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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(US) Workshop Seminar Series
Tuesdays starting June 6, 2017 and continuing until September 26, 2017, 6:00 - 8:00 pm

Location: DCRI, The Lower Level Conference Room (NOTE: This is NOT the Downtown Office)

See Here for 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

  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

 

 

 

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