My name is Ashley and I represent The Fountain Group. We are a national staffing firm and we have an opening for a Senior Regulatory Affairs Publisher. This contract position will be located in Lexington, MA and expected to be a 6+ month contract. Please see below for position details.
Manages and prioritizes the tracking, compilation, and quality-checking of submission component documents; publishes and reviews regulatory submissions and correspondence
Ensures compliance ...
Pharmalink Consulting is recruiting for a Regulatory Submission Manager who will coordinate all aspects of CMC regulatory submissions relevant to their assigned projects and serve as the regulatory CMC representative on matrix teams, as appropriate.
Duties and Responsibilities:
Monitor changes to development plans and work with supervisor to design globally compliant CMC regulatory strategy for development products with supervision.
Drive global CMC regulatory submission activities (IND, CTA, ...
Our client is looking for a project manager with IT regulatory experience in the biotech industry. The position is located in cambridge, MA.
Project Manager – Regulatory IT
The INSIGHT Project Manager is responsible for the planning and execution of business process improvement and regulatory information management project. The INSIGHT Project Manager will work with business process owners, information technology staff, and subject matter experts to lead business process ...
Our client is looking for a contracts manager in Weston, MA.
This role will oversee the GMA-Hemophilia group responsible for setting up a Contracts Management database, liaise with Finance and Legal groups to ensure financial and reporting obligations are achieved for each agreement; monitoring and tracking all contract obligations, including event alerts to ensure event completion.
-Must have strong understanding of Contracts and Outsourcing, including understanding of legal, ...
Responsible for input including: documentation, application forms, regulatory submissions (briefing documents/INDs BLAs/Post Marketing submissions, etc.)
Prepares and reviews local labels.
In consultation with Sr. Managers, contributes to regulatory interactions with local health authorities in the US and Canada.
Provides input into the development of regional RA strategies.
Monitors local guidelines and vaccine specific recommendations.
Prepares and/or comments on ...
Growing company seeks seasoned leader for GMP regulated Asceptic manufacturer. Director will strategize and execute all facets of manufacturing projects, which include cell culture, protein purification, and ready for distribution sterile packaging
** Develop capital budget and project costing; ensure that manufacturing activities are completed within budget and resource constraints.
** Direct scheduling, production set-up and clean up, following GMP regulations
** Ensure Continuous Quality ...
Seeking Senior level leadership experience. GMP regulated clinical and commercial manufacturer of Vaccine Grade Biologic products. Will be responsible for all facets of planning and execution of manufacturing operations.
** Ability to develop strategies for efficient and high quality production of antibodies, antigens, proteins and similar Biologics
** Thorough knowledge of GMP regulations
** Budget and resource management
** Experience with aseptic manufacturing and ...
Nov 14 -
eBay Classifieds provides a large number listings for biotech, R&D & science jobs in Boston, such as clinical research assistant jobs, laboratory director jobs, clinical technician jobs, senior device engineer jobs and mechanical design engineer jobs. Once you find a biotechnology, research development or science job that you are interested in, you should consider sending in your application. Include a full resume as well as a cover letter. You can do this by clicking on the reply put on the ad's page. Perhaps you are looking to move to the local region and you need to find a job as soon as possible.