Become a New Member!

Post a Career Opportunity

List a Professional Resource

Membership Renewal


Having Trouble?

Trouble with Membership Renewal?

UPCOMING EVENTS

 ===================== 

RAC EU online Workshop

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

Click to see details

==========================

ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2017

Click to see details 

 ==========================

 

 

PDF Email

Job Postings

 

Date Posted

Company

Position

  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.  

   6/13/2017 Seqirus Sr. Scientist- Regulatory Affairs

Will contribute to the vision and goals for GRA and Seqirus, by providing specialist advice and support to Project/Product teams, Quality Operations and/or Manufacturing Operations.  Interfaces with other functions in Regulatory Affairs and R&D and/or across the organization in Commercial Operations, Quality Operations and Manufacturing Operations, to ensure collaborative connectivity with these key stakeholders, and a focused regulatory approach to supporting country and regional business objectives, or global R&D objective.  The role will develop collaborative and respectful relationships with staff at the National Human Medicines Regulatory Agencies, and where applicable in licensing partners, to build and maintain credibility for Seqirus, as related to their products/project.

JobID: R-034357

   6/12/2017 Class Three, Llc Regulatory Assistant, Part-Time, Summer, $25/hr

A local medical device regulatory consultant is seeking part-time (10-12 hrs per week) assistance for the summer. The work is administrative in nature, with a strong focus on gathering regulatory and industry-related information from the internet, plus some basic administrative drudge work. Great experience for a business, engineering, or other student or recent grad interested in pursuing a career in an FDA-regulated industry, but consideration will not be limited to these candidates. Qualifications: - A general understanding of FDA regulation of medical products, medical devices specifically, a plus. - Experience researching and collecting scientific, technical, and/or regulatory information online required. Rudimentary knowledge of FDA website and databases, a plus. - Good internet search, MS Outlook, Word, Excel skills required. - Can bring your own laptop, a plus. - Location within 20 minutes of Southpoint a plus. - Information junkie, Asperger¿s tendencies, a plus. Must be available to work at least 5 hours a day two days a week or 3-4 hours three days a week sometime between 8:00am and 6:00pm. Specific days and times are flexible, but must work a stable schedule rather than winging it week to week. Start date no later than July 5, end date no earlier than August 18. Please email resume to julie@class3devices.com and address above qualifications in the email.

  JobID: Watchcat

  6/12/2017  Fortune Recruiting Director of Regulatory Affairs/Med Device

Our growing Medical Device client company is seeking a Regulatory Affairs Manager/Director to join their team in the Raleigh, NC area. The Regulatory Affairs Manager/Director will prepare regulatory submissions, to include 510(k) premarket notifications, EU MDD Technical Files, and other international registrations. The Regulatory Affairs Manager/Director will also ensure regulatory compliance will all applicable governing bodies. We are seeking a candidate who is able to think strategically as well as perform in a hands-on style with attention to budgets and timelines. This is a start-up company environment, so this individual will need to be able to wear multiple hats. BS degree is required, along with 10+ years of experience in medical device regulatory environments. Experience in ophthalmic medical devices is strongly preferred. This position will can be a Manager or Director level, depending on the candidate¿s experience level. 

JobID: Lc2

  5/12/2017 Chiltern Manager, Regulatory Affairs

  The Manager Regulatory Affairs is responsible for the preparation of clinical trial applications and the management of regulatory liaison activities with competent authorities. Ensure Chiltern’s data integrity standards, compliance with all regulatory requirements. Oversee the development, implementation, and consistent application of relevant regulations, regulatory guidance and precedents. Desired Experience: Post-graduate degree in Life Sciences preferred. Demonstrated ability to conduct Regulatory Affairs activities with the minimum of supervision.

JobID: 6386

  5/11/2017 Grifols Therapeutics Inc. R&D Regulatory Manager

  The successful candidate will work with subject matter experts in R&D and Clinical Development to develop and implement world-wide regulatory strategies for products under development and/or marketed products and will lead interactions with regulatory authorities.

Primary Responsibilities: * Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products, new indications for existing products Serves as a regulatory representative on cross-functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements * Provides regulatory expertise to R&D and Clinical Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical/clinical activities with regulatory strategies. * Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business. * Advises management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators' responses through scenario planning and development of contingency plans. * Ensures that documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements. * Writes and/or evaluates complex technical and scientific documentation required for regulatory submissions.

JobID: 38101

  5/2/2017 Lucerno Dynamics Director Quality and Regulatory Affairs

  Lucerno Dynamics (LD) has developed breakthrough technology to detect and quantify the dynamic uptake of radiolabeled biomarkers in tissue quickly, safely, and inexpensively. LD is commercializing the first application of this technology, the Lara system to provide quality control for injections of radiotracers used in nuclear imaging studies. The Director Q&RA is directly responsible for managing the Lucerno Quality System and leading the Regulatory Affairs function. This position reports to the Chief Operations Officer. This role will be responsible for the Lucerno Quality System in support of development, contract manufacturing, and commercialization of Lucerno products, and will develop and establish a Regulatory Affairs function to ensure Lucerno meets all requirements and receives approvals from appropriate regulatory agencies to produce and market its products globally.

Specific objectives: 1. Maintain the Quality System (QS) so that meets all applicable CFR, ISO, and MHLW standards based on Lucerno¿s activities. 2. Ensure that the format of the QS is designed to encourage compliance and that the QS is understood, implemented, and maintained at all levels of the organization. 3. Lead efforts to achieve ISO 13485 certification for Lucerno.  4. Maintain processes to measure, track, and report QS performance to Lucerno management.  5. Provide quality engineering support for product development, contract manufacturing, and post market support activities.  6. Develop and manage a supplier quality program and quality alliance plans with contract manufacturers.  7. Establish working relationships with relevant regulatory authorities and agencies, and act as liaison between Lucerno and external auditors or agents on all matters relating to the QS and Regulatory Affairs.  8. Determine, coordinate, and file all required product and company regulatory submissions to support commercialization plans.  9. Ensure that all Lucerno business maintains compliance with existing and evolving quality, regulatory, and safety requirements.

  4/27/2017 Womancare Global/DKT International Consultant QA Director -
Medical Devices

  This is an interim position for an experienced QA consultant on an as needed hourly basis. It is a contract consulting position responsible for the quality system for Class I and II medical devices distributed globally. The QA Consultant would be responsible for maintaining ISO 13485 certification for EU and Canada and QSR for US FDA and compliance for all global markets. The consultant would also define, plan, and oversee quality system strategic initiatives in support of immediate and long-term business needs. The individual will ensure that management, employees/contractors, vendors, and products are in compliance with rules and regulations for medical devices.

This is a remote position ideally located on the East coast of the US.

Contact Mary Jarosz (mary@jrsweb.com) for further information

  4/21/2017 INC Research Regulatory Consultant

  Provide regulatory and technical support for assigned product development projects, including product development documents and regulatory agency submissions, implementing/managing project regulatory activities, and supporting clients and project teams.

JobID: 16004051

  4/17/2017 Wep Clinical Regulatory Affairs Specialist

  The ideal candidate is an individual with previous experience who can maintain and develop WEP's current knowledge of processes that govern the movement of unregistered/unapproved pharmaceutical products. This person will forge links with local regulatory agencies in the Americas/ROW and maintain ongoing working relationships with key contacts at this level. They will also contribute to the company's regulatory function and assist project managers in gaining regulatory approvals for INDs.

  4/14/2017 Chimerix Vice President, Regulatory Affairs

  We are currently seeking a VP, Regulatory Affairs who will be responsible for developing and implementing our Regulatory Strategy. Based in Durham, NC, this role requires extensive experience interacting with the FDA and other regulatory authorities.

JobID: 2017-1109

 
  4/14/2017 FHI360 Regulatory Specialist II

  FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. FHI 360 serves more than 70 countries and all U.S. states and territories. We are currently seeking qualified candidates for a Regulatory Specialist II.

Experience with traditional IND submissions; knowledge of CTD and eCTD formats for regulatory submissions; registration of study and results in Clinicaltrials.gov;pharmacovigilance knowledge a plus; interest working in global clinical trials.

JobID: 18235

 
   3/29/2017 Fpc Of Raleigh VP of Regulatory Affairs

  The Vice President, Regulatory Affairs, will be a hands-on and strategic leader who enjoys a fast-paced, dynamic work environment. The VP of Regulatory Affairs will be responsible for providing regulatory leadership in support of the development, regulatory approval, and life-cycle management of products. He/she will provide leadership and develop strategies to ensure effective achievement of business objectives. The individual will also maintain awareness of current regulatory environment and assess and communicate impact of changes on business and product development programs. This position will report into a SVP.

Responsibilities: *Provide regulatory leadership in support of the development, regulatory approval, and life-cycle management of drug products *Ensure the efficient, timely and compliant execution of regulatory strategies *Provide review and comments on regulatory documents *Offer expert opinion, advice and strategic direction on emerging policy (orphan drugs, etc.). *Provide regulatory due diligence assessments of new business opportunities as required.

JobID: Vpreg204

 
   3/29/2017 Sandoz,
A Novartis Company
Manager, Regulatory Affairs

  Supervises and leads a team of associates to ensure regulatory activities for development and marketed products are achieved according to the agreed schedules and commercial objectives. Provides training and guidance to the Regulatory team. Provides Regulatory expertise and regulatory strategy for assigned projects.

* Contributes to and leads in the preparation of regulatory submissions such as ANDAs, DMFs, NDAs (505b(2)), Supplements, Annual Reports. * Reviews and approves changes made to pending and approved applications. * Reviews and provides input into updating regulatory processes to ensure accuracy and compliance. * Supervises regulatory activities to deliver timely results. * Provides Regulatory leadership to direct reports by coaching, mentoring and providing development goals. * Ensures policies and practices are reviewed and revised as needed. * Uses standard programs and systems, ensures accuracy and completeness of regulatory submissions, filings and filing systems. * Ensure department databases and filing systems for regulatory submissions are current. * Identifies potential issues and resolves routine problems. * Prioritizes work and receives general supervision and detailed instruction on new projects. * Uses judgement and policies to reach solutions. * Understands all company practices and interfaces with many management levels. * Performs other duties as assigned. * Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, etc.).

JobID: 208443br

 
   3/29/2017 Cato Research Ltd

Regulatory Scientist II

  Cato Research is a full-service contract research and development organization with international resources. We are currently seeking to fill a Regulatory Scientist position within our Durham, NC office.  In this role the Regulatory Scientist will have previous experience in drug, biologics and medical device development, have the ability to provide regulatory and scientific guidance and advice on projects, to evaluate potential new technologies, and to prepare business development proposals. The Regulatory Scientist will also have previous experience interacting with the regulatory authorities and will contribute significantly to strategic and analytical discussions and associated/reports with sponsors and internal team members. The Regulatory Scientist will have experience authoring, compiling, reviewing and submitting various industry documents such as, but not limited to, INDs, NDAs, BLAs, and clinical protocols. This is a non-laboratory position.

JobID: 1008

 
  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

 

 

 

.