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...
They are looking to add a Regulatory lead to head up the EU side of the Regulatory department. Mantell Associates is partnered with a mid-size Biotech company focusing on pushing a BLA forward with their lead Rare Disease product currently in phase 3. Senior Director of Regulatory Affairs - Responsi...
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...
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...
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...
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. ...
Collaborating on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders. Monitor and analyze the external regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working gr...
This requisition can hire at three levels: Assistant Project Manager – Natural Resources; typically, with up to three (3) years of relevant experience and expertise Associate Project Manager – Natural Resources; typically, with up to five (5) years of relevant experience and expertise. The responsib...
What is the Compliance Analyst responsible for?. Create summary reports to Compliance and Business Management that detail compliance findings and corrective actions. What is the Compliance group responsible for?. Franklin Templeton’s Global Compliance team provides oversight and guidance to the vari...
Regulatory Compliance & Quality Systems Specialist / Sr. Specialist – looking for - staff in this area, also with + years of experience supporting oper ations regulatory inspections, audits, and working within the. Familiar with US FDA CFRs, regulatory guidance, and cGMPs; prior experience in an aud...
Assist Project Manager and General Superintendent with project tasks. Assistant Project Manager Responsibilities:. Ensure projects are built to contract plans and specifications and preform project quality inspections. Maintain and distribute project documents for multiple projects. ...
Berkley Accident and Health team (BAH)! You will be responsible for the collaboration of design, development, implementation, and support for all compliance programs, both at the corporate and business unit level for the company. Collaborate with business partners on drafting compliance policies, pr...
This 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 talent...
Individual Contributor responsible for QA Compliance Strategy for clinical and pre-commercial cell and gene therapies. Oversees contract manufacturing organizations (CMOs), monitoring information requests, reviewing CMO work, and following up on compliance-related items. Develops compliant Quality p...
We expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. May act as a submission compliance liaison with other areas of Regulatory A...
Responsible for the development, tracking, and management of project scope, schedule, costs, resource plans, issues and risks, as well as maintaining project and product quality for projects assigned. Ensure successful project integration management in AD&L, plan and monitor stakeholder manageme...
Leads the Regulatory Affairs team to design and execute regulatory strategy for approval and commercialization of the company’s products, including preparation, review, and submission of appropriate background documents and regulatory submissions. Senior Vice President, Regulatory Affairs. Keeps exe...
The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technical documentation and conduct other elements of sustaining Regulatory Affairs including maintaining “state of the art”. In addition, this position will support the regulatory department by maintaining data within reg...
This 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 talent...
This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. Title: Regulatory Affairs Manager. The Regulatory Affairs Manager will be re...
Compliance Specialist – Rate Filing. Be sure to include your preferred contact information as one of our Qualification Specialists will connect with you promptly. ...
The role will be responsible to work through multiple levels within the organization and external stakeholders to influence and drive Waters Quality, Regulatory & Clinical Affairs strategy to support Waters business growth and success of the Clinical organization. Lead the Global Design Quality Assu...
The IT Governance, Risk, and Compliance Specialist will play a key role on the iboss team by aligning security initiatives with enterprise programs and business objectives. The IT GRC Specialist will make an impact on iboss’ security program and services through experience with various areas includi...
Actively participates in continuous improvement opportunities to identify efficiencies and compliance improvements to benefit department operations or the organization at large. Authors (or assists in authoring) new or revised standard operating procedures (SOPs) for the QA department to satisfy new...
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...