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US RAC Workshop
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2018 Spring Symposium
May 16, 2018
The Wild Ride of Biotech:
Startups, Spinouts, IPOs, and Nonprofits  
Dr. Ben Yerxa

CEO at Foundation Fighting Blindness


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ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2017

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Job Postings


Date Posted



  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
   03/13/2018 Unc 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.
  03/13/2018  Mindlance RA Specialist
  RA Specialist Location: Raleigh, NC Duration: 12 Months ( Possibility of Extension) JOB DETAILS: Assist in SOP development and review * Provide regulatory input to product lifecycle planning * Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes * Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval * Determine trade issues to anticipate regulatory obstacles Determine and communicate submission and approval requirements ¿ Participate in risk-benefit analysis for regulatory compliance Premarket: * Monitor applications under regulatory review Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies * Assist in preparation and review of regulatory submission to authorities Postmarket: Maintain annual licenses, registrations, listings and patent information * Assist compliance with product postmarketing approval requirements Assist in the review of advertising and promotional items * Assess external communications relative to regulations * Review regulatory aspects of contracts * Assist with label development and review for compliance before release * Submit and review change controls to determine the level of change and consequent submission requirements * Contribute to the development and functioning of the crisis/ issue management program * Ensure product safety issues and product-associated events are reported to regulatory agencies * Provide regulatory input for product recalls and recall communications Job specific responsibilities may include (choose applicable areas and expand as appropriate); * Medical writing * Advertising and promotion * Labeling * Controlled substances (e.g. DEA) * Restricted substances (e.g. REACH) * Compendial / standards * Import / export * Country specific regulatory support QUALIFICATIONS * Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred * Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) * 2-3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred * Regulatory history, guidelines, policies, standards, practices, requirements and precedents * Regulatory agency structure, processes and key personnel * Principles and requirements of applicable product laws * Submission/registration types and requirements * GxPs (GCPs, GLPs, GMPs) * Principles and requirements of promotion, advertising and labeling * Domestic and international regulatory guidelines, policies and regulations * Ethical guidelines of the regulatory profession, clinical research and regulatory process 
  03/13/2018 Unc Lineberger Comprehensive Cancer Center Regulatory Manager
The Clinical Protocol Office (CPO) at Lineberger Comprehensive Cancer Center (LCCC) is recruiting a second Regulatory Manager to join our fast paced office. The Regulatory Manager is responsible for performance management of CPO 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. This posting can be accessed directly by applicants at
  3/13/2018 Roivant Sciences Director Medical Devices Global Regulatory Affairs
The Director or Associate Director will be responsible for informing regulatory policies and leading the development and execution of global regulatory strategies for medical devices or assigned drug-device combination development programs. The successful candidate will maintain focus on corporate goals while responding to the needs of project teams in a highly dynamic, fast-moving environment.
  3/13/2018 Roivant Sciences Associate Director, CMC, Global Regulatory Affairs
The Associate Director of CMC Global Regulatory Affairs will be responsible for CMC regulatory activities and will contribute to the development, planning, and execution of successful regulatory strategies for innovative medicines that meet company objectives, differentiate from competitors to bring added value to patients, and enable optimal market positioning and commercial success in key markets around the world.  
  3/13/2018 Roivant Sciences Associate Director, Global Regulatory Affairs 
The Director or Associate Director, Global Regulatory Affairs will be responsible for leading the development and execution of global regulatory strategies for innovative medicines that address unmet medical needs and bring significant value to patients in diverse therapeutic areas. A successful candidate will maintain focus on corporate goals while responding to the needs of project teams in a highly dynamic, fast-moving environment.
  3/13/2018 Roivant Sciences Director/Senior Director,Global Regulatory Affairs
The Senior Director or Director will be responsible for leading the development and execution of global regulatory strategies for innovative medicines that address unmet medical needs and bring significant value to patients in diverse therapeutic areas. A successful candidate will maintain focus on corporate goals while responding to the needs of project teams in a highly dynamic, fast-moving environment. 
  3/14/2018 Srg Woolf Group Associate Director of Regulatory Affairs 
One of my top sponsor/pharmaceutical clients in the Raleigh-Durham area is currently searching for an Associate Director of Regulatory Affairs to join their team in their oncology department to assist with oncology related trials. This is a full time/permanent position and includes excellent benefits (100% paid by the company for the individual), a generous PTO/Holiday/Time off package, and other incentives including a 50%, 6.5% match on their 401k plan. This client is a smaller sponsor company so the possibilities for growth are endless. 
  3/14/2018 Carolina Liquid Chemistries Corp Director of RA/QA
The Director of RA/QA directs, manages, and participates in the daily activities of the Regulatory Affairs and Quality Assurance Department. Duties and responsibilities of this position include, but at not limited to the following: * Register all CLC with the FDA and other governmental agencies, in an accurate and timely manner * Pass FDA inspections * Pass ISO inspections * Keeps Organization informed of changes in FDA regulations and other quality regulations * Ensures that Organizational activities are in compliance with 21 CFR 820, cGMP and any appropriate governing agencies * Maintain the SOP system * Manage Document Control System * Follows Current Good Manufacturing Practice (cGMP) document control processes * Ensures the accuracy and completeness of the QS document system * Reviews and approves all labeling for compliance * Review and approve documentation change requests * Prepare and provide regulatory documentation needed for product export * Responsible for coordinating and implementing Internal Audits and Management Review (in conjunction with Senior Management). * Assures that FDA activities, including submissions, are completed in an organized and timely manner and in line with requirements for medical devices * Support and execute all quality management and compliance activity * Assist RA/QA functions and offers feedback for continuous process improvement and effectiveness * Process, coordinate, initiate, review, investigate and close complaints in conjunction with Technical Support, Service Coordinators, R&D, Production and all other departments * Assures that all products receive 510(k), CLIA categorization, or are in complaint with the Replacement Reagent and Instrument Family Policy, where appropriate * Upon completion of R&D activities, completes 510(k) submittals in a timely manner as specified by Senior Management * Maintain the Quality System * Ensures that all Validations are documented per the regulation * Responsible for Managing Risk Assessments for products and processes * May be selected as Management Representative; however in the event of an FDA audit, a Director of the Board must be present. The CEO or COO of the company may only sign official correspondence to and from the FDA unless a designee is given written expressed authorization to do so. * Assist in various business activities as assigned by management from time to time * Maintain ISO Certification 
  3/14/2018 Rti International Senior Scientist - Drug Development
RTI International is currently seeking a Senior Scientist with a background and interest in drug development. This individual will fulfill a key role as 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. The Senior Scientist will be responsible for the design and conduct of preclinical programs to support progression of novel therapeutic agents through the drug development process. Responsibilities  Plan and oversee preclinical drug development activities (eg., toxicology, ADME, CMC, or regulatory) for drugs, biologics, or devices for clients. * Provide drug development strategy and regulatory guidance for client's projects. * Develop and oversee execution of integrated drug development plans emphasizing strategically timed concurrent nonclinical, clinical, manufacturing, and regulatory activities. * Prepare or assist in preparation of specified sections of regulatory documents and INDs and provide responses to regulatory authorities. * Working with a project manager, ensure maintenance of each development program's applications, documentation, per regulations. * Oversee CRO and consultant activities and ensure deliverables are prepared or conducted on time and of high quality. Review study reports and related documents for compliance with regulatory requirements and good scientific principles. * Communicate effectively with clients through oral or written presentations. * Provides expertise and strategy to multi-functional project teams as a nonclinical specialist. * Ensures compliance with GLP, GMP, and regulatory guidelines. * Conduct internal (i.e., within RTI) and external business-development activities to raise profile of Global Health Technologies drug development capabilities. These activities will include the preparation of proposals for submission to funding agencies. Minimum Qualifications: * MS degree in chemistry, toxicology, metabolism, biology or related field with 12 or more years of experience or PhD with 8 or more years of experience in drug development activities. * Experience conducting, managing and/or monitoring nonclinical development activities, for example, reviewing/writing protocols and study reports. * Experience in writing and reviewing CMC or nonclinical sections of regulatory submissions including IND briefing documents and IND applications. * Familiarity with GLP requirements and ICH guidelines. * Ability to lead and work as a member of multiple project teams. * Excellent oral and written communications skills. * Ability to lead and work as a member of multiple project teams, and negotiate and achieve consensus in diverse groups. * Ability to prioritize and multi-task concurrent project demands
  3/14/2018 Rti International Regulatory Affairs Clinical Scientist
RTI International is currently seeking a Regulatory Affairs Scientist with a background and interest in clinical affairs as it relates to 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 guidance, supplemental writing, and review of clinical reports and pertinent regulatory submission sections for multiple concurrent drug, and biologics 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: * MS degree in biology, chemistry, nursing or related field with 12 or more years of experience; or PhD with 8 or more years of experience in drug development activities to include a focus on clinical affairs. RAC certification a plus. * Experience with FDA drug and biologics development and experience interacting productively with regulatory authorities. * Experience with clinical trials, maintaining essential documents, reviewing/writing protocols and clinical study reports. * Excellent oral and written communications skills. * Ability to lead and work as a member of multiple project teams, and negotiate and achieve consensus in diverse groups. * Ability to prioritize and multi-task concurrent project demands. * To qualify, applicants must be authorized to work in the United States. 
  8/8/2017 DCRI Sr. Medical Writer

This role has the potential to turn into a full regular position! The Senior Medical Writer will be responsible for planning, writing, and editing submission documents across multiple therapeutic areas and in compliance with ICH, FDA, and global regulatory guidelines and requirements. Assignments will include acting as coordinator and lead writer in the compilation and writing of clinical study reports, summary sections of regulatory submissions, protocols and investigators brochures for investigational drugs, devices, biologics and/or combination products.

  7/25/2017 Manpower Import/Export Compliance Program Supervisor
Chemial Import/Export Compliance Program Supervisor position will serve as the Subject Matter Expert and the primary internal contact for chemical product import/export regulatory compliance. Implement and maintain process to comply with US regulations for the movement of goods from the US to Brazil and other Latin American countries. Research pharma and chemical regulatory legislation and guidelines regarding DEA, EPA, EAR,ITAR,TSCA,NRC,DOT. Evaluate and update compliance database. Compile data and complete regulatory submissions to governmental agencies. Manage third-party compliance service provider relationships and projects. Coordinate and negotiate with regulatory authorities. Develop US Freight Forwarder requirements, documenting SOP's. Manage processes to secure and retain Powers-of-Attorney for export companies with Freight Forwarders. REQUIRED to have a 4-yr degree in a science field, 4 yrs exp in regulatory affairs, import/export, min of 2 years in International Trade Compliance. Knowledge with Import: CFR19 - Customs Duties, DEA. Understanding of chemistry testing methods, chemical characterization, supply chain processes, transportation, Global Trade Mgmt, Licensed Customs Broker and/or Certified Export Specialist is preferred.  Job ID 2258362
  7/25/2017 Manpower Chemical Import/Export Compliance Specialist

Specialist will serve as primary internal contact for chemical product import/export regulatory compliance. Receives, organizes, audits, prioritizes, processes and verifies information pertaining to goods manifested for shipping to clients. Follow all required pharma and chemical regulatory legislation/guidelines re: DEA, EPA, EAR, ITAR, TSCA, NRC, and DOT. Interact with clients, suppliers, US Customs Brokers and mgmt. REQUIRED: 4-YEAR DEGREE in science field and 2 yrs exp in regulatory affairs and 1 year International Trade Compliance. Understanding of various analytical chemistry testing methods and US Pharmacopeia Methods and Validation techniques, exp with AES and formal Entry. Basics with MS, GC, LC/MS, FTIR, UV-VIS; chemical characterization (NMR, Mass, IR, KF) and other associated assays including Chromatographic columns and Reference standards.

Job ID 2197666

  7/10/2017 Nupulsecv Regulatory and Quality Affairs - Medical Devices

Implement and executive regulatory strategies developed by the senior management team * Participate with all internal teams to implement overall regulatory strategy * Lead preparation of, including writing, organization, and submission of all regulatory documents in US and outside US, may include IRB and CMS submissions, as assigned. * Interface with regulatory agencies, consultants, internal team members * Maintain regulatory and quality documentation including Regulatory Master File and Design History File * Direct quality systems efforts. Duties include developing and maintaining internal operating policies and procedures related to regulatory and quality affairs for the company. * Ensure that the company is in compliance with FDAs Quality Systems Regulations, GMP's, etc. * Support clinical affairs, performing duties as assigned. Clinical duties may include managing trial documentation, interfacing with CRO to conduct trial and site operations.