Become a New Member!

Post a Career Opportunity

List a Professional Resource

Membership Renewal


Having Trouble?

Trouble with Membership Renewal?

UPCOMING EVENTS

US RAC Workshop
Registration is now open! Register!
****************
September 2018 NCRAF Event
Sep 20, 2018
 
Bench to Clinic:
Preparing for a Successful Translation
 
Speakers: 
Dana Minnick and Scott Burian

Rho, Inc.

 

Register HERE

 ===================== 

ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2018

Click to see details 

 ==========================

 

 

PDF Email

Job Postings

 

Date Posted

Company

Position

  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 

 

  8/27/2018 Gencoda 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. Our client seeks experience generally evidenced by prior work history with a small medical device company or medical device consulting firm in both a regulatory affairs and quality assurance capacity.

  8/27/2018 Axovant Sciences Vice President, Regulatory Affairs, Gene Therapies

A key member of the R&D leadership team, this position will lead and manage the company¿s global regulatory affairs organization. , This position is responsible for all regulatory activities, including but not limited to regulatory strategy, CMC regulatory, regulatory operations, labelling and promotional review, etc. Must lead by example and drive the regulatory strategy with the capability to both manage and execute the day-to day-operation of the Group This position will be responsible for both the gene therapy and small molecule aspects of regulatory affairs. Job ID: 150

  8/14/2018 Rti International Senior Regulatory Affairs Scientist

RTI International is currently seeking a Senior 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. Minimum Qualifications: Ph.D. in a scientific or technical discipline with 6+ years' experience in biopharmaceutical drug development or clinical affairs; OR a Master's degree with 9+ years' relevant experience OR a Bachelors' degree with 12+ years of relevant experience.  Job ID 180m8

 

   8/9/2018 Zingaro, Fidler, Wolfe & Company VP Regulatory Affairs and Quality Assurance

This newly created position following several acquisitions, reports to the Chief Executive Officer and works closely with the Chief Technology Officer. As a member of the Senior Leadership Team, you will work closely with the CEO and other members of the Senior Leadership Team to ensure successful attainment of all business goals and objectives.

  8/8/2018 Rti International Regulatory Affairs Scientist

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: 180fh

  8/2/2018 Advanced Recruiting Partners, LLC Regulatory Affairs Consultant

 A Biopharmaceutical company in Raleigh is looking for a Regulatory Affairs Consultant for a 6 month renewable contract. Ideal candidate will have the following: * New IND submissions * Maintenance of IND submissions * Strong scientific background * Meeting package preparation (preIND, end of phase 2) * Working in document management system * Submission management (tracking documents, managing timelines) * Protocol development, participation on clinical study team * Familiarity with NDA/BLA requirements (eg. CTD structure) * Experience with Health Canada submissions: CTA and CTA-amendment, CTSI.

Contact: Email: [email protected];  Phone: 678-654-4738

  6/25/2018 Merz Regulatory Affairs Manager

  The Regulatory Affairs Senior Manager develops and executes regulatory strategies for new products and life cycle management of existing products. Acts as primary contact for regulatory on cross functional product development and post-marketing teams and leads submission activities throughout product development and life cycle.

JobID: Regul01525

  6/18/2018 Unc Lineberger Comprehensive Cancer Center Assist. Director, Reg. Affairs & Quality Assurance
The UNC Lineberger Comprehensive Cancer Center (LCCC) oversees and coordinates oncology clinical trial research for the UNC School of Medicine and UNC Cancer Care. The UNC Lineberger Oncology Clinical Protocol Office (CPO) is primarily responsible for organizing, managing, conducting, and supporting these trials. Working with the CPO Medical Director and the LCCC Associate Directors, the Assistant Director of Regulatory Affairs and Quality Assurance oversees CPO regulatory operations, national compliance and reporting requirements for oncology clinical trials associated with the Cancer Center. The position also oversees the Quality Assurance Program, which encompasses monitoring, auditing, and training programs to ensure the highest level of quality in the clinical research conducted at the Lineberger Comprehensive Cancer Center. The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer.  JobID: 20018552
  6/13/2018 Polaris Compliance Consultants, Inc. Part 11 / CSV Auditors (Independent Contractors)
Conduct Part 11 / CSV and system-related vendor audits to ensure CSV activities and a company¿s use of electronic records are in compliance with internal procedures, policies, and applicable international guidelines and regulations. Participate in planning and reviewing business proposals as requested; provide input regarding the feasibility of time lines, budgets, and resources available for projects. Provide input regarding proposed training, auditing, and/or SOP writing activities. 
  6/13/2018 Polaris Compliance Consultants, Inc. GDPR Consultant (Independent Contractor)

Assist Polaris Compliance clients with their compliance with GDPR regulations. Participate in planning and reviewing business proposals as requested; provide input regarding the feasibility of time lines, budgets, and resources available for projects. Provide input regarding the implementation of GDPR.

  6/6/2018 The Select Group Regulatory Affairs Specialist - Medical Devices
The Select Group is seeking a Regulatory Affairs Specialist to join the team of a leading medical device company in Morrisville, NC. If you have experience with 510(k) submissions and supporting regulatory compliance of medical devices under 21 CFR and ISO 13485 standards please apply now!
  6/5/2018 G1 Therapeutics, Inc. Associate Director, CMC Regulatory Affairs
G1 Therapeutics, Inc. (a publicly-traded, clinical-stage biopharmaceutical company located in Research Triangle Park, NC) seeks your talents as our Associate Director, CMC Regulatory Affairs, to join our highly collaborative team as we significantly ramp up during this exciting period of our growth. Lead and manage CMC Regulatory Affairs activities, including development of regulatory strategy and submission planning. Position requires experience with INDs, CTAs, as well as marketing applications. Experience leading health authority meetings, including strategy and package development, is required. Be a part of our talented, driven team in bringing important new medicines to cancer patients in need.   
 

 

 

.