Kirby Bates Associates, a national healthcare leadership firm, has an engagement opportunity for an Interim Manager/ Documentation Regulatory Specialist in Massachusetts at a residential and LTC facility. The leader must be able assist at the unit levels with hands-on monitoring and mentoring and ha...
In addition, this position will support the regulatory department by maintaining data within regulatory data systems, supporting regulatory projects and initiatives and by supporting ongoing regulatory operations. The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technica...
In addition, this position will support the regulatory department by maintaining data within regulatory data systems, supporting regulatory projects and initiatives and by supporting ongoing regulatory operations. The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technica...
You will report to the SVP, Global QA, RA & ESG and work closely with colleagues from R&D, Product Management & Marketing, QA&RA and other functions, to plan and perform regulatory submissions, product registrations/listings and renewals towards FDA, Health Canada and other Regulator...
The Regulatory Affairs Specialist will work closely with the Director of Regulatory Affairs to obtain and maintain global regulatory approvals to allow IPG to market its state of the art devices worldwide. The ideal candidate is a diligent, hardworking individual with 2 to 5 years of regulatory expe...
Our client is currently seeking a Senior Regulatory Compliance Specialist. Monitor international standards and guide regulatory testing requirements. Assist with risk analysis and regulatory submissions. ...
The Quality Assurance Manager works with other staff to establish procedures and quality standards and to monitor these against agreed upon targets. ...
New York Life Insurance Company is currently seeking managers to become part of our Fast Track Partner program. ...
The Specialist, Field Quality Assurance Manufacturing, is responsible for supporting shop-floor activities in manufacturing operations at Devens in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs). Ability to understa...
They are seeking a dynamic Director of Regulatory Strategy to steer our groundbreaking projects through the complex regulatory landscape with vision and precision. Director, Regulatory Strategy. Bachelor's degree in a relevant life sciences field with at least 8 years of experience in the biopharmac...
They are looking to add a Regulatory lead to head up the EU side of the Regulatory department. Senior Director of Regulatory Affairs - Responsibilities:. Collaborate with cross-functional teams, including clinical development, medical affairs, and quality assurance, to ensure regulatory compliance a...
Our team is diverse, with skillsets and responsibilities ranging from graphic design, content creation and performance marketing to internal communications and loyalty & rewards programs. Online and Retail Discounts, Company Match 401(k), Physical and Mental Health Wellness programs, and more!. ...
Experienced with the preparation and submission of regulatory documents, including PIND meeting packages, INDs, NDAs, ANDAs, regulatory correspondence, and amendments. Well established European pharmaceutical firm that supports the pharmaceutical industry with Intermediates, API's, Drug Products and...
Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projects, and issues, and responds timely to ensure re...
Who you are - Commercial Compliance Analyst. Represent the Compliance Team, as needed, by actively participating in Institutional Projects and communicating follow up items, compliance considerations, and areas of concern back to the team. As a member of our Compliance Department, you will join a dy...
Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of global product labeling materials. Employs a current...
As a Trade Compliance Analyst, you will play a key role in ensuring our company's compliance with global customs authorities and facilitating day-to-day trade compliance activities. Are you an enthusiastic professional looking to expand your experience or start a career in Trade and Compliance? Rand...
As the Associate Director of Regulatory CMC, reporting to the Director of Regulatory CMC, you will be pivotal in managing the development and submission of regulatory filings for gene therapy projects both domestically and internationally. Identify and articulate regulatory opportunities and challen...
Regulatory Affairs Certification (RAC) or equivalent preferred. Ensure that all products and processes comply with applicable regulatory requirements (e. Prepare and submit regulatory documentation and applications, including product registrations, certifications, and renewals. ...
A Senior Project Manager in Project Development & Resource Planning will work collaboratively with the Asset Management sponsors to develop complex electrical construction projects. National Grid is hiring a Senior Project Manager, Electricity Capital Project Delivery. Develop complex project sc...
Collaborates with other functional work teams , Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projec...
The team demands an analytical problem solver who can bring solutions to the table and take charge of multiple projects simultaneously. As a front-line employee, you will interact with owners, property adjusters, property managers, and trades people daily. Ability to manage multiple projects and peo...
Working with the Program Director and with oversight provided by the Inpatient Operations Director, provides operational support to the Inpatient Campus Programs. Inpatient ATS (Acute Treatment Services) Program - Westborough, MA. Working knowledge of computer programs such as Microsoft Word and Exc...
The Lead Compliance Specialist will perform critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization. The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with ta...
Ocular Therapeutix is seeking a highly motivated Senior Program Manager/Associate Director to join its Program Management team, with a focus on clinical and strategic alliance programs. This individual will lead core/program and sub-team initiatives, ensuring alignment with corporate objectives. The...