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UPCOMING EVENTS

NCRAF's Spring Summit will have a return engagement by former FDA Commissioner

Dr. Robert Califf

 

Wednesday, May 17, 2017

See details.

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RAC EU online Workshop

Register for the self-paced course starting Feb. 7, 2017 

Click to see details

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ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2017

Click to see details 

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Job Postings

 

Date Posted

Company

Position

  03/08/2017 Becon Hill Pharma Scientific Affairs Specialist I

  As a Scientific Affairs Specialist, you will be providing support to and be responsible for assessing and managing the regulatory impact of critical interfaces between PIC and internal and external stakeholders, and Third Party Regulatory Engagement processes and management. You will also be aligning all work with Regulatory and Scientific Affairs in the design, implementation and oversight of overall corporate regulatory initiatives.

Contact: Julliette Hilliard, 312.962.0171 or jhilliard@beaconhillstaffing.com

  03/08/2017 QuintilesIMS Principal Medical Writer
Home- or Office-based

  Lead the preparation of any type of clinical document, for either internal QuintilesIMS customers or external clients, for investigational drugs, biologicals, or medical devices to produce high quality documents. Minimum of Bachelor’s degree in a life science-related discipline, advanced degree preferable, with at least 5 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including extensive experience in preparing clinical study protocols and reports, with consistently positive customer feedback; or equivalent combination of education, training and experience.

JobID: 1704976

  03/08/2017 QuintilesIMS Medical Writer 2
Office-based in RTP, NC

  Lead the preparation of most types of clinical document, with senior guidance for either internal QuintilesIMS customers or external clients, for investigational drugs, biologicals, or medical devices to produce high quality documents. Minimum of Bachelor’s degree in a life science-related discipline, advanced degree preferable, with at least 2.5 years' of experience in a medical, clinical, preclinical, chemistry or related environment; or equivalent combination of education, training and experience.

JobID: 1705444

  2/28/2017 Premier Pharma
Executive Talent Sourcing
Director, Global Regulatory Strategist
 

  Our client, located in central NJ, is one of the top 10 pharmaceutical companies in the world. They have created a small ‘biotech-like’ entity with in their organization. The new group operates autonomously from corporate so it can streamline the drug development process. The client is hiring an experienced Global Regulatory Affairs person to lead their filing efforts in the therapeutic areas of Cardiovascular Disease, Fibrosis, Immunology, and Genetic Redefined Diseases.

This person will need to:

- Develop and lead Global Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement.

- Collaborate and influence internal expertise and external regulatory resources to assure regulatory issues are addressed in development plans

- Provide leadership to resolve critical regulatory project issues, bringing the appropriate regulatory experts together as needed to assist in the resolution

- Establish sound regulatory advice/position on key development issues, and communicate same to Development Team Lead and other team stakeholders

- Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources

- Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies

- Provide strategic regulatory input to key development documents and study reports, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents.

If interested, Contact Tony Fischetti, 215-660-3840 or tf@premierpharma.net

  2/17/2017 The Talent Solution VP Regulatory Affairs -
In Vitro Diagnostic (IVD) Devices
  A medical device company and a leader in developing advanced diagnostics technologies, is growing and looking for a hands-on VP of Regulatory Affairs with profound experience and knowledge in In-Vitro Diagnostic Devices. The VP RA will be responsible to all procedures and communications for obtaining US FDA clearance.
  1/25/2017 Quintiles Regulatory Affairs Manager
 

Manages a regulatory and/or technical project, for both internal and external clients, as appropriate. Provides strategic regulatory and/or technical consultancy on a variety of projects.

 • Acts as a Lead Regulatory Professional on any type of writing or technical project, with limited guidance from senior staff using experience and initiative to generate new and unusual document types to meet customer requirements.

 • Provides strategic regulatory and/or technical consultancy on a variety of projects and provides senior review and guidance for most documents prepared by junior colleagues.

 • May act as a Project Manager for a stand-alone project, with full project management responsibility.

 • May prepare a single service regulatory or technical proposal for senior review and/or propose budgets for less routine projects, out of scope activities and potential budget efficiencies. Deliver business development presentations to customers with confidence and detailed knowledge, as directed.

 • Independently meet with customers face to face to discuss project status. Identifies creative solutions to challenges that are acceptable to Quintiles and customers, thereby consistently receiving positive customer feedback.

 • Ensures compliance with regulatory processes, ensuring readiness for internal or external project audits.

 • May design training materials and deliver training externally and internally.

 • May represent region or site on a regulatory, technical or cross functional Initiative.

 • Performs other tasks or assignments, as delegated by Regulatory management.

JobID: 1625131

  1/25/2017 Inc Research Regulatory Consultant

Responsible for contributing to preparation of regulatory submissions for conduct of clinical trials, product registration, and post approval maintenance activities; participates on project teams. Responsible for day to day contribution to projects. Understands allocated project hours and tracks compliance. Monitors personal utilization. Interacts with internal personnel and technical experts on projects. Interacts with clients under guidance. Conducts regulatory research on projects as needed. Attends client meetings. Retrieves literature references as needed. Contributes to preparation of regulatory submissions for conduct of clinical trials, product registration, and post approval maintenance activities; participates on project teams. Participates in quality improvement efforts to increase overall operational efficiency.  

JobID: 16004051

  1/20/2017 Vanderbilt University Research Regulatory Affairs Manager

  Serves as the central resource to investigators to assist and provide guidance regarding Investigational New Drug (IND) development through experience with and knowledge of related federal regulations (FDA). Works closely and partners with investigators and internal departments to deliver safe and effective research designs for clinical trials in line with institutional policies and procedures and federal regulations. Provide quality assurance support with focus on compliance with methods, facilities and controls as they relate to federal regulations. Serve as a resource to investigators to assist and provide guidance and education regarding device development through experience with and knowledge of related federal regulations.

JobID: 1510506

  1/18/2017 RTI International Regulatory Affairs Specialist

  RTI International is currently seeking a Regulatory Affairs Specialist with a background and interest in drug development. The successful candidate will support project activities related to the development of new drugs to treat neglected diseases and for other unmet medical needs. The primary responsibility of this position will be to provide regulatory support to the Regulatory Affairs Lead. These tasks could include writing, formatting, compiling and maintaining supporting documentation/technical files in support of routine and complex regulatory submissions to the FDA. This position is located in the Research Triangle Park area of NC.

JobID: 17751

  12/8/2016 UNC Lineberger Cancer Center Regulatory Affairs Manager 

  The Regulatory Affairs Manager is responsible for performance management of the Lineberger Comprehensive Cancer Center (LCCC) Clinical Protocol Office Regulatory Staff. This supervisory role is comprised of staffing, work assignment, implementing the performance management program, supporting staff learning and development, leave management and schedules, and HR-related functions. This position is also responsible for the development and implementation of Regulatory Standard Operating Procedures. These responsibilities relate to the mission of the UNC/LCCC Protocol Office by addressing the regulatory compliance, thereby ensuring the quality of research and institutional integrity. Extensive knowledge of Federal Regulations required. CCRP, CCRC, CIRB or RAC Certification preferred.

JobID: 20018256

  11/18/2016 Novan Regulatory Affairs Manager

  The Regulatory Affairs Manager will work in close collaboration with line management and cross-functional project teams to develop and implement regulatory strategies and coordinate regulatory submissions, including nonclinical, clinical, and CMC. Working with internal scientific and technical departments as well as external vendors, the Regulatory Affairs Manager will be responsible for the preparation and submission of all regulatory documents, management of submission processes, and oversight of various regulatory tracking tools, timelines and infrastructure. In addition, this role will provide regulatory guidance to all departments and project teams.

Principal Responsibilities and Accountabilities: 1. Participate as Regulatory Affairs representative on assigned projects, and assist R&D teams by providing regulatory guidance and information across all relevant areas including nonclinical, clinical, and CMC. 2. Oversee and manage regulatory operations; collaborate with project teams to author and publish regulatory submissions, including formatting and compilation of paper and electronic submission documentation, and file by required due dates and in accordance with applicable regulations and guidelines. 3. Author documents for submission, including regulatory agency correspondence, documents for INDs and NDAs, and meeting briefing packages, and review and provide regulatory comments and advice for documents prepared by other departments. 4. Ensure documents for submission are in compliance with current regulations and guidance. 5. Provide regulatory assessment of manufacturing processes and changes, determine impact of changes on regulatory filings, and prepare appropriate IND amendments and NDA supplements. 6. Manage and track regulatory queries from regulatory agencies and collaborate with subject matter experts to provide written responses to questions. 7. Contribute to the review, implementation, and maintenance of the submission process and provide suggestions for ongoing process improvement. 8. Prepare for and participate in regulatory audits and inspections. 9. Maintain awareness of industry and regulatory developments and provide updates to regulatory and project teams.

  11/17/2016 FPC of Raleigh Executive Search Regulatory Affairs Manager

  This rapidly expanding and well-funded clinical stage pharma is seeking a Sr. Regulatory Affairs associate already based in the RTP, NC, area who is ready to take the next step up into a Manager of Regulatory Affairs role and thrives in a fast paced environment. This role would also get involved in regulatory affairs in a variety of therapeutic ares. Must have experience with managing/reviewing regulatory documentation (like IND filings or clinical regulatory documentation). Working with external contractors and other regulatory consultants (publishers, etc.) and RAC certification a plus. BS degree/MS/Ph.D. Preference for 5+ years of pharma industry experience (CRO or pharma). Candidates must already be based in the RTP area (no relocation assistance is available).

Contact Joanne Gehas at jgehas@fpcraleigh.com

 

 

 

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