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December 2018 NCRAF Event
December 13, 2018
GDPR:  What We (Think) We Know So Far


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These meetings have resumed as quarterly get togethers for 2018

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Job Postings


Date Posted



 02/06/2019 Omeros Senior Director, Regulatory Affairs

Omeros, in beautiful Seattle, Washington is a growing and dynamic organization. We are seeking a Sr. Director, Regulatory Affairs to join our Regulatory Affairs team. In this position, you will be responsible for leading the Regulatory Affairs function. This includes Regulatory CMC, Regulatory Managers, Regulatory Operations, Technical Writing, and Pharmacovigilance. In addition to oversight and management of the Regulatory Affairs function, you will be responsible for developing and implementing the regulatory plan for key programs.

  1/30/2019 Duke Office Of Regulatory Affairs And Quality (ORAQ) QUALITY ASSURANCE ASSOCIATE I

  The QA Associate I will perform a variety of duties in support of the GMP programs at Duke University, including critical review and composition of deviations and investigations, review/revision of SOPs, release of materials, qualification of critical suppliers, review of product release, audit of programs under ORAQ's purview, and quality training. This position will be focused on support of the Molecular Products and Cellular Therapies (MPACT) GMP Facility at Duke University and will consult with manufacturing operations staff, as applicable/requested, to serve as a resource.

JobID: 401522175

  1/24/2019 G1 Therapeutics Associate Director,
CMC Regulatory Affairs

 Primary Responsibilities: * Lead efforts for coordinating CMC content for original INDs, IND amendments, IMPDs, for inclusion in Clinical Trial Applications and NDAs * Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, DSURs and background documents for Regulatory Authority meetings * Provides strategic CMC regulatory interpretation and guidance to project teams * Facilitate and deliver the regulatory strategy to support the lifecycle of assets (accountable for execution of CMC aspects). * Manage and contribute to CMC projects, initiatives & actions along with prioritizing assigned workload appropriately. * Manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects. * Serve as CMC representative on a cross-functional project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria. * Manage regulatory issues, maintain submission information in relevant CMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision. * Serve as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects. * Develop relationships with regulatory authorities to improve G1's regulatory success. * May participate in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions. * Demonstrate ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects. * Develop effective relationships across G1, ensuring all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.


  1/24/2019 G1 Therapeutics Associate Director,
Regulatory Affairs

  Primary Responsibilities: Reporting to the VP, Global Regulatory Affairs the primary focus of the Associate Director, Regulatory Affairs role will be to provide support for the regulatory affairs department, with a primary focus on clinical development activities such as clinical trial activation and management, IND and CTA submissions/amendments, and health authority interactions. The role will closely interact with multiple functions leading projects and regulatory initiatives, and creating high quality regulatory submissions that support G1*s product development strategy. Key activities include (or may include): * Leading regulatory submission planning and coordination, including the preparation of regulatory submission documents, and reviewing regulatory submissions for completeness and quality in accordance with regulatory agency requirements, standards, and corporate practices * Play a key role in the development of global regulatory strategy regarding overall development plans * Responsible for maintaining active IND/CTAs, including timely coordination of responses to health authority questions/comments * Representing the regulatory affairs function in study teams to provide regulatory support and advice * Interacting with corporate partners, CROs, and vendors regarding various regulatory matters * Providing support for regulatory interactions, including health authority meetings and teleconferences * Ability to troubleshoot situations as needed and understands when problems need to be escalated to the VP, Global Regulatory Affairs.


  01/14/2019 Chesapeake Utilities Corporation - Florida Public Utilities Regulatory Analyst 3

  The Regulatory Analyst 3 is responsible for the preparation of all internal and external regulatory reports and analysis, inclusive of Florida Public Service Commission (FPSC) and other external regulatory requirements. This position also assists with financial analyses and special projects. The Regulatory Analyst 3 is responsible for developing new programs, rates, and other regulatory strategies.


  12/15/2018 Genecoda Regulatory and Quality Consultant

  Our client, a professional consulting services organization focused on medical device regulatory and quality compliance offers the opportunity to gain expansive portfolio experience found almost exclusively within a multi-client centered environment. Differentiating our client from other consulting firms is their dynamic environment, devotion to their people and focus on the people, processes, and technology leveraged to improve both their client's business and teams. Our client seeks experience generally evidenced by prior work history with a medical device company or consulting firm in a regulatory affairs capacity.

JobID: 1015

  12/10/2018 Syneos Health Head of Regulatory Strategy and Consulting

  Syneos Health is a 23,000 person global Biotech and Pharmaceutical solution Provider. We help companies big and small by shortening the distance from Lab to Life. We have an executive opportunity for the North American Head of Regulatory Strategy and Consulting. In this role you will lead a team of experienced Scientific and Regulatory professionals to provide Regulatory strategy and expertise to our customers, to help them get their newly developed products into the hands of patients who need them. We provide everything from CRO through commercial consulting and commercialization. We need you as the head of Regulatory to help ensure commercial success.

JobID: 1937

  11/27/2018 Cromsource Clinical Quality Assurance Manager

  CROMSOURCE is looking for a GCP Quality Assurance Manager for Waltham, MA or Cary, NC. 3-5 years of experience as a GCP Manager, site document auditing and SOP Guidelines.

JobID: 1277

  11/06/2018 Precision Biosciences Technical Writer, Regulatory

 This person will be a key member of the Development organization and interface with Cell and Gene Therapy personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators). The technical writer works with Quality and Regulatory personnel to ensure compliance with US, EU, and ICH requirements. Incumbent may be expected to perform :

* Maintains consistent high quality and efficiency in the generation of technical documentation including clinical, nonclinical, and CMC to support regulatory filings

* Assists with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and orphan drug applications for cell and gene therapy programs

* Supports clinical trial readiness by working with clinical operations and CROs as needed for generation/review/editing of clinical study documentation including IRB/IBC communications/responses, study manuals, etc.



  10/30/2018 LSI Solutions, Inc. Regulatory Specialist

  The Regulatory Specialist is responsible for planning, organizing, and implementing strategies and activities required to procure regulatory approval for new and revised product lines, while maintaining Quality and Regulatory compliance with standards and regulations that govern the design, development, manufacturing, and distribution of medical devices. Focus is on surgical devices and implantables. Experience in a quality system is a must. Experience with change control and/or sterilization is a plus. Strong growth necessitates the need for additional staff.  This is an onsite position located in Rochester, NY.


Full Scale Solution, Inc

Regulatory Strategy Leader 

  Provide regulatory strategic input to teams in US, EU and Canada. Develops regulatory strategy(s) for interactions with health authorities to support objectives. Provides input to target labeling content and to product life cycle issues. Review and the final sign-off of regulatory submissions for assigned products/projects. MD or Ph.D. in a science-related field with 5 yrs drug development/regulatory experience and with interacting with Health Authorities. Experience with IND and NDA submissions.

Please submit resume to Clare Cormier at [email protected]


SLI Associates, Inc.

Assoc. Dir. or Sr. Mgr., Biologic CMC RA

  SLI Assoc. has an opportunity for an AD or Sr. Mgr., CMC Biologics Regulatory Affairs at a Global Pharma Co. (up to $180K Base/20% Bonus/$15K LTI). The candidate will possess strong working knowledge of the development and/or manufacture of biologics (mAbs) compounds including characterization, comparability, process validation and control strategy, and stability. He/she will also have experience in making regulatory submissions, dealing with regulatory agencies, Module 2.3 preparation, and assisting in preparing Module 3.

Please contact Barry Grossman at [email protected]


Syneos Health

Regulatory Director
Medical Devices


  The Director, Regulatory Strategy-Consulting & Submissions will be responsible for the management and development of the regulatory management team and staff. You will interact with senior management and staff on operational procedures and processes within the Regulatory department to ensure compliance. You will direct and oversee all regulatory aspects of clinical product development including, but not limited to, preparing and reviewing regulatory submissions (such as INDs, NDAs, IMPDs, CTD, eCTDs), reviewing clinical site regulatory documents, assisting executive management with the administration of the Regulatory Affairs Department, developing work flow, and regulatory records document processes.

JobID: 1072

  9/10/2018 Lineberger Comprehensive Cancer Center  IND Specialist

The position requires that the individual provide guidance and training; be responsible for submissions of reports and communications with the FDA; support for IND submissions; submission of IND reports; writing informed consent forms; amending protocols; creating and maintaining professional working relationships with investigators, sponsors, team members, and others. These responsibilities relate to the mission of the UNC/LCCC Protocol Office by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.

  9/10/2018 Lineberger Comprehensive Cancer Center  Protocol Development Specialist  
This position will collaborate in writing, editing, producing and reviewing oncology clinical trials LOIs (letters of intent) and protocols. Priority of work is primarily self-directed with input and guidance from senior MD faculty in the clinical research program, and immediate supervisor.  JobID: 20001357
  9/10/2018 Frankel Staffing Partners   Regulatory Affairs Manager (Labeling/Promotions)


This Manager will be a deputy to the Head of Regulatory and Quality. Although the initial responsibilities will focus on labeling, the role will be diverse and dynamic. Seek candidate who enjoys contributing broadly. Company is developing several products that will be marketed in the US and abroad. Familiarity with US and ROW regulations and requirements will be important. As an emerging business, policies and practices are being developed and enhanced. Successful candidate will bring ingenuity, flexibility and drive. Specific responsibilities will include: *Assist in developing and implementing regulatory strategies for new and modified products * Provide regulatory expertise to colleagues and leadership. Help ensure regulatory compliance mindset within the company * Drive the coordination, development and execution of labeling projects (including obtaining labeling translations) for product portfolio