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UPCOMING EVENTS

US RAC Workshop
Registration is now open! Register!
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2018 Spring Symposium
May 16, 2018
 
The Wild Ride of Biotech:
Startups, Spinouts, IPOs, and Nonprofits  
 
Speaker: 
Dr. Ben Yerxa

CEO at Foundation Fighting Blindness

 

Register HERE

 

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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

  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.   
  5/1/2018 Veristat Vice President, Regulatory Affairs
Participating as a critical part of the core leadership team of Veristat, this position is responsible for the leadership and strategic direction of the global Medical Writing and Regulatory Affairs teams. Key client oversight and strategic project contribution combined with management of a group of Directors makes this role a critical contributor to the overall success and future growth of Veristat, not only through leadership of Medical Writing and Regulatory Affairs but through significant contribution to the wider company direction and management, including new business development. 
  4/13/2018 Novartis Regulatory Affairs Associate

  Prepare/submit regulatory documents. Monitor/track requirement changes. Compile/review Amendments, Supplements, Annual Reports. Interact with business units to obtain documentation required for submissions. Evaluate changes to regulatory documents via change control process. Review ANDA labeling documents. Maintain compliance w/ regulatory requirements for generic drugs. Maintain Regulatory Databases. Identify/resolve routine problems. Adhere to cGMPs, company policies, and quality requirements

Job ID: 229123BR

  4/2/2018 Nupulsecv Regulatory and Clinical Specialist
NuPulseCV, a medical device company is seeking a Full Time Regulatory and Clinical Specialist (40 hrs/week) that has experience in a fast pace setting. We¿re a close, family-oriented company, with a focus on goals and milestones. If you¿re interested, please send resume and a summary of why you are interested in the position to [email protected] Summary: This position will primarily be responsible for managing Regulatory Affairs with support for Clinical as needed. The distribution of duties will be 75%/25% across the two functions. Regulatory Affairs 1. Implement and execute regulatory strategies developed by senior management. 2. Prepare, review, edit, organize, and submit regulatory submissions, including FDA IDE submissions, pre-submissions, and periodic reports; Health Canada ITA submissions and periodic reports; CE Mark Technical Files; and other international regulatory submissions as directed. 3. Interface with regulatory agencies, consultants, and internal team members. 4. Provide regulatory leadership to internal project teams. 5. Develop and maintain internal operating policies and procedures related to regulatory affairs. 6. Maintain regulatory affairs documentation, trackers, and systems including the Regulatory Master File. 7. Evaluate changes to controlled documents for impact on submissions and filing requirements, including providing technical review and approval of proposed changes and supporting documentation. 8. File, organize and maintain company records both electronically and manually as needed to comply with ISO-13485 and/or 21 CFR 820. 9. Perform additional duties in compliance with applicable regulations, including FDA Quality System Regulations, GMPs, ISO 13485, Canadian Medical Device Regulations, and other international regulatory requirements, as applicable. Clinical Affairs 1. Support clinical affairs by performing duties as assigned, including managing trial documentation and interfacing with CRO and/or site personnel to manage trial operations. 2. Assist in development and management of clinical trial protocols. 3. Review clinical trial materials including instructions for use, patient information material, and training materials for clinical content. Qualifications 1. Minimum of BS degree in a scientific field, engineering preferred 2. 5-10 years of experience, medical device regulatory affairs preferred 3. Understanding of US FDA IDE and Quality System Requirements, ISO 13485, and Canadian Medical Device Regulations 4. Excellent organizational and multi-tasking skills 5. Flexible and adaptable in a fast-paced, start-up environment 6. Excellent verbal and written communication skills, including the ability to develop and present technical information 7. Demonstrated project management abilities
 

 

 

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