and capability building, including developing best practices, training tools, and cross-program learning.

 

 

Qualifications:

  • BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.
  • 8-10 years of experience in Regulatory supporting pre-IND/scientific advice briefing book generation, IND submissions and ex-US clinical trial application submissions (NDA experience a plus)
  • Experience with developing strategy, contributing to and managing regulatory submissions including CMC-specific submissions
  • Ability to work both independently and within project teams, committees, etc. to achieve group goals.
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance--preferably from at least both US and EU
  • Ability to adapt under regularly changing conditions
  • Ability to translate strategic goals of partnerships/customers or internal projects into tactical goals
  • Experience with providing regulatory assessments on change controls, deviations, corrective action plans

 

 

 

Kaleido Biosciences is an EEO employer committed to an exciting, diverse, and enriching work environment.