Date Posted

Company

Position

  Syneos Health is a 23,000 person global Biotech and Pharmaceutical solution Provider. We help companies big and small by shortening the distance from Lab to Life. We have an executive opportunity for the North American Head of Regulatory Strategy and Consulting. In this role you will lead a team of experienced Scientific and Regulatory professionals to provide Regulatory strategy and expertise to our customers, to help them get their newly developed products into the hands of patients who need them. We provide everything from CRO through commercial consulting and commercialization. We need you as the head of Regulatory to help ensure commercial success.

JobID: 1937

  CROMSOURCE is looking for a GCP Quality Assurance Manager for Waltham, MA or Cary, NC. 3-5 years of experience as a GCP Manager, site document auditing and SOP Guidelines.

JobID: 1277

 This person will be a key member of the Development organization and interface with Cell and Gene Therapy personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators). The technical writer works with Quality and Regulatory personnel to ensure compliance with US, EU, and ICH requirements. Incumbent may be expected to perform :

* Maintains consistent high quality and efficiency in the generation of technical documentation including clinical, nonclinical, and CMC to support regulatory filings

* Assists with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and orphan drug applications for cell and gene therapy programs

* Supports clinical trial readiness by working with clinical operations and CROs as needed for generation/review/editing of clinical study documentation including IRB/IBC communications/responses, study manuals, etc.

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  The Regulatory Specialist is responsible for planning, organizing, and implementing strategies and activities required to procure regulatory approval for new and revised product lines, while maintaining Quality and Regulatory compliance with standards and regulations that govern the design, development, manufacturing, and distribution of medical devices. Focus is on surgical devices and implantables. Experience in a quality system is a must. Experience with change control and/or sterilization is a plus. Strong growth necessitates the need for additional staff.  This is an onsite position located in Rochester, NY.

Full Scale Solution, Inc

  Provide regulatory strategic input to teams in US, EU and Canada. Develops regulatory strategy(s) for interactions with health authorities to support objectives. Provides input to target labeling content and to product life cycle issues. Review and the final sign-off of regulatory submissions for assigned products/projects. MD or Ph.D. in a science-related field with 5 yrs drug development/regulatory experience and with interacting with Health Authorities. Experience with IND and NDA submissions.

Please submit resume to Clare Cormier at [email protected]

SLI Associates, Inc.

  SLI Assoc. has an opportunity for an AD or Sr. Mgr., CMC Biologics Regulatory Affairs at a Global Pharma Co. (up to $180K Base/20% Bonus/$15K LTI). The candidate will possess strong working knowledge of the development and/or manufacture of biologics (mAbs) compounds including characterization, comparability, process validation and control strategy, and stability. He/she will also have experience in making regulatory submissions, dealing with regulatory agencies, Module 2.3 preparation, and assisting in preparing Module 3.

Please contact Barry Grossman at [email protected]

Syneos Health

  The Director, Regulatory Strategy-Consulting & Submissions will be responsible for the management and development of the regulatory management team and staff. You will interact with senior management and staff on operational procedures and processes within the Regulatory department to ensure compliance. You will direct and oversee all regulatory aspects of clinical product development including, but not limited to, preparing and reviewing regulatory submissions (such as INDs, NDAs, IMPDs, CTD, eCTDs), reviewing clinical site regulatory documents, assisting executive management with the administration of the Regulatory Affairs Department, developing work flow, and regulatory records document processes.

JobID: 1072

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.

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