Job Postings

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  The Regulatory Affairs Specialist applies their knowledge to the delivery of regulatory and quality solutions to enable client success. The Regulatory Affairs Specialist delivers quality services and executes the defined consulting scope of work with minimal oversight by experienced consultants. This role has the day to day responsibility for leading client projects to support product development, submissions, and post marketing activities

  The Regulatory Affairs Specialist applies their knowledge to the delivery of regulatory and quality solutions to enable client success. The Regulatory Affairs Specialist delivers quality service and executes the defined consulting scope of work with minimal oversight by experienced consultants. This role has the day to day responsibility for leading client projects to support product development, submissions, and post marketing activities.

Cato Research LLC

  The Sr. Regulatory Submissions specialist performs the preparation, compilation and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices. Increasing level of responsibility, knowledge and experience of types of submissions and regulatory regions. The Sr. Publisher is a team leader within the Regulatory Operations department.

  Dova is currently seeking a seasoned pharmaceutical industry professional to join our Regulatory team as an Associate Director of Regulatory Affairs while based at our office in Durham, NC. This person will report to our Vice President of Regulatory Affairs and will be responsible for contributing to the development and implementation of global regulatory strategy for assigned projects. This individual will provide regulatory oversight for regulatory activities across the product lifecycle, from development through post-approval. This person will be expected to independently manage projects, functioning as the accountable regulatory lead. This person may interact directly with FDA and other regulatory agencies. To be successful in this role, you must be able to provide sound regulatory guidance, communicate clearly (in verbal and written form), operate effectively within teams, and display exemplary organizational / project management skills.

JobID: ADRA

 The Regulatory Affairs Associate supports the Regulatory Affairs team in preparation and maintenance of documentation for use in regulatory registrations and submissions. The Regulatory Affairs Associate works closely with all members of the Regulatory Affairs team and with other internal groups to ensure compliance of submissions and programs with US, EU, and ICH requirements.

 The CMC Regulatory Lead will be a key member of the Regulatory Affairs team and interface with various Cell and Gene Therapy groups in the company to provide leadership and guidance for a wide range of topics related to CMC regulatory affairs for our cell and gene therapy development programs. The CMC Regulatory Lead will work closely with all members of the Regulatory Affairs team and with individuals involved in CMC Development, CMC Technical Operations, Quality Assurance, and Quality Control at Precision BioSciences to ensure compliance with US, EU, and ICH requirements.

  Join a growing team at a gene therapy start-up focusing on developing innovative products for oncology. The role is focused on regulatory operations and regulatory writing while contributing to overall program strategy for the company.

 We are currently recruiting for a Regulatory Submissions Specialist to join our team in the San Diego, CA or Cary, NC location.   The Regulatory Submissions Specialist performs the preparation, compilation and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices.