Job Postings

Date Posted

Company

Position

  RTI International is currently seeking a Regulatory Affairs Scientist with a background and interest in clinical regulatory activities as it relates to biopharmaceutical development. The primary responsibility of this position will be to provide regulatory guidance, supplemental writing, and review of clinical reports and pertinent regulatory submission sections for drugs, biologics, or diagnostics development projects. This individual will fulfill a key role with a focus on clinical affairs as a member of a team of scientists in RTI’s Global Health Technologies group working to develop new products to address critical unmet global health needs and opportunities.

JobID: 200UE

  This is an opportunity for an individual to serve as an integral member of development teams and play an instrumental role in the strategic planning and execution of critical development primarily for Early Development programs for Drugs, Biologics and/or Medical Devices. This cross-functional position requires broad knowledge across all facets of development including pre clinical, clinical, manufacturing (CMC), and regulatory.

JobID: 200UD

UNC Lineberger Comprehensive Cancer Center

  The Advanced Cellular Therapeutics (ACT) Facility is a Good Manufacturing Practices (GMP) facility focused on expansion and manipulation of human cells for clinical applications, including the manufacturing of chimeric antigen receptor (CAR) T cells, therapeutic vaccines and other cellular products. This position will serve as a chemistry, manufacturing and control (CMC) medical writer for products produced within the ACT Facility. This individual will author the CMC sections of initial IND applications, amend the CMC sections and prepare annual reports. This individual will work across the portfolio to identify required differences in production and standardize procedures. This position will author technical SOPs and assist in performing quality assurance of SOPs. This position will perform regulatory strategic planning by working with investigators and ACT leadership to identify key validation elements and SOPs to ensure successful FDA review and identify shortcomings.

JobID: 20037409

Regulatory Affairs Specialist (Labeling/Promotions/Registrations)
Medical Device/Direct Hire

  An outstanding foot-in-the-door opportunity for a sharp, knowledgeable and self-directed Regulatory Affairs Specialist who will be responsible for maintaining the regulatory aspects of labeling, drafting new and revising existing artwork, as well as providing support for other regulatory affairs activities. Our client is one of the fastest-growing medical device companies in the Triangle with products being marketed in the US and Europe.

  Scion NeuroStim has created a non-invasive neuromodulation device (TNMTM) for treating a range of neurological diseases. TNMTM has been cleared for the treatment of episodic migraine headache. Other indications for use, including Parkinson’s disease and Alzheimer’s disease, are under development. The TNMTM device is being optimized for manufacturability. Scion is located in the RTP region of North Carolina. We are seeking an experienced clinical trials professional to become the Manager of Clinical Operations at Scion. The successful candidate will have had significant involvement in multi-site clinical trials and logistical support. He or she will work in a coordinated fashion with Scion’s regulatory, quality and manufacturing teams to ensure smooth and integrated cross functionality. Project Management skills a must.

Contact Claudia Black at [email protected]

  Scion NeuroStim has created a non-invasive neuromodulation device (TNMTM) for treating a range of neurological diseases. TNMTM has been cleared for the treatment of episodic migraine headache. Other indications for use, including Parkinson’s disease and Alzheimer’s disease, are under development. The TNMTM device is being optimized for manufacturability. Scion is located in the RTP region of North Carolina. We are seeking an experienced manager who will lead the planning and execution of Scion’s clinical studies. A planned Parkinson’s disease RCT, called STEM-PD, will be the first focus in our development program. She or he will ensure that the Company’s clinical trials, products and services comply with all national laws and regulations that may govern them. The successful candidate will represent the Company before regulatory boards and outside reviewers and auditors.

Contact Claudia Black at [email protected]

  Scion NeuroStim has created a non-invasive neuromodulation device (TNMTM) for treating a range of neurological diseases. TNMTM has been cleared for the treatment of episodic migraine headache. Other indications for use, including Parkinson’s disease and Alzheimer’s disease, are under development. The TNMTM device is being optimized for manufacturability. Scion is located in the RTP region of North Carolina. We are seeking an experienced Quality Systems professional to become the Manager of Quality Assurance. The successful candidate will ensure coordination between Scion and its contract manufacturers and follow all quality controls and SOP’s as per the Quality Agreements. She or he will undertake planning, directing and coordinating quality assurance programs and formulating quality control polices to improve efficiency, profitability and reduce waste.

Contact Claudia Black at [email protected]

  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.